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Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for the Treatment of Ambulatory Adult and Pediatric Patients With COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04425629
Recruitment Status : Terminated (Emerging SARS-CoV-2 variants impacting susceptibility to study drug)
First Posted : June 11, 2020
Results First Posted : December 21, 2023
Last Update Posted : December 21, 2023
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition COVID-19
Intervention Drug: casirivimab+imdevimab combination therapy
Enrollment 10078
Recruitment Details  
Pre-assignment Details 10065 were randomized, 135 randomized but not treated
Arm/Group Title Phase 1 Symptomatic: Placebo Phase 1 Symptomatic: 2.4 IV Phase 1 Symptomatic: 8.0 IV Phase 2 Symptomatic: Placebo Phase 2 Symptomatic: 2.4 IV Phase 2 Symptomatic: 8.0 IV Phase 2 Asymptomatic: Placebo Phase 2 Asymptomatic: 2.4 IV Phase 2 Asymptomatic: 8.0 IV Phase 3 Age>=18: Placebo Phase 3 Age>=18: 1.2 IV Phase 3 Age>=18: 2.4 IV Phase 3 Age>=18: 8.0 IV Phase 3 Age <18: Placebo Phase 3 Age <18: 1.2 IV Phase 3 Age <18: 2.4 IV Phase 3 Pregnant Placebo Phase 3 Pregnant 1.2 IV Phase 3 Pregnant: 2.4 IV
Hide Arm/Group Description Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19 2.4g of R10933 + R10987 Adult Symptomatic Participants with COVID-19 8.0g of R10933 + R10987 Adult Symptomatic Participants with COVID-19 Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19 2.4g of R10933 + R10987 Adult Symptomatic Participants with COVID-19 8.0g of R10933 + R10987 Adult Symptomatic Participants with COVID-19 Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection 2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection 8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection Placebo of R10933 + R10987 Participants >= 18 with COVID-19, not pregnant at randomization 1.2g of R10933 + R10987 Participants >= 18 with COVID-19, not pregnant at randomization 2.4g of R10933 + R10987 Participants >= 18 with COVID-19, not pregnant at randomization 8.0g of R10933 + R10987 Participants >= 18 with COVID-19, not pregnant at randomization Placebo of R10933 + R10987 Participants <18 with COVID-19, not pregnant at randomization 1.2g of R10933 + R10987 Participants <18 with COVID-19 2.4g of R10933 + R10987 Participants <18 with COVID-19 Placebo of R10933 + R10987 Participants who are pregnant with COVID-19 1.2g of R10933 + R10987 Participants who are pregnant with COVID-19 2.4g of R10933 + R10987 Participants who are pregnant with COVID-19
Period Title: Overall Study
Started 24 24 24 242 242 243 76 76 76 2378 2156 3189 1027 2 129 75 3 43 36
Completed 23 19 22 230 232 233 71 73 74 2217 1974 2947 962 2 123 65 2 40 33
Not Completed 1 5 2 12 10 10 5 3 2 161 182 242 65 0 6 10 1 3 3
Reason Not Completed
Adverse Event             0             0             0             0             1             0             0             0             0             3             2             1             1             0             0             0             0             0             0
Lost to Follow-up             1             3             1             7             1             2             1             0             1             64             70             98             30             0             5             4             0             3             1
Subject Decision             0             2             1             3             6             6             3             3             1             70             95             124             25             0             1             4             1             0             2
Death             0             0             0             0             0             0             0             0             0             11             2             4             0             0             0             0             0             0             0
Sponsor Request             0             0             0             2             2             2             1             0             0             9             9             10             8             0             0             1             0             0             0
Physician Decision             0             0             0             0             0             0             0             0             0             4             3             5             1             0             0             1             0             0             0
Lack of Efficacy             0             0             0             0             0             0             0             0             0             0             1             0             0             0             0             0             0             0             0
Arm/Group Title Phase 1 Symptomatic: Placebo Phase 1 Symptomatic: 2.4 IV Phase 1 Symptomatic: 8.0 IV Phase 2 Symptomatic: Placebo Phase 2 Symptomatic: 2.4 IV Phase 2 Symptomatic: 8.0 IV Phase 2 Asymptomatic: Placebo Phase 2 Asymptomatic: 2.4 IV Phase 2 Asymptomatic: 8.0 IV Phase 3 Age>=18: Placebo Phase 3 Age>=18: 1.2 IV Phase 3 Age>=18: 2.4 IV Phase 3 Age>=18: 8.0 IV Phase 3 Age <18: Placebo Phase 3 Age <18: 1.2 IV Phase 3 Age <18: 2.4 IV Phase 3 Pregnant Placebo Phase 3 Pregnant 1.2 IV Phase 3 Pregnant: 2.4 IV Total
Hide Arm/Group Description Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19 2.4g of R10933 + R10987 Adult Symptomatic Participants with COVID-19 8.0g of R10933 + R10987 Adult Symptomatic Participants with COVID-19 Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19 2.4g of R10933 + R10987 Adult Symptomatic Participants with COVID-19 8.0g of R10933 + R10987 Adult Symptomatic Participants with COVID-19 Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection 2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection 8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection Placebo of R10933 + R10987 Participants >=18 with COVID-19, not pregnant at randomization 1.2g of R10933 + R10987 Participants >=18 with COVID-19, not pregnant at randomization 2.4g of R10933 + R10987 Participants >=18 with COVID-19, not pregnant at randomization 8.0g of R10933 + R10987 Participants >=18 with COVID-19, not pregnant at randomization Placebo of R10933 + R10987 Participants <18 with COVID-19, not pregnant at randomization 1.2g of R10933 + R10987 Participants <18 with COVID-19 2.4g of R10933 + R10987 Participants <18 with COVID-19 Placebo of R10933 + R10987 Participants who are pregnant with COVID-19 1.2g of R10933 + R10987 Participants who are pregnant with COVID-19 2.4g of R10933 + R10987 Participants who are pregnant with COVID-19 Total of all reporting groups
Overall Number of Baseline Participants 24 24 24 242 242 243 76 76 76 2378 2156 3189 1027 2 129 75 3 43 36 10065
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 24 participants 24 participants 24 participants 242 participants 242 participants 243 participants 76 participants 76 participants 76 participants 2378 participants 2156 participants 3189 participants 1027 participants 2 participants 129 participants 75 participants 3 participants 43 participants 36 participants 10065 participants
40.5
(18 to 72)
39.5
(18 to 65)
39.0
(20 to 72)
42.0
(18 to 89)
43.0
(18 to 85)
42.0
(19 to 80)
43.5
(18 to 80)
44.5
(18 to 75)
44.5
(18 to 84)
46.0
(18 to 92)
48.0
(18 to 93)
46.0
(18 to 96)
44.0
(18 to 90)
14.0
(12 to 16)
11.0
(0 to 17)
12.0
(3 to 17)
33.0
(27 to 33)
30.0
(19 to 41)
28.0
(17 to 41)
45.0
(0 to 96)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 24 participants 24 participants 242 participants 242 participants 243 participants 76 participants 76 participants 76 participants 2378 participants 2156 participants 3189 participants 1027 participants 2 participants 129 participants 75 participants 3 participants 43 participants 36 participants 10065 participants
<18
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
 100.0%
129
 100.0%
75
 100.0%
0
   0.0%
0
   0.0%
1
   2.8%
207
   2.1%
>=18, <65
22
  91.7%
23
  95.8%
23
  95.8%
226
  93.4%
223
  92.1%
228
  93.8%
71
  93.4%
62
  81.6%
65
  85.5%
2159
  90.8%
1937
  89.8%
2843
  89.2%
911
  88.7%
0
   0.0%
0
   0.0%
0
   0.0%
3
 100.0%
43
 100.0%
35
  97.2%
8874
  88.2%
>=65
2
   8.3%
1
   4.2%
1
   4.2%
16
   6.6%
19
   7.9%
15
   6.2%
5
   6.6%
14
  18.4%
11
  14.5%
219
   9.2%
219
  10.2%
346
  10.8%
116
  11.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
984
   9.8%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 24 participants 24 participants 242 participants 242 participants 243 participants 76 participants 76 participants 76 participants 2378 participants 2156 participants 3189 participants 1027 participants 2 participants 129 participants 75 participants 3 participants 43 participants 36 participants 10065 participants
Female
10
  41.7%
14
  58.3%
10
  41.7%
122
  50.4%
130
  53.7%
136
  56.0%
40
  52.6%
37
  48.7%
32
  42.1%
1227
  51.6%
1117
  51.8%
1635
  51.3%
518
  50.4%
2
 100.0%
69
  53.5%
22
  29.3%
3
 100.0%
43
 100.0%
36
 100.0%
5203
  51.7%
Male
14
  58.3%
10
  41.7%
14
  58.3%
120
  49.6%
112
  46.3%
107
  44.0%
36
  47.4%
39
  51.3%
44
  57.9%
1151
  48.4%
1039
  48.2%
1554
  48.7%
509
  49.6%
0
   0.0%
60
  46.5%
53
  70.7%
0
   0.0%
0
   0.0%
0
   0.0%
4862
  48.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 24 participants 24 participants 242 participants 242 participants 243 participants 76 participants 76 participants 76 participants 2378 participants 2156 participants 3189 participants 1027 participants 2 participants 129 participants 75 participants 3 participants 43 participants 36 participants 10065 participants
American Indian or Alaska Native
1
   4.2%
0
   0.0%
0
   0.0%
2
   0.8%
1
   0.4%
1
   0.4%
0
   0.0%
0
   0.0%
0
   0.0%
30
   1.3%
72
   3.3%
84
   2.6%
5
   0.5%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.3%
0
   0.0%
197
   2.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
4
   1.7%
6
   2.5%
4
   1.6%
1
   1.3%
4
   5.3%
3
   3.9%
89
   3.7%
71
   3.3%
96
   3.0%
45
   4.4%
0
   0.0%
1
   0.8%
1
   1.3%
0
   0.0%
0
   0.0%
0
   0.0%
325
   3.2%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
3
   0.1%
7
   0.3%
6
   0.2%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.3%
0
   0.0%
17
   0.2%
Black or African American
3
  12.5%
7
  29.2%
0
   0.0%
21
   8.7%
20
   8.3%
23
   9.5%
6
   7.9%
3
   3.9%
5
   6.6%
110
   4.6%
112
   5.2%
172
   5.4%
46
   4.5%
1
  50.0%
8
   6.2%
7
   9.3%
1
  33.3%
4
   9.3%
2
   5.6%
551
   5.5%
White
20
  83.3%
16
  66.7%
23
  95.8%
207
  85.5%
208
  86.0%
207
  85.2%
65
  85.5%
69
  90.8%
65
  85.5%
2010
  84.5%
1704
  79.0%
2612
  81.9%
889
  86.6%
1
  50.0%
115
  89.1%
63
  84.0%
2
  66.7%
35
  81.4%
33
  91.7%
8344
  82.9%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
3
   1.2%
1
   0.4%
3
   1.2%
2
   2.6%
0
   0.0%
3
   3.9%
82
   3.4%
138
   6.4%
143
   4.5%
21
   2.0%
0
   0.0%
3
   2.3%
2
   2.7%
0
   0.0%
1
   2.3%
0
   0.0%
402
   4.0%
Unknown or Not Reported
0
   0.0%
1
   4.2%
1
   4.2%
5
   2.1%
6
   2.5%
5
   2.1%
2
   2.6%
0
   0.0%
0
   0.0%
54
   2.3%
52
   2.4%
76
   2.4%
21
   2.0%
0
   0.0%
2
   1.6%
2
   2.7%
0
   0.0%
1
   2.3%
1
   2.8%
229
   2.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 24 participants 24 participants 242 participants 242 participants 243 participants 76 participants 76 participants 76 participants 2378 participants 2156 participants 3189 participants 1027 participants 2 participants 129 participants 75 participants 3 participants 43 participants 36 participants 10065 participants
Hispanic or Latino
8
  33.3%
11
  45.8%
17
  70.8%
129
  53.3%
121
  50.0%
117
  48.1%
34
  44.7%
43
  56.6%
35
  46.1%
1002
  42.1%
1140
  52.9%
1413
  44.3%
316
  30.8%
0
   0.0%
87
  67.4%
40
  53.3%
0
   0.0%
6
  14.0%
8
  22.2%
4527
  45.0%
Not Hispanic or Latino
16
  66.7%
12
  50.0%
6
  25.0%
112
  46.3%
121
  50.0%
126
  51.9%
40
  52.6%
33
  43.4%
39
  51.3%
1357
  57.1%
992
  46.0%
1740
  54.6%
701
  68.3%
2
 100.0%
42
  32.6%
33
  44.0%
2
  66.7%
37
  86.0%
28
  77.8%
5439
  54.0%
Not Reported
0
   0.0%
1
   4.2%
1
   4.2%
1
   0.4%
0
   0.0%
0
   0.0%
2
   2.6%
0
   0.0%
2
   2.6%
19
   0.8%
24
   1.1%
36
   1.1%
10
   1.0%
0
   0.0%
0
   0.0%
2
   2.7%
1
  33.3%
0
   0.0%
0
   0.0%
99
   1.0%
Race  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 24 participants 24 participants 242 participants 242 participants 243 participants 76 participants 76 participants 76 participants 2378 participants 2156 participants 3189 participants 1027 participants 2 participants 129 participants 75 participants 3 participants 43 participants 36 participants 10065 participants
White
20
  83.3%
16
  66.7%
23
  95.8%
207
  85.5%
208
  86.0%
207
  85.2%
65
  85.5%
69
  90.8%
65
  85.5%
2010
  84.5%
1704
  79.0%
2612
  81.9%
889
  86.6%
1
  50.0%
115
  89.1%
63
  84.0%
2
  66.7%
35
  81.4%
33
  91.7%
8344
  82.9%
Black or African American
3
  12.5%
7
  29.2%
0
   0.0%
21
   8.7%
20
   8.3%
23
   9.5%
6
   7.9%
3
   3.9%
5
   6.6%
110
   4.6%
112
   5.2%
172
   5.4%
46
   4.5%
1
  50.0%
8
   6.2%
7
   9.3%
1
  33.3%
4
   9.3%
2
   5.6%
551
   5.5%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
4
   1.7%
6
   2.5%
4
   1.6%
1
   1.3%
4
   5.3%
3
   3.9%
89
   3.7%
71
   3.3%
96
   3.0%
45
   4.4%
0
   0.0%
1
   0.8%
1
   1.3%
0
   0.0%
0
   0.0%
0
   0.0%
325
   3.2%
American Indian or Alaska Native
1
   4.2%
0
   0.0%
0
   0.0%
2
   0.8%
1
   0.4%
1
   0.4%
0
   0.0%
0
   0.0%
0
   0.0%
30
   1.3%
72
   3.3%
84
   2.6%
5
   0.5%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.3%
0
   0.0%
197
   2.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
3
   0.1%
7
   0.3%
6
   0.2%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.3%
0
   0.0%
17
   0.2%
Unknown
0
   0.0%
0
   0.0%
0
   0.0%
3
   1.2%
1
   0.4%
3
   1.2%
2
   2.6%
0
   0.0%
3
   3.9%
82
   3.4%
138
   6.4%
143
   4.5%
21
   2.0%
0
   0.0%
3
   2.3%
2
   2.7%
0
   0.0%
1
   2.3%
0
   0.0%
402
   4.0%
Not Reported
0
   0.0%
1
   4.2%
1
   4.2%
5
   2.1%
6
   2.5%
5
   2.1%
2
   2.6%
0
   0.0%
0
   0.0%
54
   2.3%
52
   2.4%
76
   2.4%
21
   2.0%
0
   0.0%
2
   1.6%
2
   2.7%
0
   0.0%
1
   2.3%
1
   2.8%
229
   2.3%
Age Continous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants 24 participants 24 participants 242 participants 242 participants 243 participants 76 participants 76 participants 76 participants 2378 participants 2156 participants 3189 participants 1027 participants 2 participants 129 participants 75 participants 3 participants 43 participants 36 participants 10065 participants
43.8  (14.42) 38.9  (11.11) 40.4  (11.83) 42.5  (15.21) 42.7  (15.59) 41.7  (14.38) 43.5  (15.51) 44.8  (16.70) 44.0  (17.43) 45.4  (14.61) 46.7  (14.59) 46.1  (14.89) 44.8  (15.09) 14.0  (2.83) 10.9  (4.14) 12.2  (3.36) 31.0  (3.46) 28.9  (5.87) 28.3  (6.02) 44.7  (15.51)
1.Primary Outcome
Title Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) - [Ph1, Ph2, Ph3 Cohort 1 - Cohort 3]
Hide Description

Primary:

Phase 1, Phase 3 (Cohort 2 and Cohort 3)

Secondary:

Phase 2, Phase 3 (Cohort 1)
Time Frame Through Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis populations were prespecified in the SAP. Pooled analyses were performed for symptomatic adult participants randomized in Phase 1, 2, or 3 (cohort 1) on or before 2/24/21 to placebo, R10933+R10987 1.2 g, 2.4 g, or 8.0 g IV. No phase 1 or 2 participants were randomized to R10933+R10987 1.2 g IV. Asymptomatic adult participants randomized to the asymptomatic cohort of phase 2, symptomatic pediatric / pregnant participants randomized in phase 3 to cohort 2 or 3 were analyzed separately
Arm/Group Title Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (Placebo) Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (2.4 IV) Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (8.0 IV) Phase 2 Asymptomatic (Placebo) Phase 2 Asymptomatic (2.4g IV) Phase 2 Asymptomatic (8.0g IV) Phase 3 Cohort 1 (1.2g IV) Symptomatic Phase 3 Cohort 2 Pediatric (Placebo) Phase 3 Cohort 2 Pediatric (1.2g IV) Phase 3 Cohort 2 Pediatric (2.4g IV) Phase 3 Cohort 3 Pregnant (Placebo) Phase 3 Cohort 3 Pregnant (1.2g IV) Phase 3 Cohort 3 Pregnant (2.4g IV)
Hide Arm/Group Description:
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
Pooled analysis of Phases 1, 2, & 3 Cohort 1 Symptomatic Participants for dosage of 2.4g IV
Pooled analysis of Phases 1, 2, & 3 Cohort 1 Symptomatic Participants for dosage of 8.0g IV
Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
Phase 3 Cohort 1(1.2g IV) Symptomatic Participants
Phase 3 Cohort 2 Pediatric (Placebo)
Phase 3 Cohort 2 Pediatric (1.2g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
Phase 3 Cohort 3 Pregnant (Placebo)
Phase 3 Cohort 3 Pregnant (1.2g IV)
Phase 3 Cohort 3 Pregnant (2.4g IV)
Overall Number of Participants Analyzed 2609 2614 1272 74 72 73 1329 2 129 71 2 43 35
Measure Type: Count of Participants
Unit of Measure: Participants
97
   3.7%
31
   1.2%
19
   1.5%
0
   0.0%
0
   0.0%
0
   0.0%
14
   1.1%
0
   0.0%
2
   1.6%
0
   0.0%
0
   0.0%
2
   4.7%
2
   5.7%
2.Primary Outcome
Title Number of Participants With Infusion-related Reactions (Ph1, Ph2, Ph3 Cohort 1 - Cohort 3)
Hide Description

Primary:

Phase 1, Phase 3 (Cohort 2 and Cohort 3)

Secondary:

Phase 2, Phase 3 (Cohort 1)
Time Frame Through Day 4
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis populations were prespecified in the SAP. Pooled analyses were performed for symptomatic adult participants randomized in Phase 1, 2, or 3 (cohort 1) on or before 2/24/21 to placebo, R10933+R10987 1.2 g, 2.4 g, or 8.0 g IV. No phase 1 or 2 participants were randomized to R10933+R10987 1.2 g IV. Asymptomatic adult participants randomized to the asymptomatic cohort of phase 2, symptomatic pediatric / pregnant participants randomized in phase 3 to cohort 2 or 3 were analyzed separately.
Arm/Group Title Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (Placebo) Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (2.4g IV) Combined Phases 1,2, & 3 Cohort 1 Symptomatic (8.0g IV) Phase 2 Asymptomatic (Placebo) Phase 2 Asymptomatic (2.4g IV) Phase 2 Asymptomatic (8.0g IV) Phase 3 Cohort 1 (1.2g IV) Symptomatic Phase 3 Cohort 2 Pediatric (Placebo) Phase 3 Cohort 2 Pediatric (1.2g IV) Phase 3 Cohort 2 Pediatric (2.4g IV) Phase 3 Cohort 3 Pregnant (Placebo) Phase 3 Cohort 3 Pregnant (1.2g IV) Phase 3 Cohort 3 Pregnant (2.4g IV)
Hide Arm/Group Description:
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
Pooled analysis of Phases 1, 2, & 3 Cohort 1 Symptomatic Participants for dosage of 2.4g IV
Pooled analysis of Phases 1, 2, & 3 Cohort 1 Symptomatic Participants for dosage of 8.0g IV
Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
Phase 3 Cohort 1 Symptomatic Participants for dosage of 1.2g IV
Phase 3 Cohort 2 Pediatric (Placebo)
Phase 3 Cohort 2 Pediatric (1.2g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
Phase 3 Cohort 3 Pregnant (Placebo)
Phase 3 Cohort 3 Pregnant (1.2g IV)
Phase 3 Cohort 3 Pregnant (2.4g IV)
Overall Number of Participants Analyzed 2609 2614 1272 74 72 73 1329 2 129 71 2 43 35
Measure Type: Count of Participants
Unit of Measure: Participants
2
   0.1%
4
   0.2%
7
   0.6%
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.1%
0
   0.0%
0
   0.0%
1
   1.4%
0
   0.0%
0
   0.0%
0
   0.0%
3.Primary Outcome
Title Number of Participants With Hypersensitivity Reactions (Ph1, Ph2, Ph3 Cohort 1 - Cohort 3)
Hide Description

Primary:

Phase 1, Phase 3 (Cohort 2 and Cohort 3)

Secondary:

Phase 2, Phase 3 (Cohort 1)
Time Frame Through Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis populations were prespecified in the SAP. Pooled analyses were performed for symptomatic adult participants randomized in Phase 1, 2, or 3 (cohort 1) on or before 2/24/21 to placebo, R10933+R10987 1.2 g, 2.4 g, or 8.0 g IV. No phase 1 or 2 participants were randomized to R10933+R10987 1.2 g IV. Asymptomatic adult participants randomized to the asymptomatic cohort of phase 2, symptomatic pediatric / pregnant participants randomized in phase 3 to cohort 2 or 3 were analyzed separately.
Arm/Group Title Combined Phases 1,2, & 3 Cohort 1 Symptomatic (Placebo) Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (2.4g IV) Combined Phases 1,2, & 3 Cohort 1 Symptomatic (8.0g IV) Phase 2 Asymptomatic (Placebo) Phase 2 Asymptomatic (2.4g IV) Phase 2 Asymptomatic (8.0g IV) Phase 3 Cohort 1 (1.2g IV) Symptomatic Phase 3 Cohort 2 Pediatric (Placebo) Phase 3 Cohort 2 Pediatric (1.2g IV) Phase 3 Cohort 2 Pediatric (2.4g IV) Phase 3 Cohort 3 Pregnant (Placebo) Phase 3 Cohort 3 Pregnant (1.2g IV) Phase 3 Cohort 3 Pregnant (2.4g IV)
Hide Arm/Group Description:
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
Pooled analysis of Phases 1, 2, & 3 Cohort 1 Symptomatic Participants for dosage of 2.4g IV
8.0g of R10933 + R10987 Adult Symptomatic Participants with COVID-19
Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
Phase 3 Cohort 1 Symptomatic Participants for dosage of 1.2g IV
Phase 3 Cohort 2 Pediatric (Placebo)
Phase 3 Cohort 2 Pediatric (1.2g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
Phase 3 Cohort 3 Pregnant (Placebo)
Phase 3 Cohort 3 Pregnant (1.2g IV)
Phase 3 Cohort 3 Pregnant (2.4g IV)
Overall Number of Participants Analyzed 2609 2614 1272 74 72 73 1329 2 129 71 2 43 35
Measure Type: Number
Unit of Measure: Participants
3 1 0 0 0 0 1 0 1 0 0 0 0
4.Primary Outcome
Title Time-weighted Average Change From Baseline in Viral Load (log10 Copies/mL) From Day 1 to Day 7, as Measured by Quantitative Reverse Transcription Quantitative Polymerase Chain Reaction (RT-qPCR) in Nasopharyngeal (NP) Swab Samples (Ph1, Ph2)
Hide Description

Primary:

Phase 1, Phase 2
Time Frame Baseline up to Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants in Phase 1 or Phase 2 with qualitatively positive RT-qPCR in NP swab samples at randomization or collected within 2 hours after study drug infusion was initiated. This pooled modified full analysis set (mFAS) includes all randomized patients with positive RT-qPCR in NP swab samples at randomization and is based on the treatment allocated (as randomized).
Arm/Group Title Phase 1 + Phase 2 Symptomatic (Placebo) Phase 1 + Phase 2 Symptomatic (2.4g IV) Phase 1 + Phase 2 Symptomatic (8.0g IV)
Hide Arm/Group Description:
Pooled Phase 1 + Phase 2 Symptomatic Placebo Participants
Pooled Phase 1 + Phase 2 Symptomatic 2.4g IV Participants
Pooled Phase 1 + Phase 2 Symptomatic 8.0g IV Participants
Overall Number of Participants Analyzed 232 219 220
Mean (Standard Deviation)
Unit of Measure: log10 copies/mL
-1.32  (1.047) -1.65  (0.977) -1.67  (1.157)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Phase 1 + Phase 2 Symptomatic (Placebo), Phase 1 + Phase 2 Symptomatic (2.4g IV)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value = 0.0006
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value -0.33
Confidence Interval (2-Sided) 95%
-0.52 to -0.14
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.10
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Phase 1 + Phase 2 Symptomatic (Placebo), Phase 1 + Phase 2 Symptomatic (8.0g IV)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value -0.37
Confidence Interval (2-Sided) 95%
-0.56 to -0.19
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.10
Estimation Comments [Not Specified]
5.Primary Outcome
Title Proportion of Participants With at Least One (≥1) COVID-19-related Hospitalization or All-cause Death (Ph3 Cohort 1- 1.2g vs Placebo)
Hide Description Phase 3 Cohort 1
Time Frame Through Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Arm/Group Title Phase 3 Cohort 1 (Placebo) >=18 Phase 3 Cohort 1 (1.2g IV) >= 18
Hide Arm/Group Description:
Phase 3 Cohort 1 (Placebo)
Phase 3 Cohort 1 (1.2g IV)
Overall Number of Participants Analyzed 748 736
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
3.2
(2.1 to 4.7)
1.0
(0.4 to 1.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Phase 3 Cohort 1 (Placebo) >=18, Phase 3 Cohort 1 (1.2g IV) >= 18
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value = 0.0024
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
6.Primary Outcome
Title Proportion of Participants With at Least One (≥1) COVID-19-related Hospitalization or All-cause Death (Ph3 Cohort 1 - 2.4g vs Placebo)
Hide Description

Primary:

Phase 3 (Cohort 1)
Time Frame Through Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Arm/Group Title Phase 3 Cohort 1 (Placebo) >=18 Phase 3 Cohort 1 (2.4g IV) >= 18
Hide Arm/Group Description:
Phase 3 Cohort 1 (Placebo)
Phase 3 Cohort 1 (2.4g IV)
Overall Number of Participants Analyzed 1341 1355
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
4.6
(3.6 to 5.9)
1.3
(0.8 to 2.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Phase 3 Cohort 1 (Placebo) >=18, Phase 3 Cohort 1 (2.4g IV) >= 18
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
7.Primary Outcome
Title Concentration of REGN10983 + REGN10987 in Serum Over Time (Ph3 Cohort 2)
Hide Description

Phase 3 Cohort 2

[Nominal Sampling Time] = [Clinical Study Time (Visit Day - 1)]
Time Frame Up to Nominal Sampling Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetics (PK) analysis population includes all patients who received any study drug (safety population) and who had at least 1 non-missing result following the first dose of study drug
Arm/Group Title Phase 3 Cohort 2 Pediatric (1.2g IV) Phase 3 Cohort 2 Pediatric (2.4g IV)
Hide Arm/Group Description:
Phase 3 Cohort 2 Pediatric (1.2g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
Overall Number of Participants Analyzed 129 71
Mean (Standard Deviation)
Unit of Measure: mg/L
Day 0: End of Infusion Number Analyzed 107 participants 51 participants
402  (196) 710  (275)
Nominal Sampling Day 28 Number Analyzed 94 participants 48 participants
108  (60.1) 198  (78.7)
8.Secondary Outcome
Title Time to COVID-19 Symptoms Resolution (Ph3 Cohort 1 - 1.2g vs Placebo)
Hide Description Phase 3 Cohort 1
Time Frame Up to Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Arm/Group Title Phase 3 Cohort 1 (Placebo) Phase 3 Cohort 1 (1.2 g IV)
Hide Arm/Group Description:
Phase 3 Cohort 1 (Placebo)
Phase 3 Cohort 1 (1.2 g IV) - Post PA6 mFAS
Overall Number of Participants Analyzed 680 673
Median (95% Confidence Interval)
Unit of Measure: Days
14.0
(13.0 to 16.0)
10.0
(9.0 to 12.0)
9.Secondary Outcome
Title Time to COVID-19 Symptoms Resolution (Ph3 Cohort 1 - 2.4g vs Placebo)
Hide Description Phase 3 (Cohort 1)
Time Frame Through Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Arm/Group Title Phase 3 Age>=18: Placebo Phase 3 Age>=18: 2.4 IV
Hide Arm/Group Description:
Placebo of R10933 + R10987 Participants >= 18 with COVID-19, not pregnant at randomization
2.4g of R10933 + R10987 Participants >= 18 with COVID-19, not pregnant at randomization
Overall Number of Participants Analyzed 1197 1214
Median (95% Confidence Interval)
Unit of Measure: Days
14.0
(13.0 to 15.0)
10.0
(10.0 to 11.0)
10.Secondary Outcome
Title Proportion of Participants With ≥1 COVID-19-related Hospitalization or All-cause Death From Day 4 Through Day 29 (Ph3 Cohort 1 - 1.2g vs. Placebo)
Hide Description Phase 3 (Cohort 1)
Time Frame Day 4 thru Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Arm/Group Title Phase 3 Cohort 1 (Placebo) >=18 Phase 3 Cohort 1 (1.2g IV) >= 18
Hide Arm/Group Description:
Phase 3 Cohort 1 (Placebo)
Phase 3 Cohort 1 (1.2g IV)
Overall Number of Participants Analyzed 735 748
Measure Type: Number
Unit of Measure: Participants
5 18
11.Secondary Outcome
Title Proportion of Participants With ≥1 COVID-19-related Hospitalization or All-cause Death From Day 4 Through Day 29 (Ph3 Cohort 1 - 2.4g vs. Placebo)
Hide Description Phase 3 (Cohort 1)
Time Frame From Day 4 Through Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Arm/Group Title Phase 3 Cohort 1 (Placebo) >=18 Phase 3 Cohort 1 (2.4g IV) >= 18
Hide Arm/Group Description:
Phase 3 Cohort 1 (Placebo)
Phase 3 Cohort 1 (2.4g IV)
Overall Number of Participants Analyzed 1340 1351
Measure Type: Number
Unit of Measure: Participants
46 5
12.Secondary Outcome
Title Change From Baseline in Viral Load at Each Visit, as Measured by RT-qPCR in Nasopharyngeal Swabs (Next Phase 2 Cohort)
Hide Description Next Phase 2 Symptomatic
Time Frame Day 5, Day 7, Day 15, Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Participants analyzed are part of modified Full Analysis Set (mFAS) and have documented status at baseline. Next Phase 2 participants included the next 524 participants randomized to Phase 2 subsequent to the first 275 symptomatic participants randomized in Phase 1 / 2
Arm/Group Title Next Phase 2 (Placebo) Next Phase 2 (2.4g IV) Next Phase 2 (8.0g IV)
Hide Arm/Group Description:
Next Phase 2 Placebo Participants
Next Phase 2 Participants 2.4g IV
Next Phase 2 Participants 8.0g IV
Overall Number of Participants Analyzed 151 145 146
Least Squares Mean (Standard Error)
Unit of Measure: log10 copies/mL
Day 5 Number Analyzed 141 participants 139 participants 137 participants
-1.79  (0.14) -2.33  (0.14) -2.28  (0.14)
Day 7 Number Analyzed 141 participants 139 participants 134 participants
-2.54  (0.13) -2.79  (0.13) -3.08  (0.13)
Day 15 Number Analyzed 138 participants 140 participants 134 participants
-4.56  (0.14) -4.67  (0.14) -4.58  (0.14)
Day 29 Number Analyzed 139 participants 136 participants 140 participants
-5.42  (0.10) -5.60  (0.10) -5.45  (0.10)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Next Phase 2 (Placebo), Next Phase 2 (2.4g IV)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value = 0.1903
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Next Phase 2 (Placebo), Next Phase 2 (8.0g IV)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value = 0.8431
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
13.Secondary Outcome
Title Time-weighted Average Change From Baseline in Viral Load (log10 Copies/mL) From Day 1 to Post-baseline Study Days (Ph1, Ph2)
Hide Description Phase 1, Phase 2
Time Frame Day 1 to Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants pooled in Phase 1 or Phase 2 with qualitatively positive RT-qPCR in NP swab samples at randomization or collected within 2 hours after study drug infusion was initiated. This modified full analysis set (mFAS) includes all randomized patients with positive RT-qPCR in NP swab samples at randomization and is based on the treatment allocated (as randomized).
Arm/Group Title Phase 1 + Phase 2 Symptomatic (Placebo) Phase 1 + Phase 2 Symptomatic (2.4g IV) Phase 1 + Phase 2 Symptomatic (8.0g IV)
Hide Arm/Group Description:
Pooled Phase 1 + Phase 2 Symptomatic Placebo Participants
Pooled Phase 1 + Phase 2 Symptomatic 2.4g IV Participants
Pooled Phase 1 + Phase 2 Symptomatic 8.0g IV Participants
Overall Number of Participants Analyzed 232 219 220
Least Squares Mean (Standard Error)
Unit of Measure: log10 copies/mL
TWA Change from BL: Day 1 to Day 5 Number Analyzed 221 participants 210 participants 213 participants
-0.93  (0.07) -1.23  (0.07) -1.25  (0.07)
TWA Change from BL: Day 1 to Day 7 Number Analyzed 224 participants 211 participants 214 participants
-1.35  (0.07) -1.68  (0.08) -1.72  (0.08)
TWA Change from BL: Day 1 to Day 15 Number Analyzed 224 participants 212 participants 216 participants
-2.57  (0.07) -2.93  (0.08) -2.96  (0.08)
TWA Change from BL: Day 1 to Day 29 Number Analyzed 224 participants 213 participants 216 participants
-3.74  (0.06) -3.97  (0.07) -4.03  (0.07)
14.Secondary Outcome
Title Percentage of Participants With ≥1 COVID-19-related Medically-attended Visit Through Day 29 (Ph1, Ph2)
Hide Description Phase 1, Phase 2
Time Frame Through Day 29
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Hide Analysis Population Description
All randomized participants pooled in Phase 1 or Phase 2 with qualitatively positive RT-qPCR in NP swab samples at randomization or collected within 2 hours after study drug infusion was initiated. This modified full analysis set (mFAS) includes all randomized patients with positive RT-qPCR in NP swab samples at randomization and is based on the treatment allocated (as randomized).
Arm/Group Title Phase 1 + Phase 2 Symptomatic (Placebo) Phase 1 + Phase 2 Symptomatic (2.4g IV) Phase 1 + Phase 2 Symptomatic (8.0g IV)
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Pooled Phase 1 + Phase 2 Symptomatic Placebo Participants
Pooled Phase 1 + Phase 2 Symptomatic 2.4g IV Participants
Pooled Phase 1 + Phase 2 Symptomatic 8.0g IV Participants
Overall Number of Participants Analyzed 232 219 220
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
7.8
(4.7 to 12.0)
3.2
(1.3 to 6.5)
2.7
(1.0 to 5.8)
15.Secondary Outcome
Title Percentage of Participants With ≥1 COVID-19 Related Hospitalization, Emergency Room, or Urgent Care Visit Through Day 29 (Ph1, Ph2)
Hide Description Phase 1, Phase 2
Time Frame Through Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants pooled in Phase 1 or Phase 2 with qualitatively positive RT-qPCR in NP swab samples at randomization or collected within 2 hours after study drug infusion was initiated. This modified full analysis set (mFAS) includes all randomized patients with positive RT-qPCR in NP swab samples at randomization and is based on the treatment allocated (as randomized).
Arm/Group Title Phase 1 + Phase 2 Symptomatic (Placebo) Phase 1 + Phase 2 Symptomatic (2.4g IV) Phase 1 + Phase 2 Symptomatic (8.0g IV)
Hide Arm/Group Description:
Pooled Phase 1 + Phase 2 Symptomatic Placebo Participants
Pooled Phase 1 + Phase 2 Symptomatic 2.4g IV Participants
Pooled Phase 1 + Phase 2 Symptomatic 8.0g IV Participants
Overall Number of Participants Analyzed 232 219 220
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
4.7
(2.4 to 8.3)
2.7
(1.0 to 5.9)
2.3
(0.7 to 5.2)
16.Secondary Outcome
Title Time to First Onset of Symptoms Consistent With COVID-19 (Phase 2 Asymptomatic Cohort Only)
Hide Description Phase 2 Only
Time Frame Up to Day 29
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Hide Analysis Population Description
Phase 2 asymptomatic cohort
Arm/Group Title Placebo Phase 2 Asymptomatic: 2.4 IV Phase 2 Asymptomatic: 8.0 IV
Hide Arm/Group Description:
Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
Overall Number of Participants Analyzed 74 72 73
Median (95% Confidence Interval)
Unit of Measure: Days
4.0 [1] 
(2.0 to NA)
NA [1] 
(NA to NA)
4.0 [1] 
(2.0 to NA)
[1]
Insufficient number of participants with events
17.Secondary Outcome
Title Proportion of Participants With ≥1 COVID-19-related Hospitalization, Emergency Room Visit, or All-cause Death (Ph3 Cohort 1) - Placebo vs. 1.2g IV
Hide Description Phase 3 Cohort 1 - Placebo vs. 1.2 g IV
Time Frame Through Day 29
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Hide Analysis Population Description
Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Arm/Group Title Phase 3 Cohort 1 (Placebo) >=18 Phase 3 Cohort 1 (1.2g IV) >= 18
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Phase 3 Cohort 1 (Placebo)
Phase 3 Cohort 1 (1.2g IV)
Overall Number of Participants Analyzed 748 736
Measure Type: Number
Unit of Measure: Participants
51 20
18.Secondary Outcome
Title Proportion of Participants With ≥1 COVID-19-related Hospitalization, Emergency Room Visit, or All-cause Death (Ph3 Cohort 1) - Placebo vs. 2.4g IV
Hide Description Phase 3 (Cohort 1)
Time Frame Through day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Arm/Group Title Phase 3 Cohort 1 (Placebo) >=18 Phase 3 Cohort 1 (2.4g IV) >= 18
Hide Arm/Group Description:
Phase 3 Cohort 1 (Placebo)
Phase 3 Cohort 1 (2.4g IV)
Overall Number of Participants Analyzed 1341 1355
Measure Type: Number
Unit of Measure: Participants
62 18
19.Secondary Outcome
Title Concentration of REGN10933 + REGN10987 in Serum Over Time (Ph1 Cohort 1, Ph2 Cohort 1, Ph3 Cohort 1 and Cohort 3)
Hide Description

Secondary:

Phase 1, Phase 2, Phase 3 (Cohort 1 and Cohort 3) - Symptomatic Participants

[Nominal Sampling Time] = [Clinical Study Time (Visit Day - 1)]
Time Frame Up to Nominal Sampling Day 28
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Hide Analysis Population Description
The pharmacokinetics (PK) analysis population includes all patients who received any study drug (safety population) and who had at least 1 non-missing result following the first dose of study drug
Arm/Group Title Phase 1 (2.4g IV) Phase 1 (8.0g IV) Phase 2 (2.4g IV) Phase 2 (8.0g IV) Phase 3 Cohort 1 (1.2g IV) Phase 3 Cohort 1 (2.4g IV) Phase 3 Cohort 1 (8.0g IV) Phase 3 Cohort 3 (1.2g IV) Phase 3 Cohort 3 (2.4g IV)
Hide Arm/Group Description:
Phase 1 (2.4g IV) - PK Analysis Set
Phase 1 (8.0g IV) - PK Analysis Set
Phase 2 (2.4g IV) - PK Analysis Set
Phase 2 (8.0g IV) - PK Analysis Set
Phase 3 Cohort 1 (1.2g IV) - PK Analysis Set
Phase 3 Cohort 1 (2.4g IV) - PK Analysis Set
Phase 3 Cohort 1 (8.0g IV) - PK Analysis Set
Phase 3 Cohort 3 (1.2g IV) - PK Analysis Set
Phase 3 Cohort 3 (2.4g IV) - PK Analysis Set
Overall Number of Participants Analyzed 18 20 218 237 3477 3477 881 22 37
Mean (Standard Deviation)
Unit of Measure: mg/L
Day 0: EOI 594  (276) 1652  (928) 701  (287) 2142  (815) 415  (178) 669  (236) 2239  (740) 305  (80.8) 536  (165)
Day 28 141  (97.5) 384  (143) 142  (62.5) 453  (179) 85.1  (36.9) 143  (55.1) 463  (166) 63.7  (25.9) 119  (31.1)
20.Secondary Outcome
Title Assessment of Pharmacokinetic (PK) Parameter: Maximum Serum Concentration Observed (Cmax) of REGN10933+REGN10987 (Phase 1)
Hide Description Phase 1 Only
Time Frame Through Day 29
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Hide Analysis Population Description
The pharmacokinetics (PK) analysis population includes all patients who received any study drug (safety population) and who had at least 1 non-missing result following the first dose of study drug
Arm/Group Title Phase 1 PK-AS
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Phase 1 PK-AS (Pharmacokinetic Analysis Set)
Overall Number of Participants Analyzed 45
Mean (Standard Deviation)
Unit of Measure: mg/L
2.4g IV Number Analyzed 22 participants
689  (391)
8.0g IV Number Analyzed 23 participants
1805  (720)
21.Secondary Outcome
Title Assessment of PK Parameter: Time to Cmax (Tmax) for REGN10933+REGN10987 (Phase 1)
Hide Description Phase 1 Only
Time Frame Through Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetics (PK) analysis population includes all patients who received any study drug (safety population) and who had at least 1 non-missing result following the first dose of study drug
Arm/Group Title Phase 1 PK-AS
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Phase 1 PK-AS (Pharmacokinetic Analysis Set)
Overall Number of Participants Analyzed 45
Median (Full Range)
Unit of Measure: Days
2.4g IV Number Analyzed 22 participants
27.7
(0.0847 to 28.2)
8.0g IV Number Analyzed 23 participants
0.0854
(0.0431 to 2.06)
22.Secondary Outcome
Title Assessment of PK Parameter: Area Under the Curve (AUC) Computed From Time Zero to Day 28 Concentration (AUC 0-28) for REGN10933+REGN10987 (Phase 1)
Hide Description Phase 1 Only
Time Frame Through Day 29
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Hide Analysis Population Description
The pharmacokinetics (PK) analysis population includes all patients who received any study drug (safety population) and who had at least 1 non-missing result following the first dose of study drug
Arm/Group Title Phase 1 PK-AS
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Phase 1 PK-AS (Pharmacokinetic Analysis Set)
Overall Number of Participants Analyzed 45
Mean (Standard Deviation)
Unit of Measure: day*milligram/Liter
2.4g IV Number Analyzed 19 participants
7158  (4255)
8.0g IV Number Analyzed 20 participants
19084  (5172)
23.Secondary Outcome
Title Immunogenicity as Measured by Anti-drug (ADA) to REGN10933 (Ph1 Cohort 1, Ph2 Cohort 1, Ph3 Cohort 1)
Hide Description Phase 1, Phase 2, Phase 3 (Cohort 1) - Pooled Symptomatic Participants
Time Frame Through Day 29
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Hide Analysis Population Description
The anti-drug antibody (ADA) analysis set (AAS) includes all subjects who received any study drug (safety population) and had at least one non-missing ADA result from the ADA assay after first dose of the study drug(s). Pooled participants will be analyzed according to the treatment actually received. This is an adaptive master protocol design, to allow for flexible adaptation for participants with symptomatic COVID-19, as well as with those with asymptomatic SARS-CoV-2.
Arm/Group Title Phases 1,2, & 3 Cohort 1 Symptomatic (Placebo) Phases 3 Cohort 1 Symptomatic (1.2g IV) Phases 1, 2, & 3 Cohort 1 Symptomatic (2.4g IV) Phases 1,2, & 3 Cohort 1 Symptomatic (8.0g IV)
Hide Arm/Group Description:
Pooled analysis of Phases 1, 2, & 3 Cohort 1 Symptomatic Participants for Placebo
Phase 3 Cohort 1 Symptomatic Participants for dosage of 1.2g IV
Pooled analysis of Phases 1, 2, & 3 Cohort 1 Symptomatic Participants for dosage of 2.4g IV
Pooled analysis of Phases 1, 2, & 3 Cohort 1 Symptomatic Participants for dosage of 8.0g IV
Overall Number of Participants Analyzed 2609 1935 3087 1272
Measure Type: Number
Unit of Measure: Participants
17 29 20 1
24.Secondary Outcome
Title Immunogenicity as Measured by Anti-drug (ADA) to REGN10933 (Ph3 Cohort 2 - Cohort 3)
Hide Description Symptomatic Participants Phase 3 Cohort 2 Participants Phase 3 Cohort 3 Participants
Time Frame Through Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
The anti-drug antibody (ADA) analysis set (AAS) includes all subjects who received any study drug (safety population) and had at least one non-missing ADA result from the ADA assay after first dose of the study drug(s). Participants will be analyzed according to the treatment actually received. This is an adaptive master protocol design, to allow for flexible adaptation for participants with symptomatic COVID-19, as well as with those with asymptomatic SARS-CoV-2.
Arm/Group Title Phase 3 Cohort 2 (Placebo) Phase 3 Cohort 2 (1.2g IV) Phase 3 Cohort 2 (2.4g IV) Phase 3 Cohort 3 (Placebo) Phase 3 Cohort 3 (1.2g IV) Phase 3 Cohort 3 (2.4g IV)
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Phase 3 Cohort 2 (Placebo) - ADA Analysis Set
Phase 3 Cohort 2 (1.2g IV) - ADA Analysis Set
Phase 3 Cohort 2 (2.4g IV) - ADA Analysis Set
Phase 3 Cohort 3 (Placebo) - ADA Analysis Set
Phase 3 Cohort 3 (1.2g IV) - ADA Analysis Set
Phase 3 Cohort 3 (2.4g IV) - ADA Analysis Set
Overall Number of Participants Analyzed 1 123 64 1 39 33
Measure Type: Number
Unit of Measure: Participants
0 1 0 0 0 1
25.Secondary Outcome
Title Immunogenicity as Measured by ADA to REGN10987 (Ph1 Cohort 1, Ph2 Cohort 1, Ph3 Cohort 1)
Hide Description Phase 1, Phase 2, Phase 3 (Cohort 1) - Pooled Symptomatic Participants
Time Frame Through Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
The anti-drug antibody (ADA) analysis set (AAS) includes all subjects who received any study drug (safety population) and had at least one non-missing ADA result from the ADA assay after first dose of the study drug(s). Pooled participants will be analyzed according to the treatment actually received. This is an adaptive master protocol design, to allow for flexible adaptation for participants with symptomatic COVID-19, as well as with those with asymptomatic SARS-CoV-2.
Arm/Group Title Pooled Phases 1,2, & 3 Cohort 1 Symptomatic (Placebo) Phase 3 Cohort 1 Symptomatic (1.2g IV) Pooled Phases 1, 2, & 3 Cohort 1 Symptomatic (2.4g IV) Pooled Phases 1,2, & 3 Cohort 1 Symptomatic (8.0g IV)
Hide Arm/Group Description:
Pooled analysis of Phases 1, 2, & 3 Cohort 1 Symptomatic Participants for Placebo
Phases 3 Cohort 1 Symptomatic Participants for dosage of 1.2g IV
Pooled analysis of Phases 1, 2, & 3 Cohort 1 Symptomatic Participants for dosage of 2.4g IV
Pooled analysis of Phases 1, 2, & 3 Cohort 1 Symptomatic Participants for dosage of 8.0g IV
Overall Number of Participants Analyzed 2609 1934 3084 1272
Measure Type: Number
Unit of Measure: Participants
59 56 54 2
26.Secondary Outcome
Title Immunogenicity as Measured by ADA to REGN10987 (Ph3 Cohort 2 and Cohort 3)
Hide Description Symptomatic Participants Phase 3 Cohort 2 Participants Phase 3 Cohort 3 Participants
Time Frame Through Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
The anti-drug antibody (ADA) analysis set (AAS) includes all subjects who received any study drug (safety population) and had at least one non-missing ADA result from the ADA assay after first dose of the study drug(s). Participants will be analyzed according to the treatment actually received. This is an adaptive master protocol design, to allow for flexible adaptation for participants with symptomatic COVID-19, as well as with those with asymptomatic SARS-CoV-2.
Arm/Group Title Phase 3 Cohort 2 (Placebo) Phase 3 Cohort 2 (1.2g IV) Phase 3 Cohort 2 (2.4g IV) Phase 3 Cohort 3 (Placebo) Phase 3 Cohort 3 (1.2g IV) Phase 3 Cohort 3 (2.4g IV)
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Phase 3 Cohort 2 Pediatric (Placebo)
Phase 3 Cohort 2 Pediatric (1.2g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
Phase 3 Cohort 3 Pregnant (Placebo)
Phase 3 Cohort 3 Pregnant (1.2g IV)
Phase 3 Cohort 3 Pregnant (2.4g IV)
Overall Number of Participants Analyzed 1 123 64 1 39 33
Measure Type: Number
Unit of Measure: Participants
0 1 0 0 2 1
27.Secondary Outcome
Title Immunogenicity as Measured by Neutralizing Antibodies (NAbs) to REGN10933 (Ph3 Cohort 2, Ph3 Cohort 3)
Hide Description

Symptomatic Participants Phase 3 Cohort 2 Participants Phase 3 Cohort 3 Participants

(TE&TB+;NAb+) = TE = Treatment-emergent; TB = Treatment-boosted; NAb+ = Positive in NAb assay
Time Frame Through Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
The anti-drug antibody (ADA) analysis set (AAS) includes all subjects who received any study drug (safety population) and had at least one non-missing ADA result from the ADA assay after first dose of the study drug(s). Participants will be analyzed according to the treatment actually received. This is an adaptive master protocol design, to allow for flexible adaptation for participants with symptomatic COVID-19, as well as with those with asymptomatic SARS-CoV-2.
Arm/Group Title Phase 3 Cohort 2 (Placebo) Phase 3 Cohort 2 (1.2g IV) Phase 3 Cohort 2 (2.4g IV) Phase 3 Cohort 3 (Placebo) Phase 3 Cohort 3 (1.2g IV) Phase 3 Cohort 3 (2.4g IV)
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Phase 3 Cohort 2 Pediatric (Placebo)
Phase 3 Cohort 2 Pediatric (1.2g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
Phase 3 Cohort 3 Pregnant (Placebo)
Phase 3 Cohort 3 Pregnant (1.2g IV)
Phase 3 Cohort 3 Pregnant (2.4g IV)
Overall Number of Participants Analyzed 1 123 64 1 39 33
Measure Type: Number
Unit of Measure: Participants
0 0 0 0 0 0
28.Secondary Outcome
Title Immunogenicity as Measured by NAbs to REGN10987 (Ph3 Cohort 2 - Cohort 3)
Hide Description

Phase 3 Cohort 2 Participants Phase 3 Cohort 3 Participants

(TE&TB+;NAb+) = TE = Treatment-emergent; TB = Treatment-boosted; NAb+ = Positive in NAb assay
Time Frame Through Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
The anti-drug antibody (ADA) analysis set (AAS) includes all subjects who received any study drug (safety population) and had at least one non-missing ADA result from the ADA assay after first dose of the study drug(s). Participants will be analyzed according to the treatment actually received.
Arm/Group Title Phase 3 Cohort 2 (Placebo) Phase 3 Cohort 2 (1.2g IV) Phase 3 Cohort 2 (2.4g IV) Phase 3 Cohort 3 (Placebo) Phase 3 Cohort 3 (1.2g IV) Phase 3 Cohort 3 (2.4g IV)
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Phase 3 Cohort 2 Pediatric (Placebo)
Phase 3 Cohort 2 Pediatric (1.2g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
Phase 3 Cohort 3 Pregnant (Placebo)
Phase 3 Cohort 3 Pregnant (1.2g IV)
Phase 3 Cohort 3 Pregnant (2.4g IV)
Overall Number of Participants Analyzed 1 123 64 1 39 33
Measure Type: Number
Unit of Measure: Participants
0 1 0 00 0 0
29.Secondary Outcome
Title Number of Participants With at Least One (≥1) COVID-19-related Hospitalization or All-cause Death (Phase 3 Cohort 2)
Hide Description Phase 3 (Cohort 2)
Time Frame Through Day 29
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Hide Analysis Population Description
Participants <18 years old who, at baseline, were not pregnant, had symptomatic COVID-19, and had at least 1 risk factor for developing severe disease
Arm/Group Title Phase 3 Cohort 2 Pediatric (Placebo) Phase 3 Cohort 2 Pediatric (1.2g IV) Phase 3 Cohort 2 Pediatric (2.4g IV)
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Phase 3 Cohort 2 Pediatric (Placebo)
Phase 3 Cohort 2 Pediatric (1.2g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
Overall Number of Participants Analyzed 1 121 70
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
30.Secondary Outcome
Title Percentage of Participants With ≥1 COVID-19-related Medically-attended Visit (Phase 1, Phase 2)
Hide Description Phase 1, Phase 2 Medically-attended Visits include Hospitalizations, ER visits, Urgent Care Clinic visits, Outpatient/physician office/telemedicine visits
Time Frame Through Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants in Phase 1 or Phase 2 with qualitatively positive RT-qPCR in NP swab samples at randomization or collected within 2 hours after study drug infusion was initiated. This modified full analysis set (mFAS) includes all randomized patients with positive RT-qPCR in NP swab samples at randomization and is based on the treatment allocated (as randomized).
Arm/Group Title Phase 1 + Phase 2 Symptomatic (Placebo) Phase 1 + Phase 2 Symptomatic (2.4g IV) Phase 1 + Phase 2 Symptomatic (8.0g IV)
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Pooled Phase 1 + Phase 2 Symptomatic Placebo Participants
Pooled Phase 1 + Phase 2 Symptomatic 2.4g IV Participants
Pooled Phase 1 + Phase 2 Symptomatic 8.0g IV Participants
Overall Number of Participants Analyzed 232 219 220
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
7.8
(4.7 to 12.0)
3.2
(1.3 to 6.5)
2.7
(1.0 to 5.8)
31.Secondary Outcome
Title Percentage of Participants With ≥2 COVID-19-related Medically-attended Visit - (Ph3 Cohort 1) - Placebo vs. 1.2g IV
Hide Description Phase 3 (Cohort 1)
Time Frame Through Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Arm/Group Title Phase 3 Cohort 1 (Placebo) Phase 3 Cohort 1 (1.2g IV) >=18
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Phase 3 Cohort 1 (Placebo) Participants
Phase 3 Cohort 1 (1.2g IV) Participants
Overall Number of Participants Analyzed 748 736
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
0.5
(0.1 to 1.4)
0.4
(0.1 to 1.2)
32.Secondary Outcome
Title Percentage of Participants With ≥2 COVID-19-related Medically-attended Visit - (Ph3 Cohort 1) - Placebo vs. 2.4g IV
Hide Description Phase 3 Cohort 1
Time Frame Through Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Arm/Group Title Phase 3 Cohort 1 (Placebo) Phase 3 Cohort 1 (2.4g IV) >=18
Hide Arm/Group Description:
Phase 3 Cohort 1 (Placebo) Participants
Phase 3 Cohort 1 (2.4g IV) Participants
Overall Number of Participants Analyzed 1341 1355
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
1.1
(0.6 to 1.8)
0.07
(0.0 to 0.4)
33.Secondary Outcome
Title Total Number of COVID-19-related Medically-attended Visits (Phase 1 and Phase 2)
Hide Description Phase 1 and Phase 2
Time Frame Through Day 29
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Hide Analysis Population Description
Analysis populations were prespecified in the SAP. Pooled analyses were performed for symptomatic adult participants randomized in Phase 1, 2, or 3 (cohort 1) on or before 2/24/21 to placebo, R10933+R10987 1.2 g, 2.4 g, or 8.0 g IV. No phase 1 or 2 participants were randomized to R10933+R10987 1.2 g IV. Asymptomatic adult participants randomized to the asymptomatic cohort of phase 2, symptomatic pediatric / pregnant participants randomized in phase 3 to cohort 2 or 3 were analyzed separately.
Arm/Group Title Phase 1 + Phase 2 Symptomatic Phase 1 + Phase 2 Symptomatic 2.4g IV Phase 1 + Phase 2 Symptomatic 8.0g IV mFAS (Modified Full Analysis Set)
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Pooled Phase 1 + Phase 2 Symptomatic Participants mFAS (modified Full Analysis Set)
Pooled Phase 1 + Phase 2 Symptomatic 2.4g IV mFAS (modified Full Analysis Set)
Pooled Phase 1 + Phase 2 Symptomatic 8.0g IV mFAS (modified Full Analysis Set)
Overall Number of Participants Analyzed 232 219 220
Measure Type: Number
Unit of Measure: Number of Participants
18 7 6
34.Secondary Outcome
Title Assessment of Pharmacokinetic (PK) Parameter: Maximum Serum Concentration Observed (Cmax) of REGN10933 and REGN10987 (Phase 1 Only)
Hide Description Phase 1 Only
Time Frame Through Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetics (PK) analysis pooled population includes all patients who received any study drug (safety population) and who had at least 1 non-missing result following the first dose of study drug
Arm/Group Title Phase 1 PK-AS (Pharmacokinetic Analysis Analysis Set)
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PK-AS of participants in Phase 1 Adult Symptomatic Participants with COVID-19
Overall Number of Participants Analyzed 45
Mean (Standard Deviation)
Unit of Measure: mg/L (milligram/Liters)
REGN10933 Number Analyzed 22 participants
343  (160)
REGN10987 Number Analyzed 22 participants
353  (233)
35.Secondary Outcome
Title Assessment of PK Parameter: Cmax-to-dose Ratio (Cmax/Dose) of REGN10933 and REGN10987 (Phase 1 Only)
Hide Description Phase 1 Only
Time Frame Though Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetics (PK) analysis population includes all patients who received any study drug (safety population) and who had at least 1 non-missing result following the first dose of study drug
Arm/Group Title Phase 1 PK-AS (Pharmacokinetic Analysis Analysis Set)
Hide Arm/Group Description:
PK-AS of participants in Phase 1 Adult Symptomatic Participants with COVID-19
Overall Number of Participants Analyzed 45
Mean (Standard Deviation)
Unit of Measure: mg/L/mg (milligram/Liter/milligram)
REGN10933 Number Analyzed 22 participants
0.286  (0.134)
REGN10987 Number Analyzed 22 participants
0.294  (0.194)
36.Secondary Outcome
Title Assessment of PK Parameter: Time to Cmax (Tmax) for REGN10933 and REGN10987 (Phase 1 Only)
Hide Description Phase 1 Only
Time Frame Through Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetics (PK) analysis population includes all patients who received any study drug (safety population) and who had at least 1 non-missing result following the first dose of study drug
Arm/Group Title Phase 1 PK-AS (Pharmacokinetic Analysis Analysis Set)
Hide Arm/Group Description:
PK-AS of participants in Phase 1 Adult Symptomatic Participants with COVID-19
Overall Number of Participants Analyzed 45
Median (Full Range)
Unit of Measure: Day
REGN10933 Number Analyzed 22 participants
0.0861
(0 to 14.9)
REGN10987 Number Analyzed 22 participants
0.0861
(0 to 14.9)
37.Secondary Outcome
Title Assessment of PK Parameter: Area Under the Curve (AUC) Computed From Time Zero to the Time of the Last Positive Concentration (AUClast) for REGN10933 - (Phase 1 Only)
Hide Description Phase 1 Only - Tlast (Time of last quantifiable concentration)
Time Frame Through Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetics (PK) analysis population includes all patients who received any study drug (safety population) and who had at least 1 non-missing result following the first dose of study drug
Arm/Group Title Phase 1 PK-AS (Pharmacokinetic Analysis Set)
Hide Arm/Group Description:
PK-AS of participants in Phase 1 Adult Symptomatic Participants with COVID-19
Overall Number of Participants Analyzed 22
Median (Full Range)
Unit of Measure: ((day*mg/L)/mg)
REGN10933
27.7
(0.0847 to 28.2)
REGN10987
27.7
(13.0 to 28.2)
38.Secondary Outcome
Title Proportion of Participants With at Least One (≥1) COVID-19-related Hospitalization or All-cause Death From Day 4 Through Day 29 (Ph3 Cohort 1- 1.2g vs Placebo)
Hide Description Phase 3 Cohort 1
Time Frame Day 4 Through Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Arm/Group Title Phase 3 Cohort 1 (Placebo) >=18 Phase 3 Cohort 1 (1.2g IV) >= 18
Hide Arm/Group Description:
Phase 3 Cohort 1 (Placebo)
Phase 3 Cohort 1 (1.2g IV)
Overall Number of Participants Analyzed 748 736
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
2.4
(1.4 to 3.8)
0.7
(0.2 to 1.6)
39.Secondary Outcome
Title Proportion of Participants With at Least One (≥1) COVID-19-related Hospitalization or All-cause Death From Day 4 Through Day 29 (Ph3 Cohort 1- 2.4g vs Placebo)
Hide Description Phase 3 Cohort 1
Time Frame Day 4 Through Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Arm/Group Title Phase 3 Cohort 1 (Placebo) >=18 Phase 3 Cohort 1 (2.4g IV) >= 18
Hide Arm/Group Description:
Phase 3 Cohort 1 (Placebo)
Phase 3 Cohort 1 (2.4g IV)
Overall Number of Participants Analyzed 1340 1351
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
3.4
(2.5 to 4.6)
0.4
(0.1 to 0.9)
40.Secondary Outcome
Title Proportion of Participants With at Least One (≥1) COVID-19-related Medically-attended Visit or All-cause Death Through Day 29 (Ph3 Cohort 1- 1.2g vs Placebo)
Hide Description Phase 3 Cohort 1
Time Frame Through Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Arm/Group Title Phase 3 Cohort 1 (Placebo) >=18 Phase 3 Cohort 1 (1.2g IV) >= 18
Hide Arm/Group Description:
Phase 3 Cohort 1 (Placebo)
Phase 3 Cohort 1 (1.2g IV)
Overall Number of Participants Analyzed 748 736
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
6.8
(5.1 to 8.9)
2.7
(1.7 to 4.2)
41.Secondary Outcome
Title Proportion of Participants With at Least One (≥1) COVID-19-related Medically-attended Visit or All-cause Death Through Day 29 (Ph3 Cohort 1- 2.4g vs Placebo)
Hide Description Phase 3 Cohort 1
Time Frame Through Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Arm/Group Title Phase 3 Cohort 1 (Placebo) >=18 Phase 3 Cohort 1 (2.4g IV) >= 18
Hide Arm/Group Description:
Phase 3 Cohort 1 (Placebo)
Phase 3 Cohort 1 (2.4g IV)
Overall Number of Participants Analyzed 1341 1355
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
8.1
(6.7 to 9.7)
3.2
(2.3 to 4.3)
42.Secondary Outcome
Title Number of Participants With at Least One (≥1) COVID-19-related Medically-attended Visit or All-cause Death Through Day 29 (Phase 3 Cohort 2)
Hide Description Phase 3 (Cohort 2)
Time Frame Through Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Participants <18 years old who, at baseline, were not pregnant, had symptomatic COVID-19, and had at least 1 risk factor for developing severe disease
Arm/Group Title Phase 3 Cohort 2 Pediatric (Placebo) Phase 3 Cohort 2 Pediatric (1.2g IV) Phase 3 Cohort 2 Pediatric (2.4g IV)
Hide Arm/Group Description:
Phase 3 Cohort 2 Pediatric (Placebo)
Phase 3 Cohort 2 Pediatric (1.2g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
Overall Number of Participants Analyzed 1 121 70
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
2
   1.7%
1
   1.4%
43.Secondary Outcome
Title Proportion of Participants With at Least One (≥1) COVID-19-related Medically-attended Visit by Type of Visit Through Day 29 (Ph3 Cohort 1- 1.2g vs Placebo)
Hide Description Phase 3 Cohort 1
Time Frame Through Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Arm/Group Title Phase 3 Cohort 1 (Placebo) >=18 Phase 3 Cohort 1 (1.2g IV) >= 18
Hide Arm/Group Description:
Phase 3 Cohort 1 (Placebo)
Phase 3 Cohort 1 (1.2g IV)
Overall Number of Participants Analyzed 748 736
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
Hospitalization
3.1
(2.0 to 4.6)
0.8
(0.3 to 1.8)
Emergency Room
1.3
(0.6 to 2.4)
0.3
(0.0 to 1.0)
Urgent Care
0.7
(0.2 to 1.6)
0.1
(0.0 to 0.8)
Physician office visit/Telemedicine
1.6
(0.8 to 2.8)
1.4
(0.7 to 2.5)
44.Secondary Outcome
Title Proportion of Participants With at Least One (≥1) COVID-19-related Medically-attended Visit by Type of Visit Through Day 29 (Ph3 Cohort 1- 2.4g vs Placebo)
Hide Description Phase 3 Cohort 1
Time Frame Through Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Arm/Group Title Phase 3 Cohort 1 (Placebo) >=18 Phase 3 Cohort 1 (2.4g IV) >= 18
Hide Arm/Group Description:
Phase 3 Cohort 1 (Placebo)
Phase 3 Cohort 1 (2.4g IV)
Overall Number of Participants Analyzed 1341 1355
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
Hospitalization
4.4
(3.4 to 5.6)
1.3
(0.7 to 2.0)
Emergency Room
1.2
(0.7 to 1.9)
0.7
(0.3 to 1.3)
Urgent Care
0.5
(0.2 to 1.1)
0.2
(0.0 to 0.6)
Physician office visit/Telemedicine
1.8
(1.1 to 2.7)
1.0
(0.5 to 1.6)
45.Secondary Outcome
Title Total Number of COVID-19-related Medically-attended Visits by Type of Visit Through Day 29 (Phase 3 Cohort 2)
Hide Description Phase 3 (Cohort 2)
Time Frame Through Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Participants <18 years old who, at baseline, were not pregnant, had symptomatic COVID-19, and had at least 1 risk factor for developing severe disease
Arm/Group Title Phase 3 Cohort 2 Pediatric (Placebo) Phase 3 Cohort 2 Pediatric (1.2g IV) Phase 3 Cohort 2 Pediatric (2.4g IV)
Hide Arm/Group Description:
Phase 3 Cohort 2 Pediatric (Placebo)
Phase 3 Cohort 2 Pediatric (1.2g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
Overall Number of Participants Analyzed 1 121 70
Measure Type: Number
Unit of Measure: Medically-Attended Visit
Emergency Room 0 1 0
Outpatient/Telemedicine 0 1 1
46.Secondary Outcome
Title Cumulative Incidence Percentage of Patients With COVID-19-related Hospitalization or All-cause Death Through Day 29 (Ph3 Cohort 1- 1.2g vs Placebo)
Hide Description Phase 3 Cohort 1
Time Frame Through Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Arm/Group Title Phase 3 Cohort 1 (Placebo) >=18 Phase 3 Cohort 1 (1.2g IV) >= 18
Hide Arm/Group Description:
Phase 3 Cohort 1 (Placebo)
Phase 3 Cohort 1 (1.2g IV)
Overall Number of Participants Analyzed 748 736
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Cumulative Incidence Percentage
3.2
(2.2 to 4.8)
1.0
(0.5 to 2.0)
47.Secondary Outcome
Title Cumulative Incidence Percentage of Patients With COVID-19-related Hospitalization or All-cause Death Through Day 29 (Ph3 Cohort 1- 2.4g vs Placebo)
Hide Description Phase 3 Cohort 1
Time Frame Through Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Arm/Group Title Phase 3 Cohort 1 (Placebo) >=18 Phase 3 Cohort 1 (2.4g IV) >= 18
Hide Arm/Group Description:
Phase 3 Cohort 1 (Placebo)
Phase 3 Cohort 1 (2.4g IV)
Overall Number of Participants Analyzed 1341 1355
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Cumulative Incidence Percentage
4.6
(3.6 to 5.9)
1.3
(0.8 to 2.1)
48.Secondary Outcome
Title Cumulative Incidence Percentage of Patients With COVID-19-related Hospitalization, Emergency Room (ER) or All-cause Death Through Day 29 (Ph3 Cohort 1- 1.2g vs Placebo)
Hide Description Phase 3 Cohort 1
Time Frame Through Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Arm/Group Title Phase 3 Cohort 1 (Placebo) >=18 Phase 3 Cohort 1 (1.2g IV) >= 18
Hide Arm/Group Description:
Phase 3 Cohort 1 (Placebo)
Phase 3 Cohort 1 (1.2g IV)
Overall Number of Participants Analyzed 748 736
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Cumulative Incidence Percentage
4.6
(3.3 to 6.3)
1.2
(0.6 to 2.4)
49.Secondary Outcome
Title Cumulative Incidence Percentage of Patients With COVID-19-related Hospitalization, Emergency Room (ER) or All-cause Death Through Day 29 (Ph3 Cohort 1- 2.4g vs Placebo)
Hide Description Phase 3 Cohort 1
Time Frame Through Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Arm/Group Title Phase 3 Cohort 1 (Placebo) >=18 Phase 3 Cohort 1 (2.4g IV) >= 18
Hide Arm/Group Description:
Phase 3 Cohort 1 (Placebo)
Phase 3 Cohort 1 (2.4g IV)
Overall Number of Participants Analyzed 1341 1355
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Cumulative Incidence Percentage
5.8
(4.7 to 7.2)
2.0
(1.4 to 2.9)
50.Secondary Outcome
Title Cumulative Incidence Percentage of Patients With COVID-19-related Medically-attended Visit or All-cause Death Through Day 29 (Ph3 Cohort 1- 1.2g vs Placebo)
Hide Description Phase 3 Cohort 1
Time Frame Through Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Arm/Group Title Phase 3 Cohort 1 (Placebo) >=18 Phase 3 Cohort 1 (1.2g IV) >= 18
Hide Arm/Group Description:
Phase 3 Cohort 1 (Placebo)
Phase 3 Cohort 1 (1.2g IV)
Overall Number of Participants Analyzed 748 736
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Cumulative Incidence Percentage
6.9
(5.2 to 8.9)
2.7
(1.8 to 4.2)
51.Secondary Outcome
Title Cumulative Incidence Percentage of Patients With COVID-19-related Medically-attended Visit or All-cause Death Through Day 29 (Ph3 Cohort 1- 2.4g vs Placebo)
Hide Description Phase 3 Cohort 1
Time Frame Through Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Arm/Group Title Phase 3 Cohort 1 (Placebo) >=18 Phase 3 Cohort 1 (2.4g IV) >= 18
Hide Arm/Group Description:
Phase 3 Cohort 1 (Placebo)
Phase 3 Cohort 1 (2.4g IV)
Overall Number of Participants Analyzed 1341 1355
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Cumulative Incidence Percentage
8.2
(6.8 to 9.8)
3.2
(2.4 to 4.3)
52.Secondary Outcome
Title Proportion of Participants Requiring Supplemental Oxygen Due to COVID-19 by Day 29 (Ph3 Cohort 1- 1.2g vs Placebo)
Hide Description Phase 3 Cohort 1
Time Frame Through Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Arm/Group Title Phase 3 Cohort 1 (Placebo) >=18 Phase 3 Cohort 1 (1.2g IV) >= 18
Hide Arm/Group Description:
Phase 3 Cohort 1 (Placebo)
Phase 3 Cohort 1 (1.2g IV)
Overall Number of Participants Analyzed 748 736
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
2.1
(1.2 to 3.5)
0.5
(0.1 to 1.4)
53.Secondary Outcome
Title Proportion of Participants Requiring Supplemental Oxygen Due to COVID-19 by Day 29 (Ph3 Cohort 1- 2.4g vs Placebo)
Hide Description Phase 3 Cohort 1
Time Frame Through Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Arm/Group Title Phase 3 Cohort 1 (Placebo) >=18 Phase 3 Cohort 1 (2.4g IV) >= 18
Hide Arm/Group Description:
Phase 3 Cohort 1 (Placebo)
Phase 3 Cohort 1 (2.4g IV)
Overall Number of Participants Analyzed 1341 1355
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
3.6
(2.7 to 4.7)
1.0
(0.5 to 1.6)
54.Secondary Outcome
Title Percentage of Participants With All-Cause Death (Ph3 Cohort 1) Placebo vs. 1.2g
Hide Description Phase 3 Cohort 1
Time Frame by Day 29, Day 120, and Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Arm/Group Title Phase 3 Cohort 1 (Placebo) >=18 Phase 3 Cohort 1 (1.2g IV) >= 18
Hide Arm/Group Description:
Phase 3 Cohort 1 (Placebo)
Phase 3 Cohort 1 (1.2g IV)
Overall Number of Participants Analyzed 748 736
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
by Day 29
0.1
(0.0 to 0.7)
0.1
(0.0 to 0.8)
by Day 120
0.1
(0.0 to 0.7)
0.1
(0.0 to 0.8)
by Day 169
0.1
(0.0 to 0.7)
0.1
(0.0 to 0.8)
55.Secondary Outcome
Title Percentage of Participants With All-Cause Death (Ph3 Cohort 1) Placebo vs. 2.4g
Hide Description Phase 3 Cohort 1 Placebo vs. 2.4g IV
Time Frame by Day 29, Day 120, and Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Arm/Group Title Phase 3 Cohort 1 (Placebo) >=18 Phase 3 Cohort 1 (2.4g IV) >= 18
Hide Arm/Group Description:
Phase 3 Cohort 1 (Placebo)
Phase 3 Cohort 1 (2.4g IV)
Overall Number of Participants Analyzed 1341 1355
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
by Day 29
0.2
(0.0 to 0.7)
0.07
(0.0 to 0.4)
by Day 120
0.4
(0.1 to 0.9)
0.07
(0.0 to 0.4)
by Day 169
0.1
(0.1 to 0.9)
0.07
(0.0 to 0.4)
56.Secondary Outcome
Title Proportion of Participants With High Viral Load at Each Visit - (Phase 2 Only)
Hide Description Next Phase 2 Only
Time Frame Through Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
In light of evolving information concerning SARS-CoV-2 infection, including the profile of viral load among patients and the adequacy of sampling methodologies, virologic efficacy endpoints and sampling methods were modified during the course of the study.
Arm/Group Title Placebo R10933+R10987 2.4 g IV R10933+R10987 8.0 g IV
Hide Arm/Group Description:
Placebo Phase 2 Participants
R10933+R10987 2.4 g IV
R10933+R10987 8.0 g IV
Overall Number of Participants Analyzed 150 142 145
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
Day 3 Number Analyzed 136 participants 132 participants 135 participants
77.2
(69.2 to 84.0)
67.4
(58.7 to 75.3)
62.2
(53.5 to 70.4)
Day 5 Number Analyzed 140 participants 134 participants 136 participants
61.4
(52.8 to 69.5)
47.0
(38.3 to 55.8)
44.1
(35.6 to 52.9)
Day 7 Number Analyzed 139 participants 131 participants 132 participants
48.9
(40.4 to 57.5)
31.3
(23.5 to 40.0)
28.8
(21.2 to 37.2)
Day 15 Number Analyzed 100 participants 98 participants 95 participants
10.0
(4.9 to 17.6)
5.1
(1.7 to 11.5)
4.2
(1.2 to 10.4)
Day 29 Number Analyzed 53 participants 49 participants 55 participants
0
(0 to 0)
2.0
(0.1 to 10.9)
1.8
(0.0 to 9.7)
57.Secondary Outcome
Title Correlation of RT-qPCR Results Over Time Between Different Sample Types (NP, Nasal, and Saliva) - (Phase 1 Only)
Hide Description Phase 1 Only
Time Frame Up to Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Nasal and saliva sample collection was discontinued early in the study because nasopharyngeal samples were determined to be more reliable for quantitative analysis. Therefore, data was not collected for this outcome measure. The Phase 1/2 SAP does not specify any analyses related to nasal and saliva samples collections
Arm/Group Title Phase 1 Only
Hide Arm/Group Description:
Phase 1 Only Participants
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
58.Secondary Outcome
Title Change From Baseline in Viral Load at Each Visit, as Measured by RT-qPCR in Nasal Swabs - (Phase 1 Only)
Hide Description Phase 1 Only
Time Frame Baseline Up To Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Nasal and saliva sample collection was discontinued early in the study because nasopharyngeal samples were determined to be more reliable for quantitative analysis. Therefore, data was not collected for this outcome measure. The Phase 1/2 SAP does not specify any analyses related to nasal and saliva samples collections
Arm/Group Title Phase 1 Only
Hide Arm/Group Description:
Phase 1 Participants
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
59.Secondary Outcome
Title Change From Baseline in Viral Load at Each Visit, as Measured by RT-qPCR in Saliva Samples - (Phase 1 Only)
Hide Description Phase 1 Only
Time Frame Baseline Up to Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Nasal and saliva sample collection was discontinued early in the study because nasopharyngeal samples were determined to be more reliable for quantitative analysis. Therefore, data was not collected for this outcome measure. The Phase 1/2 SAP does not specify any analyses related to nasal and saliva samples collections
Arm/Group Title Phase 1
Hide Arm/Group Description:
Adult Symptomatic Participants with COVID-19
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
60.Secondary Outcome
Title Concordance of RT-qPCR Results Over Time Between Different Sample Types (NP, Nasal, and Saliva) - (Phase 1 Only)
Hide Description Phase 1 Only
Time Frame Up To Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Nasal and saliva sample collection was discontinued early in the study because nasopharyngeal samples were determined to be more reliable for quantitative analysis. Therefore, data was not collected for this outcome measure. The Phase 1/2 SAP does not specify any analyses related to nasal and saliva samples collections
Arm/Group Title Phase 1 Only
Hide Arm/Group Description:
Phase 1 Participants Only
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
61.Secondary Outcome
Title Time-weighted Average Change From Baseline in Viral Load (log10 Copies/mL), as Measured by RT-qPCR in Saliva Samples - (Phase 1)
Hide Description Phase 1 Only
Time Frame Baseline up to Day 22
Hide Outcome Measure Data
Hide Analysis Population Description
In light of evolving information concerning SARS-CoV-2 infection, including the profile of viral load among patients and the adequacy of sampling methodologies, virologic efficacy endpoints and sampling methods were modified during the course of the study
Arm/Group Title Phase 1
Hide Arm/Group Description:
Phase 1 Participants
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
62.Secondary Outcome
Title Number of Participants With Viral Loads Below the Limit of Detection at Each Visit - (Phase 2 Only)
Hide Description Phase 2 Only
Time Frame Through Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
In light of evolving information concerning SARS-CoV-2 infection, including the profile of viral load among patients and the adequacy of sampling methodologies, virologic efficacy endpoints and sampling methods were modified during the course of the study
Arm/Group Title Phase 2 Only (Placebo) Phase 2 (2.4g IV) Participants Phase 2 (8.0g IV) Participants
Hide Arm/Group Description:
Phase 2 (Placebo) Asymptomatic Participants
Phase 2 (2.4 g IV) Asymptomatic Participants of modified Full Analysis Set (mFAS)
Phase 2 (8.0g IV) Asymptomatic Participants of modified Full Analysis Set (mFAS)
Overall Number of Participants Analyzed 57 49 51
Measure Type: Number
Unit of Measure: Number of Participants
Day 0 (Baseline) Number Analyzed 57 participants 49 participants 51 participants
0 0 0
Day 5 Number Analyzed 54 participants 45 participants 47 participants
14 15 10
Day 7 Number Analyzed 55 participants 48 participants 48 participants
18 22 14
Day 15 Number Analyzed 56 participants 47 participants 50 participants
36 39 32
Day 29 Number Analyzed 54 participants 46 participants 46 participants
48 44 36
63.Secondary Outcome
Title Duration of Symptoms Consistent With COVID-19 (Phase 2 Only)
Hide Description Phase 2 Only
Time Frame Through Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were part of Phase 2 Asymptomatic modified Full Analysis Set (mFAS)
Arm/Group Title Phase 2 Placebo Phase 2 (2.4 g IV) Participants Phase 2 (8.0g IV) Participants
Hide Arm/Group Description:
Phase 2 (Placebo) Asymptomatic Participants
Phase 2 (2.4 g IV) Asymptomatic Participants of modified Full Analysis Set (mFAS)
Phase 2 (8.0g IV) Asymptomatic Participants of modified Full Analysis Set (mFAS)
Overall Number of Participants Analyzed 22 14 17
Mean (Standard Deviation)
Unit of Measure: Days
12.6  (9.27) 13.1  (9.34) 14.4  (10.95)
64.Secondary Outcome
Title Time to First Onset of Symptoms Consistent With COVID-19 (Phase 2 Asymptomatic Cohort Only)
Hide Description Phase 2 Only
Time Frame Through Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Phase 2 asymptomatic cohort
Arm/Group Title Phase 2 Only Phase 2 2.4g IV Phase 2 8.0g IV
Hide Arm/Group Description:
Phase 2 Participants
Phase 2 asymptomatic participants
Phase 2 asymptomatic participants 8.0g IV
Overall Number of Participants Analyzed 57 49 51
Median (Full Range)
Unit of Measure: Days
3.0
(1.0 to 9.0)
2.5 [1] 
(1.0 to NA)
4.0 [1] 
(2.0 to NA)
[1]
Inadequate number of events to reach upper limit
65.Secondary Outcome
Title Number of Participants Admitted to a Hospital Due to COVID-19 (Phase 1, Phase 2)
Hide Description Phase 1, Phase 2
Time Frame Through Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
All pooled randomized participants in Phase 1 or Phase 2 with qualitatively positive RT-qPCR in NP swab samples at randomization or collected within 2 hours after study drug infusion was initiated. This modified full analysis set (mFAS) includes all randomized patients with positive RT-qPCR in NP swab samples at randomization and is based on the treatment allocated (as randomized).
Arm/Group Title Phase 1 + Phase 2 Symptomatic (Placebo) Participants Phase 1 + Phase 2 Symptomatic (2.4g IV) Participants Phase 1 + Phase 2 Symptomatic (8.0g IV) Participants
Hide Arm/Group Description:
Pooled Phase 1 + Phase 2 Symptomatic Placebo Participants
Pooled Phase 1 + Phase 2 Symptomatic (2.4g IV) Participants
Pooled Phase 1 + Phase 2 Symptomatic (8.0g IV) Participants
Overall Number of Participants Analyzed 81 73 74
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Number Participants
1
(0.0 to 6.7)
0
(0 to 0)
0
(0 to 0)
66.Secondary Outcome
Title Time to Negative RT-qPCR in All Tested Samples With no Subsequent Positive RT-qPCR in Any Tested Samples - (Phase 1 Only)
Hide Description Phase 1 Only
Time Frame Through Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
In light of evolving information concerning SARS-CoV-2 infection, including the profile of viral load among patients and the adequacy of sampling methodologies, virologic efficacy endpoints and sampling methods were modified during the course of the study
Arm/Group Title Phase 1 Only
Hide Arm/Group Description:
Phase 1 Participants
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
67.Secondary Outcome
Title Proportion of Participants With All-cause Mortality (Phase 2 Asymptomatic)
Hide Description Phase 2 Asymptomatic
Time Frame Through Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Phase 2 asymptomatic cohort
Arm/Group Title Phase 2 Asymptomatic Placebo Phase 2 Asymptomatic R10933+R10987 2.4g IV Phase 2 Asymptomatic R10933+R10987 8.0g IV
Hide Arm/Group Description:
Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
Overall Number of Participants Analyzed 73 74 75
Measure Type: Number
Unit of Measure: Participants
0 0 0
68.Secondary Outcome
Title Time to All-cause Death (Ph3 Cohort 1- 1.2g vs Placebo)
Hide Description Phase 3 Cohort 1 (1.2g IV)
Time Frame Through Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Arm/Group Title Phase 3 Cohort 1 (Placebo) >= 18 Phase 3 Cohort 1 (1.2g IV) >= 18
Hide Arm/Group Description:
Phase 3 Cohort 1 Participants (Placebo)
Phase 3 Cohort 1 Participants (1.2g IV)
Overall Number of Participants Analyzed 748 736
Median (95% Confidence Interval)
Unit of Measure: Days
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
Unable to calculate due to too few events
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Phase 3 Cohort 1 (Placebo) >= 18, Phase 3 Cohort 1 (1.2g IV) >= 18
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.01
Confidence Interval (2-Sided) 95%
0.06 to 16.12
Estimation Comments [Not Specified]
69.Secondary Outcome
Title Time to All-cause Death (Ph3 Cohort 1- 2.4g vs Placebo)
Hide Description Phase 3 Cohort 1 (2.4g IV)
Time Frame Through Day 169
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Hide Analysis Population Description
Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Arm/Group Title Phase 3 Cohort 1 (Placebo) >= 18 Phase 3 Cohort 1 (2.4g IV) >= 18
Hide Arm/Group Description:
Phase 3 Cohort 1 Participants (Placebo)
Phase 3 Cohort 1 Participants (2.4g IV)
Overall Number of Participants Analyzed 1341 1355
Median (95% Confidence Interval)
Unit of Measure: Days
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
Unable to calculate due to too few events
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Phase 3 Cohort 1 (Placebo) >= 18, Phase 3 Cohort 1 (2.4g IV) >= 18
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.33
Confidence Interval (2-Sided) 95%
0.03 to 3.13
Estimation Comments [Not Specified]
70.Secondary Outcome
Title Time to All-cause Death (Phase 3 Cohort 2)
Hide Description Phase 3 (Cohort 2)
Time Frame Through Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
There were no deaths in this cohort. Phase 3 Cohort 2 data was not analyzed for this endpoint as there were no deaths.
Arm/Group Title Phase 3 Cohort 2 Pediatric (Placebo) Phase 3 Cohort 2 Pediatric (1.2g IV) Phase 3 Cohort 2 Pediatric (2.4g IV)
Hide Arm/Group Description:
Phase 3 Cohort 2 Pediatric (Placebo)
Phase 3 Cohort 2 Pediatric (1.2g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
Overall Number of Participants Analyzed 1 121 70
Measure Type: Number
Unit of Measure: Days
0 0 0
71.Secondary Outcome
Title Proportion of Participants Requiring Mechanical Ventilation Due to COVID-19 (Ph3 Cohort 1- 1.2g vs Placebo)
Hide Description [Not Specified]
Time Frame Through Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Arm/Group Title Phase 3 Cohort 1 (Placebo) >= 18 Phase 3 Cohort 1 (1.2g IV) >= 18
Hide Arm/Group Description:
Phase 3 Cohort 1 Participants (Placebo)
Phase 3 Cohort 1 Participants (1.2g IV)
Overall Number of Participants Analyzed 748 736
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
0.3
(0.0 to 1.0)
0.1
(0.0 to 0.8)
72.Secondary Outcome
Title Proportion of Participants Requiring Mechanical Ventilation Due to COVID-19 (Ph3 Cohort 1- 2.4g vs Placebo)
Hide Description [Not Specified]
Time Frame Through Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Arm/Group Title Phase 3 Cohort 1 (Placebo) Phase 3 Cohort 1 (2.4g IV) >= 18
Hide Arm/Group Description:
Phase 3 Cohort 1 Participants (Placebo)
Phase 3 Cohort 1 Participants (2.4g IV)
Overall Number of Participants Analyzed 1341 1355
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Proportion of Participants
0.4
(0.2 to 1.0)
0.0007
(0.0 to 0.4)
73.Secondary Outcome
Title Proportion of Participants Requiring Mechanical Ventilation Due to COVID-19 (Phase 3 Cohort 2)
Hide Description Phase 3 (Cohort 2)
Time Frame Through Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
There were 0 events in this endpoint. Phase 3 Cohort 2 data was not analyzed for this endpoint as there were 0 events in in this cohort
Arm/Group Title Phase 3 Cohort 2 Pediatric (Placebo) Phase 3 Cohort 2 Pediatric (1.2g IV) Phase 3 Cohort 2 Pediatric (2.4g IV)
Hide Arm/Group Description:
Phase 3 Cohort 2 Pediatric (Placebo)
Phase 3 Cohort 2 Pediatric (1.2g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
Overall Number of Participants Analyzed 1 121 70
Measure Type: Number
Unit of Measure: Percent
0 0 0
74.Secondary Outcome
Title Change From Baseline in Viral Load at Each Visit, as Measured by RT-qPCR in Nasopharyngeal Swabs - (Phase 3 Cohort 1 - 1.2g vs. Placebo)
Hide Description Phase 3 Cohort 1
Time Frame Baseline up to Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Arm/Group Title Phase 3 Cohort 1 Placebo Phase 3 Cohort 1 (1.2g IV)
Hide Arm/Group Description:
Modified Full Analysis Set (mFAS) of Next Phase 3 Cohort 1 Participants
Phase 3 Cohort 1 Pediatric Participants Modified Full Analysis Set (mFAS)
Overall Number of Participants Analyzed 748 736
Mean (Standard Deviation)
Unit of Measure: log10 copies/mL
Day 7 Number Analyzed 695 participants 689 participants
-3.14  (1.964) -3.90  (2.027)
Day 15 Number Analyzed 672 participants 686 participants
-5.01  (2.068) -5.37  (2.098)
Day 29 Number Analyzed 676 participants 674 participants
-6.06  (1.976) -6.32  (2.107)
75.Secondary Outcome
Title Change From Baseline in Viral Load at Each Visit, as Measured by RT-qPCR in Nasopharyngeal Swabs - (Phase 3 Cohort 1 - 2.4g vs. Placebo)
Hide Description Phase 3 Cohort 1
Time Frame Baseline up to Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Arm/Group Title Phase 3 Cohort 1 Placebo Phase 3 Cohort 1 (2.4g IV)
Hide Arm/Group Description:
Modified Full Analysis Set (mFAS) of Next Phase 3 Cohort 1 Participants
Phase 3 Cohort 1 Pediatric Participants Modified Full Analysis Set (mFAS)
Overall Number of Participants Analyzed 1341 1355
Mean (Standard Deviation)
Unit of Measure: log10 copies/mL
Day 7 Number Analyzed 1227 participants 1277 participants
-3.01  (1.951) -3.89  (1.940)
Day 15 Number Analyzed 1196 participants 1259 participants
-5.02  (2.034) -5.44  (2.104)
Day 29 Number Analyzed 1207 participants 1256 participants
-6.08  (1.943) -6.19  (1.968)
76.Secondary Outcome
Title Change From Baseline in Viral Load at Each Visit, as Measured by RT-qPCR in Nasopharyngeal Swabs - (Phase 3 Cohort 2)
Hide Description Phase 3 Cohort 2
Time Frame Baseline up to Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Participants <18 years old who, at baseline, were not pregnant, had symptomatic COVID-19, and had at least 1 risk factor for developing severe disease
Arm/Group Title Phase 3 Cohort 2 Placebo Phase 3 Cohort 2 (1.2g IV) Phase 3 Cohort 2 (2.4g IV)
Hide Arm/Group Description:
Modified Full Analysis Set (mFAS) of Next Phase 3 Cohort 2 Participants
Phase 3 Cohort 2 (1.2g IV) Pediatric Participants Modified Full Analysis Set (mFAS)
Modified Full Analysis Set (mFAS) of Phase 3 Cohort (2.4g IV) Participants
Overall Number of Participants Analyzed 1 121 70
Mean (Standard Deviation)
Unit of Measure: log10 copies/mL
Day 7 Number Analyzed 1 participants 115 participants 59 participants
-1.95 [1]   (NA) -4.47  (2.522) -5.23  (1.985)
Day 15 Number Analyzed 1 participants 115 participants 58 participants
-4.50 [1]   (NA) -6.10  (2.058) -6.83  (1.940)
Day 29 Number Analyzed 1 participants 111 participants 57 participants
-4.50 [1]   (NA) -6.50  (1.930) -7.06  (1.724)
[1]
Inadequate number of events to calculate standard deviation
77.Secondary Outcome
Title Time-weighted Average Change From Baseline in Viral Load (log10 Copies/mL), as Measured by Quantitative Reverse Transcription Quantitative Polymerase Chain Reaction (RT-qPCR) in Nasopharyngeal (NP) Swab Samples (Ph3 Cohort 1)
Hide Description Phase 3 (Cohort 1)
Time Frame Baseline to Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Arm/Group Title Phase 3 Cohort 1 Placebo Phase 3 Cohort 1 2.4g IV Phase 3 Cohort 1 8.0g IV
Hide Arm/Group Description:
(Placebo) Participants who were ≥18 and not pregnant at time of randomization
(2.4g IV) Participants who were ≥18 and not pregnant at time of randomization
(8.0g IV) Participants who were ≥18 and not pregnant at time of randomization
Overall Number of Participants Analyzed 571 603 608
Mean (Standard Deviation)
Unit of Measure: log10 copies/mL
-1.46  (1.220) -2.02  (1.021) -2.05  (1.079)
78.Secondary Outcome
Title Time-weighted Average Change From Baseline in Viral Load (log10 Copies/mL), as Measured by Quantitative Reverse Transcription Quantitative Polymerase Chain Reaction (RT-qPCR) in Nasopharyngeal (NP) Swab Samples (Ph3 Cohort 2)
Hide Description Phase 3 (Cohort 2)
Time Frame Baseline to Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
Participants <18 years old who, at baseline, were not pregnant, had symptomatic COVID-19, and had at least 1 risk factor for developing severe disease
Arm/Group Title Phase 3 Cohort 2 Placebo Phase 3 Cohort 2 (1.2g IV) Phase 3 Cohort 2 (2.4g IV)
Hide Arm/Group Description:
(Placebo) Participants who were less than 18 and not pregnant at time of randomization
(1.2g IV) Participants who were less than 18 and not pregnant at time of randomization
(2.4g IV) Participants who were less than 18 and not pregnant at time of randomization
Overall Number of Participants Analyzed 1 117 62
Mean (Standard Deviation)
Unit of Measure: log10 copies/mL
-0.97 [1]   (NA) -2.49  (1.413) -2.94  (1.435)
[1]
Unable to calculate SD due to number of participants analyzed
79.Secondary Outcome
Title Proportion of Participants With Viral Loads Below the Lower Limit of Detection at Each Visit - (Phase 2 Only)
Hide Description Next Phase 2 Symptomatic
Time Frame Day 0, Day 5, Day 7, Day 15, Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Participants analyzed are part of modified Full Analysis Set (mFAS) and have documented status at baseline. Next Phase 2 participants included the next 524 participants randomized to Phase 2 subsequent to the first 275 symptomatic participants randomized in Phase 1 / 2
Arm/Group Title Next Phase 2 (Placebo) Next Phase 2 (2.4g IV) Next Phase 2 (8.0g IV)
Hide Arm/Group Description:
Next Phase 2 Placebo Participants
Next Phase 2 Participants 2.4g IV
Next Phase 2 Participants 8.0g IV
Overall Number of Participants Analyzed 150 142 145
Measure Type: Count of Participants
Unit of Measure: Participants
Day 0 (Baseline) Number Analyzed 150 participants 142 participants 145 participants
0
   0.0%
0
   0.0%
0
   0.0%
Day 5 Number Analyzed 140 participants 134 participants 136 participants
20
  14.3%
21
  15.7%
21
  15.4%
Day 7 Number Analyzed 139 participants 131 participants 132 participants
27
  19.4%
22
  16.8%
34
  25.8%
Day 15 Number Analyzed 100 participants 98 participants 95 participants
59
  59.0%
59
  60.2%
60
  63.2%
Day 29 Number Analyzed 53 participants 49 participants 55 participants
43
  81.1%
42
  85.7%
48
  87.3%
80.Secondary Outcome
Title Proportion of Participants With Viral Loads Below the Lower Limit of Quantitation at Each Visit - (Phase 2 Only)
Hide Description Next Phase 2 Symptomatic
Time Frame Day 0, Day 5, Day 7, Day 15, Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Participants analyzed are part of modified Full Analysis Set (mFAS) and have documented status at baseline. Next Phase 2 participants included the next 524 participants randomized to Phase 2 subsequent to the first 275 symptomatic participants randomized in Phase 1 / 2
Arm/Group Title Next Phase 2 (Placebo) Next Phase 2 (2.4g IV) Next Phase 2 (8.0g IV)
Hide Arm/Group Description:
Next Phase 2 Placebo Participants
Next Phase 2 Participants 2.4g IV
Next Phase 2 Participants 8.0g IV
Overall Number of Participants Analyzed 150 142 145
Measure Type: Count of Participants
Unit of Measure: Participants
Day 0 (Baseline) Number Analyzed 150 participants 142 participants 145 participants
6
   4.0%
5
   3.5%
6
   4.1%
Day 5 Number Analyzed 140 participants 134 participants 136 participants
25
  17.9%
26
  19.4%
28
  20.6%
Day 7 Number Analyzed 139 participants 131 participants 132 participants
38
  27.3%
38
  29.0%
47
  35.6%
Day 15 Number Analyzed 100 participants 98 participants 95 participants
68
  68.0%
72
  73.5%
74
  77.9%
Day 29 Number Analyzed 53 participants 49 participants 55 participants
50
  94.3%
46
  93.9%
51
  92.7%
81.Secondary Outcome
Title Number of Days of Hospitalization Due to COVID-19 (Ph3 Cohort 1) Placebo vs. 1.2g IV
Hide Description Phase 3 (Cohort 1)
Time Frame Through Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Arm/Group Title Phase 3 Cohort 1 (Placebo) Phase 3 Cohort 1 1.2g IV
Hide Arm/Group Description:
Modified Full Analysis Set (mFAS) of Next Phase 3 Cohort 1 Participants
Modified Full Analysis Set (mFAS) of Next Phase 3 Cohort 1 Participants 1.2g IV
Overall Number of Participants Analyzed 62 736
Mean (Standard Deviation)
Unit of Measure: Days
10.0  (7.16) 7.0  (8.04)
82.Secondary Outcome
Title Number of Days of Hospitalization Due to COVID-19 (Ph3 Cohort 1) Placebo vs. 2.4g IV
Hide Description Phase 3 (Cohort 1)
Time Frame Through Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Arm/Group Title Phase 3 Cohort 1 (Placebo) Phase 3 Cohort 1 Pediatric (2.4g IV)
Hide Arm/Group Description:
Phase 3 Cohort 1 (Placebo)
Phase 3 Cohort 1 Pediatric (2.4g IV)
Overall Number of Participants Analyzed 24 736
Mean (Standard Deviation)
Unit of Measure: Days
8.4  (6.74) 7.0  (8.04)
83.Secondary Outcome
Title Number of Days of Hospitalization Due to COVID-19 (Ph3 Cohort 2)
Hide Description Phase 3 (Cohort 2)
Time Frame Through Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Participants <18 years old who, at baseline, were not pregnant, had symptomatic COVID-19, and had at least 1 risk factor for developing severe disease. No participants were hospitalized, therefore no hospitalizations days took place.
Arm/Group Title Phase 3 Cohort 2 Pediatric (Placebo) Phase 3 Cohort 2 Pediatric (1.2g IV) Phase 3 Cohort 2 Pediatric (2.4g IV)
Hide Arm/Group Description:
Phase 3 Cohort 2 Pediatric (Placebo) modified Full Analysis Set (mFAS)
Phase 3 Cohort 2 Pediatric (1.2g IV) modified Full Analysis Set (mFAS)
Phase 3 Cohort 2 Pediatric (2.4g IV) modified Full Analysis Set (mFAS)
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
84.Secondary Outcome
Title Number of Days of Hospitalization Due to COVID-19 (Phase 2 Asymptomatic)
Hide Description Phase 2 Only
Time Frame Up to Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Phase 2 asymptomatic cohort. No participants were hospitalized, therefore no hospitalizations days took place.
Arm/Group Title Placebo Phase 2 Asymptomatic: 2.4 IV Phase 2 Asymptomatic: 8.0 IV
Hide Arm/Group Description:
Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
85.Secondary Outcome
Title Proportion of Participants Admitted to an Intensive Care Unit (ICU) Due to COVID-19 - (Ph 3 Cohort 1) Placebo vs. 1.2g IV
Hide Description Phase 3 (Cohort 1)
Time Frame Through Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Arm/Group Title Phase 3 Cohort 1 (Placebo) Phase 3 Cohort 1 (1.2g IV)
Hide Arm/Group Description:
Symptomatic Participants with COVID-19
Phase 3 Cohort 1 (1.2g IV)
Overall Number of Participants Analyzed 748 736
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Proportion of Participants
0.9
(0.4 to 1.9)
0.4
(0.1 to 1.2)
86.Secondary Outcome
Title Percentage of Participants Admitted to an Intensive Care Unit (ICU) Due to COVID-19 - (Ph 3 Cohort 1) Placebo vs. 2.4g IV
Hide Description Phase 3 (Cohort 1)
Time Frame Through Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Arm/Group Title Phase 3 Cohort 1 (Placebo) Phase 3 Cohort 1 (2.4g IV)
Hide Arm/Group Description:
Phase 3 Cohort 1 (Placebo)
Phase 3 Cohort 1 (2.4g IV)
Overall Number of Participants Analyzed 1341 1355
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
1.3
(0.8 to 2.1)
0.4
(0.2 to 1.0)
87.Secondary Outcome
Title Proportion of Participants Admitted to an Intensive Care Unit (ICU) Due to COVID-19 - (Ph 3 Cohort 2)
Hide Description Phase 3 (Cohort 2)
Time Frame Through Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Participants <18 years old who, at baseline, were not pregnant, had symptomatic COVID-19, and had at least 1 risk factor for developing severe disease
Arm/Group Title Phase 3 Cohort 2 Pediatric (Placebo) Phase 3 Cohort 2 Pediatric (1.2g IV) Phase 3 Cohort 2 Pediatric (2.4g IV)
Hide Arm/Group Description:
Phase 3 Cohort 2 Pediatric (Placebo) modified Full Analysis Set (mFAS)
Phase 3 Cohort 2 Pediatric (1.2g IV) modified Full Analysis Set (mFAS)
Phase 3 Cohort 2 Pediatric (2.4g IV) modified Full Analysis Set (mFAS)
Overall Number of Participants Analyzed 1 121 70
Measure Type: Number
Unit of Measure: Participants
0 0 0
88.Secondary Outcome
Title Proportion of Participants Admitted to an Intensive Care Unit (ICU) Due to COVID-19 - (Next Phase 2) #87
Hide Description Next Phase 2
Time Frame Through Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Participants analyzed are part of modified Full Analysis Set (mFAS) and have documented status at baseline. Next Phase 2 participants included the next 524 participants randomized to Phase 2 subsequent to the first 275 symptomatic participants randomized in Phase 1 / 2
Arm/Group Title Next Phase 2 (Placebo) Next Phase 2 (2.4g IV) Next Phase 2 (8.0g IV)
Hide Arm/Group Description:
Next Phase 2 Placebo Participants
Next Phase 2 Participants 2.4g IV
Next Phase 2 Participants 8.0g IV
Overall Number of Participants Analyzed 150 142 145
Measure Type: Number
Unit of Measure: Participants
0 0 0
89.Secondary Outcome
Title Total Number of COVID-19-related Medically-attended Visits (Phase 3 Cohort 1) Placebo vs. 1.2g
Hide Description Phase 3 Cohort 1
Time Frame Through Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Arm/Group Title Placebo Phase 3 Cohort 1 1.2g IV
Hide Arm/Group Description:
Placebo mFAS (modified Full Analysis Set)
Phase 3 Cohort 1 1.2 g IV mFAS (modified Full Analysis Set)
Overall Number of Participants Analyzed 51 20
Mean (Standard Deviation)
Unit of Measure: Number of Visits
1.1  (0.27) 1.2  (0.52)
90.Secondary Outcome
Title Total Number of COVID-19-related Medically-attended Visits (Phase 3 Cohort 1) Placebo vs. 2.4g
Hide Description Phase 3 Cohort 1
Time Frame Through Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Arm/Group Title Placebo Phase 3 Cohort 1 2.4g IV
Hide Arm/Group Description:
Placebo mFAS (modified Full Analysis Set)
Phase 3 Cohort 1 2.4g IV mFAS (modified Full Analysis Set)
Overall Number of Participants Analyzed 109 43
Mean (Standard Deviation)
Unit of Measure: Number of Visits
1.2  (0.41) 1.0  (0.15)
91.Secondary Outcome
Title Total Number of COVID-19-related Medically-attended Visits (Phase 3 Cohort 2)
Hide Description Phase 3 Cohort 2
Time Frame Through Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Participants <18 years old who, at baseline, were not pregnant, had symptomatic COVID-19, and had at least 1 risk factor for developing severe disease
Arm/Group Title Placebo Phase 3 Cohort 2 1.2g IV Phase 3 Cohort 2 2.4g IV
Hide Arm/Group Description:
Placebo mFAS (modified Full Analysis Set)
Phase 3 Cohort 2 1.2g IV mFAS (modified Full Analysis Set)
Phase 3 Cohort 2 2.4g IV mFAS (modified Full Analysis Set)
Overall Number of Participants Analyzed 1 121 70
Mean (Standard Deviation)
Unit of Measure: Number of Visits
1.0  (0.0) 1.0 [1]   (NA) 1.0  (0.0)
[1]
too small a number of data points to calculate
Time Frame From first dose to end of study (approx. 8 months)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Phase 1 Symptomatic Placebo Phase 1 Symptomatic R10933+R10987 2.4g IV Phase 1 Symptomatic R10933+R10987 8.0g IV Phase 2 Symptomatic Placebo Phase 2 Symptomatic R10933+R10987 2.4g IV Phase 2 Symptomatic R10933+R10987 8.0g IV Phase 2 Asymptomatic Placebo Phase 2 Asymptomatic R10933+R10987 2.4g IV Phase 2 Asymptomatic R10933+R10987 8.0g IV Phase 3 Age>=18 Placebo Phase 3 Age>=18 R10933+R10987 1.2g IV Phase 3 Age>=18 R10933+R10987 2.4g IV Phase 3 Age>=18 R10933+R10987 8.0g IV Phase 3 Age<18 Placebo Phase 3 Age<18 R10933+R10987 1.2g IV Phase 3 Age<18 R10933+R10987 2.4g IV Phase 3 Pregnant Placebo Phase 3 Pregnant R10933+R10987 1.2g IV Phase 3 Pregnant R10933+R10987 2.4g IV
Hide Arm/Group Description Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19 2.4g of R10933 + R10987 Adult Symptomatic Participants with COVID-19 8.0g of R10933 + R10987 Adult Symptomatic Participants with COVID-19 Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19 2.4g of R10933 + R10987 Adult Symptomatic Participants with COVID-19 8.0g of R10933 + R10987 Adult Symptomatic Participants with COVID-19 Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection 2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection 8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection Placebo of R10933 + R10987 Participants >=18 with COVID-19, not pregnant at randomization 1.2g of R10933 + R10987 Participants >=18 with COVID-19, not pregnant at randomization 2.4g of R10933 + R10987 Participants >=18 with COVID-19, not pregnant at randomization 8.0g of R10933 + R10987 Participants >=18 with COVID-19, not pregnant at randomization Placebo of R10933 + R10987 Participants <18 with COVID-19, not pregnant at randomization 1.2g of R10933 + R10987 Participants <18 with COVID-19 2.4g of R10933 + R10987 Participants <18 with COVID-19 Placebo of R10933 + R10987 Participants who are pregnant with COVID-19 1.2g of R10933 + R10987 Participants who are pregnant with COVID-19 2.4g of R10933 + R10987 Participants who are pregnant with COVID-19
All-Cause Mortality
Phase 1 Symptomatic Placebo Phase 1 Symptomatic R10933+R10987 2.4g IV Phase 1 Symptomatic R10933+R10987 8.0g IV Phase 2 Symptomatic Placebo Phase 2 Symptomatic R10933+R10987 2.4g IV Phase 2 Symptomatic R10933+R10987 8.0g IV Phase 2 Asymptomatic Placebo Phase 2 Asymptomatic R10933+R10987 2.4g IV Phase 2 Asymptomatic R10933+R10987 8.0g IV Phase 3 Age>=18 Placebo Phase 3 Age>=18 R10933+R10987 1.2g IV Phase 3 Age>=18 R10933+R10987 2.4g IV Phase 3 Age>=18 R10933+R10987 8.0g IV Phase 3 Age<18 Placebo Phase 3 Age<18 R10933+R10987 1.2g IV Phase 3 Age<18 R10933+R10987 2.4g IV Phase 3 Pregnant Placebo Phase 3 Pregnant R10933+R10987 1.2g IV Phase 3 Pregnant R10933+R10987 2.4g IV
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)      0/22 (0.00%)      0/23 (0.00%)      0/238 (0.00%)      0/236 (0.00%)      0/237 (0.00%)      0/73 (0.00%)      0/74 (0.00%)      0/75 (0.00%)      11/2347 (0.47%)      2/2130 (0.09%)      4/3157 (0.13%)      0/1012 (0.00%)      0/2 (0.00%)      0/129 (0.00%)      0/71 (0.00%)      0/2 (0.00%)      0/43 (0.00%)      0/35 (0.00%)    
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Phase 1 Symptomatic Placebo Phase 1 Symptomatic R10933+R10987 2.4g IV Phase 1 Symptomatic R10933+R10987 8.0g IV Phase 2 Symptomatic Placebo Phase 2 Symptomatic R10933+R10987 2.4g IV Phase 2 Symptomatic R10933+R10987 8.0g IV Phase 2 Asymptomatic Placebo Phase 2 Asymptomatic R10933+R10987 2.4g IV Phase 2 Asymptomatic R10933+R10987 8.0g IV Phase 3 Age>=18 Placebo Phase 3 Age>=18 R10933+R10987 1.2g IV Phase 3 Age>=18 R10933+R10987 2.4g IV Phase 3 Age>=18 R10933+R10987 8.0g IV Phase 3 Age<18 Placebo Phase 3 Age<18 R10933+R10987 1.2g IV Phase 3 Age<18 R10933+R10987 2.4g IV Phase 3 Pregnant Placebo Phase 3 Pregnant R10933+R10987 1.2g IV Phase 3 Pregnant R10933+R10987 2.4g IV
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/24 (0.00%)      1/22 (4.55%)      0/23 (0.00%)      6/238 (2.52%)      3/236 (1.27%)      2/237 (0.84%)      0/73 (0.00%)      0/74 (0.00%)      0/75 (0.00%)      103/2347 (4.39%)      39/2130 (1.83%)      52/3157 (1.65%)      19/1012 (1.88%)      0/2 (0.00%)      3/129 (2.33%)      0/71 (0.00%)      0/2 (0.00%)      11/43 (25.58%)      7/35 (20.00%)    
Blood and lymphatic system disorders                                       
Anaemia † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 1/2347 (0.04%)  1 0/2130 (0.00%)  0 0/3157 (0.00%)  0 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Immune thrombocytopenia † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 0/2347 (0.00%)  0 0/2130 (0.00%)  0 1/3157 (0.03%)  1 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Cardiac disorders                                       
Acute myocardial infarction † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 0/2347 (0.00%)  0 1/2130 (0.05%)  1 1/3157 (0.03%)  1 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Angina pectoris † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 1/236 (0.42%)  1 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 1/2347 (0.04%)  1 1/2130 (0.05%)  1 1/3157 (0.03%)  1 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Arrhythmia neonatal † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 1/2347 (0.04%)  1 0/2130 (0.00%)  0 0/3157 (0.00%)  0 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Atrial fibrillation † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 1/2347 (0.04%)  1 1/2130 (0.05%)  1 0/3157 (0.00%)  0 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Cardiac failure acute † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 0/2347 (0.00%)  0 0/2130 (0.00%)  0 1/3157 (0.03%)  1 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Cardiac failure congestive † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 0/2347 (0.00%)  0 1/2130 (0.05%)  2 0/3157 (0.00%)  0 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Cardio-respiratory arrest † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 0/2347 (0.00%)  0 0/2130 (0.00%)  0 1/3157 (0.03%)  1 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Coronary artery disease † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 1/2347 (0.04%)  1 0/2130 (0.00%)  0 0/3157 (0.00%)  0 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Mitral valve calcification † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 0/2347 (0.00%)  0 0/2130 (0.00%)  0 1/3157 (0.03%)  1 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Tachycardia † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 1/2347 (0.04%)  1 0/2130 (0.00%)  0 0/3157 (0.00%)  0 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Congenital, familial and genetic disorders                                       
Anal atresia † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 0/2347 (0.00%)  0 0/2130 (0.00%)  0 0/3157 (0.00%)  0 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 1/43 (2.33%)  1 0/35 (0.00%)  0
Craniosynostosis † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 0/2347 (0.00%)  0 0/2130 (0.00%)  0 0/3157 (0.00%)  0 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 1/35 (2.86%)  1
Foetal malformation † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 0/2347 (0.00%)  0 0/2130 (0.00%)  0 0/3157 (0.00%)  0 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 1/35 (2.86%)  1
Macrocephaly † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 0/2347 (0.00%)  0 0/2130 (0.00%)  0 0/3157 (0.00%)  0 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 1/43 (2.33%)  1 0/35 (0.00%)  0
Tracheo-oesophageal fistula † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 0/2347 (0.00%)  0 0/2130 (0.00%)  0 0/3157 (0.00%)  0 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 1/43 (2.33%)  1 0/35 (0.00%)  0
Ear and labyrinth disorders                                       
Vertigo † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 0/2347 (0.00%)  0 0/2130 (0.00%)  0 1/3157 (0.03%)  1 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Gastrointestinal disorders                                       
Abdominal pain † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 0/2347 (0.00%)  0 0/2130 (0.00%)  0 1/3157 (0.03%)  1 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Abdominal wall haematoma † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 0/2347 (0.00%)  0 0/2130 (0.00%)  0 1/3157 (0.03%)  1 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Colitis ischaemic † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 0/2347 (0.00%)  0 0/2130 (0.00%)  0 1/3157 (0.03%)  1 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Diverticulum † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 0/2347 (0.00%)  0 0/2130 (0.00%)  0 1/3157 (0.03%)  1 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Nausea † 1  0/24 (0.00%)  0 1/22 (4.55%)  1 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 1/2347 (0.04%)  1 0/2130 (0.00%)  0 0/3157 (0.00%)  0 1/1012 (0.10%)  1 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Pancreatitis † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 0/2347 (0.00%)  0 1/2130 (0.05%)  1 1/3157 (0.03%)  1 1/1012 (0.10%)  1 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Peptic ulcer perforation † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 1/2347 (0.04%)  1 0/2130 (0.00%)  0 0/3157 (0.00%)  0 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Umbilical hernia † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 0/2347 (0.00%)  0 0/2130 (0.00%)  0 1/3157 (0.03%)  1 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Vomiting † 1  0/24 (0.00%)  0 1/22 (4.55%)  1 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 1/2347 (0.04%)  1 0/2130 (0.00%)  0 0/3157 (0.00%)  0 1/1012 (0.10%)  1 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
General disorders                                       
Death † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 1/2347 (0.04%)  1 0/2130 (0.00%)  0 0/3157 (0.00%)  0 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Fever neonatal † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 1/2347 (0.04%)  1 0/2130 (0.00%)  0 0/3157 (0.00%)  0 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Impaired healing † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 0/2347 (0.00%)  0 0/2130 (0.00%)  0 1/3157 (0.03%)  1 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Multiple organ dysfunction syndrome † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 2/2347 (0.09%)  2 0/2130 (0.00%)  0 0/3157 (0.00%)  0 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Non-cardiac chest pain † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 1/2347 (0.04%)  1 1/2130 (0.05%)  3 2/3157 (0.06%)  2 1/1012 (0.10%)  1 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Pyrexia † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 1/2347 (0.04%)  1 0/2130 (0.00%)  0 1/3157 (0.03%)  1 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Hepatobiliary disorders                                       
Cholecystitis † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 0/2347 (0.00%)  0 1/2130 (0.05%)  1 1/3157 (0.03%)  1 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Cholecystitis acute † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 1/2347 (0.04%)  1 0/2130 (0.00%)  0 0/3157 (0.00%)  0 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Hyperbilirubinaemia neonatal † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 0/2347 (0.00%)  0 0/2130 (0.00%)  0 0/3157 (0.00%)  0 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 1/35 (2.86%)  1
Immune system disorders                                       
Anaphylactic reaction † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 0/2347 (0.00%)  0 1/2130 (0.05%)  1 0/3157 (0.00%)  0 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Infections and infestations                                       
Abdominal abscess † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 1/237 (0.42%)  1 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 0/2347 (0.00%)  0 0/2130 (0.00%)  0 0/3157 (0.00%)  0 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Abscess † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 1/2347 (0.04%)  1 0/2130 (0.00%)  0 0/3157 (0.00%)  0 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Abscess neck † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 1/2347 (0.04%)  1 0/2130 (0.00%)  0 0/3157 (0.00%)  0 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Appendicitis † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 0/2347 (0.00%)  0 0/2130 (0.00%)  0 1/3157 (0.03%)  1 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Bacteraemia † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 0/2347 (0.00%)  0 1/2130 (0.05%)  1 0/3157 (0.00%)  0 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Breast abscess † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 0/2347 (0.00%)  0 1/2130 (0.05%)  1 0/3157 (0.00%)  0 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
COVID-19 † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 1/238 (0.42%)  1 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 20/2347 (0.85%)  21 3/2130 (0.14%)  3 9/3157 (0.29%)  9 5/1012 (0.49%)  5 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
COVID-19 pneumonia † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 2/236 (0.85%)  2 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 19/2347 (0.81%)  21 5/2130 (0.23%)  5 6/3157 (0.19%)  6 5/1012 (0.49%)  5 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 1/35 (2.86%)  1
Clostridium difficile colitis † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 1/2347 (0.04%)  1 0/2130 (0.00%)  0 0/3157 (0.00%)  0 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Gastroenteritis † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 2/2347 (0.09%)  2 0/2130 (0.00%)  0 0/3157 (0.00%)  0 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Kidney infection † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 1/2347 (0.04%)  1 0/2130 (0.00%)  0 0/3157 (0.00%)  0 1/1012 (0.10%)  1 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Lung abscess † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 1/2347 (0.04%)  1 0/2130 (0.00%)  0 0/3157 (0.00%)  0 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Metapneumovirus pneumonia † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 0/2347 (0.00%)  0 0/2130 (0.00%)  0 0/3157 (0.00%)  0 0/1012 (0.00%)  0 0/2 (0.00%)  0 1/129 (0.78%)  1 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Pneumonia † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 2/238 (0.84%)  2 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 19/2347 (0.81%)  20 5/2130 (0.23%)  5 6/3157 (0.19%)  6 1/1012 (0.10%)  1 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Pneumonia viral † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 1/2347 (0.04%)  1 0/2130 (0.00%)  0 2/3157 (0.06%)  2 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Pyelonephritis † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 0/2347 (0.00%)  0 0/2130 (0.00%)  0 0/3157 (0.00%)  0 1/1012 (0.10%)  1 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Sepsis † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 2/2347 (0.09%)  2 0/2130 (0.00%)  0 2/3157 (0.06%)  2 1/1012 (0.10%)  1 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Staphylococcal bacteraemia † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 1/2347 (0.04%)  1 0/2130 (0.00%)  0 0/3157 (0.00%)  0 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Urinary tract infection † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 0/2347 (0.00%)  0 0/2130 (0.00%)  0 1/3157 (0.03%)  1 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Injury, poisoning and procedural complications                                       
Acetabulum fracture † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 1/2347 (0.04%)  1 0/2130 (0.00%)  0 0/3157 (0.00%)  0 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Ankle fracture † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 0/2347 (0.00%)  0 1/2130 (0.05%)  1 0/3157 (0.00%)  0 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Cervical vertebral fracture † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 0/2347 (0.00%)  0 1/2130 (0.05%)  1 0/3157 (0.00%)  0 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Facial bones fracture † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 0/2347 (0.00%)  0 0/2130 (0.00%)  0 1/3157 (0.03%)  1 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Fall † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 0/2347 (0.00%)  0 1/2130 (0.05%)  1 0/3157 (0.00%)  0 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Fractured sacrum † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 1/2347 (0.04%)  1 0/2130 (0.00%)  0 0/3157 (0.00%)  0 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Gastrointestinal anastomotic stenosis † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 1/2347 (0.04%)  1 0/2130 (0.00%)  0 0/3157 (0.00%)  0 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Pelvic fracture † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 1/2347 (0.04%)  1 0/2130 (0.00%)  0 0/3157 (0.00%)  0 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Spinal compression fracture † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 0/2347 (0.00%)  0 1/2130 (0.05%)  1 0/3157 (0.00%)  0 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Tibia fracture † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 0/2347 (0.00%)  0 1/2130 (0.05%)  1 0/3157 (0.00%)  0 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Upper limb fracture † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 0/2347 (0.00%)  0 1/2130 (0.05%)  1 0/3157 (0.00%)  0 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Investigations                                       
Blood creatine phosphokinase increased † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 1/2347 (0.04%)  1 0/2130 (0.00%)  0 0/3157 (0.00%)  0 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Continuous glucose monitoring † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 0/2347 (0.00%)  0 0/2130 (0.00%)  0 0/3157 (0.00%)  0 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 1/43 (2.33%)  1 0/35 (0.00%)  0
Metabolism and nutrition disorders                                       
Dehydration † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 2/2347 (0.09%)  2 1/2130 (0.05%)  1 0/3157 (0.00%)  0 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Diabetes mellitus † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 0/2347 (0.00%)  0 0/2130 (0.00%)  0 0/3157 (0.00%)  0 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 1/43 (2.33%)  1 0/35 (0.00%)  0
Diabetes mellitus inadequate control † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 0/2347 (0.00%)  0 1/2130 (0.05%)  1 0/3157 (0.00%)  0 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Gout † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 0/2347 (0.00%)  0 1/2130 (0.05%)  1 0/3157 (0.00%)  0 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Hyperglycaemia † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 1/236 (0.42%)  1 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 0/2347 (0.00%)  0 0/2130 (0.00%)  0 1/3157 (0.03%)  1 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Hypokalaemia † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 1/2347 (0.04%)  1 0/2130 (0.00%)  0 0/3157 (0.00%)  0 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Hyponatraemia † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 3/2347 (0.13%)  3 0/2130 (0.00%)  0 0/3157 (0.00%)  0 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Musculoskeletal and connective tissue disorders                                       
Muscular weakness † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 1/2347 (0.04%)  1 0/2130 (0.00%)  0 0/3157 (0.00%)  0 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Rhabdomyolysis † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 0/2347 (0.00%)  0 1/2130 (0.05%)  1 0/3157 (0.00%)  0 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                                       
Colon cancer † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 0/2347 (0.00%)  0 0/2130 (0.00%)  0 1/3157 (0.03%)  1 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Gastric cancer † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 1/2347 (0.04%)  1 0/2130 (0.00%)  0 0/3157 (0.00%)  0 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Rectal neoplasm † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 1/2347 (0.04%)  1 0/2130 (0.00%)  0 0/3157 (0.00%)  0 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Nervous system disorders                                       
Haemorrhagic stroke † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 0/2347 (0.00%)  0 1/2130 (0.05%)  1 1/3157 (0.03%)  1 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Hypoaesthesia † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 0/2347 (0.00%)  0 1/2130 (0.05%)  1 0/3157 (0.00%)  0 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Hyporesponsive to stimuli † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 0/2347 (0.00%)  0 0/2130 (0.00%)  0 0/3157 (0.00%)  0 1/1012 (0.10%)  1 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Migraine † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 0/2347 (0.00%)  0 1/2130 (0.05%)  1 0/3157 (0.00%)  0 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Transient ischaemic attack † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 0/2347 (0.00%)  0 0/2130 (0.00%)  0 1/3157 (0.03%)  1 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Pregnancy, puerperium and perinatal conditions                                       
Abnormal labour † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 0/2347 (0.00%)  0 0/2130 (0.00%)  0 0/3157 (0.00%)  0 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 1/35 (2.86%)  1
Abortion spontaneous † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 0/2347 (0.00%)  0 1/2130 (0.05%)  1 1/3157 (0.03%)  1 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 1/43 (2.33%)  1 0/35 (0.00%)  0
Ectopic pregnancy † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 0/2347 (0.00%)  0 1/2130 (0.05%)  1 1/3157 (0.03%)  1 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Foetal growth restriction † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 0/2347 (0.00%)  0 0/2130 (0.00%)  0 0/3157 (0.00%)  0 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 1/35 (2.86%)  1
Pre-eclampsia † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 0/2347 (0.00%)  0 0/2130 (0.00%)  0 0/3157 (0.00%)  0 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 3/43 (6.98%)  3 1/35 (2.86%)  1
Premature baby † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 0/2347 (0.00%)  0 0/2130 (0.00%)  0 0/3157 (0.00%)  0 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 1/43 (2.33%)  1 0/35 (0.00%)  0
Premature separation of placenta † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 0/2347 (0.00%)  0 0/2130 (0.00%)  0 0/3157 (0.00%)  0 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 1/43 (2.33%)  1 0/35 (0.00%)  0
Preterm premature rupture of membranes † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 0/2347 (0.00%)  0 0/2130 (0.00%)  0 0/3157 (0.00%)  0 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 1/35 (2.86%)  1
Ruptured ectopic pregnancy † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 0/2347 (0.00%)  0 0/2130 (0.00%)  0 1/3157 (0.03%)  1 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Psychiatric disorders                                       
Bipolar disorder † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 0/2347 (0.00%)  0 1/2130 (0.05%)  1 0/3157 (0.00%)  0 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Depression † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 1/2347 (0.04%)  1 0/2130 (0.00%)  0 0/3157 (0.00%)  0 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Mental status changes † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 0/2347 (0.00%)  0 1/2130 (0.05%)  1 0/3157 (0.00%)  0 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Perinatal depression † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 0/2347 (0.00%)  0 0/2130 (0.00%)  0 0/3157 (0.00%)  0 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 1/43 (2.33%)  1 0/35 (0.00%)  0
Suicidal ideation † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 0/2347 (0.00%)  0 0/2130 (0.00%)  0 0/3157 (0.00%)  0 0/1012 (0.00%)  0 0/2 (0.00%)  0 1/129 (0.78%)  1 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Renal and urinary disorders                                       
Acute kidney injury † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 1/2347 (0.04%)  1 0/2130 (0.00%)  0 1/3157 (0.03%)  1 1/1012 (0.10%)  1 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Nephrolithiasis † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 0/2347 (0.00%)  0 1/2130 (0.05%)  1 0/3157 (0.00%)  0 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 1/43 (2.33%)  1 1/35 (2.86%)  1
Renal failure † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 1/2347 (0.04%)  1 0/2130 (0.00%)  0 0/3157 (0.00%)  0 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Urinary retention † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 0/2347 (0.00%)  0 0/2130 (0.00%)  0 0/3157 (0.00%)  0 0/1012 (0.00%)  0 0/2 (0.00%)  0 1/129 (0.78%)  1 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Reproductive system and breast disorders                                       
Abnormal uterine bleeding † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 0/2347 (0.00%)  0 1/2130 (0.05%)  1 0/3157 (0.00%)  0 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Respiratory, thoracic and mediastinal disorders                                       
Acute respiratory distress syndrome † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 1/2347 (0.04%)  1 0/2130 (0.00%)  0 0/3157 (0.00%)  0 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Acute respiratory failure † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 5/2347 (0.21%)  5 0/2130 (0.00%)  0 2/3157 (0.06%)  2 1/1012 (0.10%)  1 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Atelectasis † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 0/2347 (0.00%)  0 0/2130 (0.00%)  0 0/3157 (0.00%)  0 1/1012 (0.10%)  1 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Chronic obstructive pulmonary disease † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 1/2347 (0.04%)  1 0/2130 (0.00%)  0 1/3157 (0.03%)  1 1/1012 (0.10%)  1 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Cough † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 1/2347 (0.04%)  1 0/2130 (0.00%)  0 0/3157 (0.00%)  0 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Dyspnoea † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 1/237 (0.42%)  1 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 10/2347 (0.43%)  10 1/2130 (0.05%)  1 1/3157 (0.03%)  1 1/1012 (0.10%)  1 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Haemothorax † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 0/2347 (0.00%)  0 0/2130 (0.00%)  0 1/3157 (0.03%)  1 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Hypoxia † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 2/238 (0.84%)  2 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 6/2347 (0.26%)  6 1/2130 (0.05%)  1 2/3157 (0.06%)  2 1/1012 (0.10%)  1 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Interstitial lung disease † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 1/2347 (0.04%)  1 0/2130 (0.00%)  0 1/3157 (0.03%)  1 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Pneumothorax spontaneous † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 1/2347 (0.04%)  1 0/2130 (0.00%)  0 0/3157 (0.00%)  0 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Pulmonary congestion † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 0/2347 (0.00%)  0 0/2130 (0.00%)  0 1/3157 (0.03%)  1 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Pulmonary embolism † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 1/2347 (0.04%)  1 2/2130 (0.09%)  2 1/3157 (0.03%)  1 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Pulmonary mass † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 1/2347 (0.04%)  1 0/2130 (0.00%)  0 0/3157 (0.00%)  0 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Respiratory distress † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 2/2347 (0.09%)  2 0/2130 (0.00%)  0 0/3157 (0.00%)  0 0/1012 (0.00%)  0 0/2 (0.00%)  0 1/129 (0.78%)  1 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Respiratory failure † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 1/2347 (0.04%)  2 0/2130 (0.00%)  0 1/3157 (0.03%)  1 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Skin and subcutaneous tissue disorders                                       
Hyperhidrosis † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 0/2347 (0.00%)  0 0/2130 (0.00%)  0 0/3157 (0.00%)  0 1/1012 (0.10%)  1 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Surgical and medical procedures                                       
Hospitalisation † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 1/2347 (0.04%)  1 0/2130 (0.00%)  0 0/3157 (0.00%)  0 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Vascular disorders                                       
Deep vein thrombosis † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 1/2347 (0.04%)  1 0/2130 (0.00%)  0 0/3157 (0.00%)  0 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
Hypertension † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 1/238 (0.42%)  1 1/236 (0.42%)  1 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 0/2347 (0.00%)  0 0/2130 (0.00%)  0 1/3157 (0.03%)  1 1/1012 (0.10%)  1 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
May-Thurner syndrome † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 1/2347 (0.04%)  1 0/2130 (0.00%)  0 0/3157 (0.00%)  0 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 0/43 (0.00%)  0 0/35 (0.00%)  0
1
Term from vocabulary, MedDRA 25.0
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Phase 1 Symptomatic Placebo Phase 1 Symptomatic R10933+R10987 2.4g IV Phase 1 Symptomatic R10933+R10987 8.0g IV Phase 2 Symptomatic Placebo Phase 2 Symptomatic R10933+R10987 2.4g IV Phase 2 Symptomatic R10933+R10987 8.0g IV Phase 2 Asymptomatic Placebo Phase 2 Asymptomatic R10933+R10987 2.4g IV Phase 2 Asymptomatic R10933+R10987 8.0g IV Phase 3 Age>=18 Placebo Phase 3 Age>=18 R10933+R10987 1.2g IV Phase 3 Age>=18 R10933+R10987 2.4g IV Phase 3 Age>=18 R10933+R10987 8.0g IV Phase 3 Age<18 Placebo Phase 3 Age<18 R10933+R10987 1.2g IV Phase 3 Age<18 R10933+R10987 2.4g IV Phase 3 Pregnant Placebo Phase 3 Pregnant R10933+R10987 1.2g IV Phase 3 Pregnant R10933+R10987 2.4g IV
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/24 (0.00%)      0/22 (0.00%)      0/23 (0.00%)      2/238 (0.84%)      1/236 (0.42%)      1/237 (0.42%)      0/73 (0.00%)      0/74 (0.00%)      0/75 (0.00%)      16/2347 (0.68%)      16/2130 (0.75%)      19/3157 (0.60%)      4/1012 (0.40%)      1/2 (50.00%)      0/129 (0.00%)      1/71 (1.41%)      0/2 (0.00%)      5/43 (11.63%)      3/35 (8.57%)    
Blood and lymphatic system disorders                                       
Anaemia † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 0/2347 (0.00%)  0 0/2130 (0.00%)  0 7/3157 (0.22%)  7 1/1012 (0.10%)  1 0/2 (0.00%)  0 0/129 (0.00%)  0 1/71 (1.41%)  1 0/2 (0.00%)  0 3/43 (6.98%)  3 0/35 (0.00%)  0
Pregnancy, puerperium and perinatal conditions                                       
Gestational diabetes † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 0/238 (0.00%)  0 0/236 (0.00%)  0 0/237 (0.00%)  0 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 0/2347 (0.00%)  0 0/2130 (0.00%)  0 0/3157 (0.00%)  0 0/1012 (0.00%)  0 0/2 (0.00%)  0 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 1/43 (2.33%)  1 2/35 (5.71%)  2
Respiratory, thoracic and mediastinal disorders                                       
Dyspnoea † 1  0/24 (0.00%)  0 0/22 (0.00%)  0 0/23 (0.00%)  0 2/238 (0.84%)  2 1/236 (0.42%)  1 1/237 (0.42%)  1 0/73 (0.00%)  0 0/74 (0.00%)  0 0/75 (0.00%)  0 16/2347 (0.68%)  16 16/2130 (0.75%)  17 12/3157 (0.38%)  12 3/1012 (0.30%)  3 1/2 (50.00%)  1 0/129 (0.00%)  0 0/71 (0.00%)  0 0/2 (0.00%)  0 1/43 (2.33%)  1 1/35 (2.86%)  1
1
Term from vocabulary, MedDRA 25.0
†
Indicates events were collected by systematic assessment
Nasal and saliva sample collection was discontinued early in the study because nasopharyngeal samples were determined to be more reliable for quantitative analysis, as such endpoints related to nasal or saliva samples were not analyzed. The Phase 1/2 SAP does not specify any analyses related to nasal and saliva samples collections
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The investigator has the right to independently publish study results from the investigator's site after a multi-center publication, or a defined period after the completion of the study by all sites. The investigator must provide the sponsor a copy of any such publication derived from the study for review and comment in advance of any submission, and delay publication, if requested, to allow the Sponsor to preserve its proprietary rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Trials Administrator
Organization: Regeneron Pharmaceuticals, Inc.
Phone: 8447346643
EMail: clinicaltrials@regeneron.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04425629    
Other Study ID Numbers: R10933-10987-COV-2067
2020-003690-21 ( EudraCT Number )
First Submitted: June 8, 2020
First Posted: June 11, 2020
Results First Submitted: January 20, 2023
Results First Posted: December 21, 2023
Last Update Posted: December 21, 2023