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Study to Evaluate the Efficacy and Safety of Remdesivir in Participants With Severely Reduced Kidney Function Who Are Hospitalized for Coronavirus Disease 2019 (COVID-19) (REDPINE)

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ClinicalTrials.gov Identifier: NCT04745351
Recruitment Status : Terminated (The study was terminated due to study enrollment feasibility. This decision is not based on efficacy or safety concerns.)
First Posted : February 9, 2021
Results First Posted : May 12, 2023
Last Update Posted : May 12, 2023
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition COVID-19
Interventions Drug: Remdesivir
Drug: RDV Placebo
Drug: Standard of Care
Enrollment 249
Recruitment Details Participants were enrolled at study sites in Brazil, Portugal, Spain, the United Kingdom, and the United States.
Pre-assignment Details 258 participants were screened.
Arm/Group Title Remdesivir (RDV) Placebo
Hide Arm/Group Description Participants received continued Standard of Care (SOC) therapy together with RDV 200 mg intravenous (IV) infusion on Day 1 followed by RDV 100 mg IV infusion from Day 2 up to Day 5. Participants received continued SOC therapy together with RDV matching placebo IV saline on Day 1 followed by RDV matching placebo IV saline from Day 2 up to Day 5.
Period Title: Overall Study
Started 166 83
Completed 95 50
Not Completed 71 33
Reason Not Completed
Death             51             25
Lost to Follow-up             9             3
Randomized but Never Treated             3             3
Adverse Event             4             0
Withdrew Consent             1             2
Investigator's Discretion             2             0
Protocol Violation             1             0
Arm/Group Title Remdesivir (RDV) Placebo Total
Hide Arm/Group Description Participants received continued SOC therapy together with RDV 200 mg IV infusion on Day 1 followed by RDV 100 mg IV infusion from Day 2 up to Day 5. Participants received continued SOC therapy together with RDV matching placebo IV saline on Day 1 followed by RDV matching placebo IV saline from Day 2 up to Day 5. Total of all reporting groups
Overall Number of Baseline Participants 163 80 243
Hide Baseline Analysis Population Description
Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 163 participants 80 participants 243 participants
68  (14.1) 71  (13.0) 69  (13.8)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Age Categorical Number Analyzed 163 participants 80 participants 243 participants
< 18 Years
0
   0.0%
0
   0.0%
0
   0.0%
>= 18 to < 65 Years
70
  42.9%
22
  27.5%
92
  37.9%
>= 65 Years
93
  57.1%
58
  72.5%
151
  62.1%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 163 participants 80 participants 243 participants
Female
71
  43.6%
33
  41.3%
104
  42.8%
Male
92
  56.4%
47
  58.8%
139
  57.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 163 participants 80 participants 243 participants
Hispanic or Latino
23
  14.1%
8
  10.0%
31
  12.8%
Not Hispanic or Latino
135
  82.8%
72
  90.0%
207
  85.2%
Unknown or Not Reported
5
   3.1%
0
   0.0%
5
   2.1%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 163 participants 80 participants 243 participants
American Indian or Alaska Native
1
   0.6%
0
   0.0%
1
   0.4%
Asian
4
   2.5%
2
   2.5%
6
   2.5%
Black
43
  26.4%
18
  22.5%
61
  25.1%
Native Hawaiian or Pacific Islander
1
   0.6%
0
   0.0%
1
   0.4%
White
104
  63.8%
55
  68.8%
159
  65.4%
Other
8
   4.9%
3
   3.8%
11
   4.5%
Unknown or Not Reported
2
   1.2%
2
   2.5%
4
   1.6%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 163 participants 80 participants 243 participants
United States
121
  74.2%
59
  73.8%
180
  74.1%
Spain
26
  16.0%
13
  16.3%
39
  16.0%
Portugal
13
   8.0%
6
   7.5%
19
   7.8%
United Kingdom
2
   1.2%
2
   2.5%
4
   1.6%
Brazil
1
   0.6%
0
   0.0%
1
   0.4%
Clinical Status (8-point Ordinal Scale)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 163 participants 80 participants 243 participants
Score: 1
0
   0.0%
0
   0.0%
0
   0.0%
Score: 2
0
   0.0%
0
   0.0%
0
   0.0%
Score: 3
0
   0.0%
0
   0.0%
0
   0.0%
Score: 4
36
  22.1%
18
  22.5%
54
  22.2%
Score: 5
97
  59.5%
47
  58.8%
144
  59.3%
Score: 6
30
  18.4%
15
  18.8%
45
  18.5%
Score: 7
0
   0.0%
0
   0.0%
0
   0.0%
Score: 8
0
   0.0%
0
   0.0%
0
   0.0%
[1]
Measure Description: The 8-point Ordinal scale assesses the clinical status of participants:1.Not hospitalized, no limitations on activities;2.Not hospitalized, limitation on activities/requiring home oxygen;3.Hospitalized,not requiring supplemental oxygen,no longer require ongoing medical care; 4.Hospitalized,not requiring supplemental oxygen-require ongoing medical care for COVID-19-specific medical care;5.Hospitalized,supplemental oxygen;6.Hospitalized,on noninvasive ventilation or highflow oxygen devices;7.Hospitalized,on invasive mechanical ventilation (IMV)/extracorporeal membrane oxygenation (ECMO);8.Death.
1.Primary Outcome
Title Percentage of Participants With All-cause Death or Invasive Mechanical Ventilation (IMV) Through Day 29
Hide Description This is the combined outcome measure reporting the percentage of participants with all-cause death or IMV through Day 29. The reported percentage was from the Kaplan-Meier estimate.
Time Frame First dose date up to Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
Arm/Group Title Remdesivir (RDV) Placebo
Hide Arm/Group Description:
Participants received continued SOC therapy together with RDV 200 mg IV infusion on Day 1 followed by RDV 100 mg IV infusion from Day 2 up to Day 5.
Participants received continued SOC therapy together with RDV matching placebo IV saline on Day 1 followed by RDV matching placebo IV saline from Day 2 up to Day 5.
Overall Number of Participants Analyzed 163 80
Measure Type: Number
Unit of Measure: percentage of participants
30.2 33.5
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Remdesivir (RDV), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6132
Comments P-value was calculated from stratified log-rank test, stratified by the baseline stratification factors.
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.816
Confidence Interval (2-Sided) 95%
0.504 to 1.321
Estimation Comments [Not Specified]
2.Secondary Outcome
Title All-cause Mortality Through Day 29
Hide Description The reported percentage was from the Kaplan-Meier estimate.
Time Frame First dose date up to Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set were analyzed.
Arm/Group Title Remdesivir (RDV) Placebo
Hide Arm/Group Description:
Participants received continued SOC therapy together with RDV 200 mg IV infusion on Day 1 followed by RDV 100 mg IV infusion from Day 2 up to Day 5.
Participants received continued SOC therapy together with RDV matching placebo IV saline on Day 1 followed by RDV matching placebo IV saline from Day 2 up to Day 5.
Overall Number of Participants Analyzed 163 80
Measure Type: Number
Unit of Measure: percentage of participants
25.9 29.7
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Remdesivir (RDV), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3881
Comments P-value was calculated from stratified log-rank test stratified by the baseline stratification factors.
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.830
Confidence Interval (2-Sided) 95%
0.497 to 1.388
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants With Initiation of IMV Through Day 29
Hide Description The reported percentage was the cumulative-incidence estimate.
Time Frame First dose date up to Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set were analyzed.
Arm/Group Title Remdesivir (RDV) Placebo
Hide Arm/Group Description:
Participants received continued SOC therapy together with RDV 200 mg IV infusion on Day 1 followed by RDV 100 mg IV infusion from Day 2 up to Day 5.
Participants received continued SOC therapy together with RDV matching placebo IV saline on Day 1 followed by RDV matching placebo IV saline from Day 2 up to Day 5.
Overall Number of Participants Analyzed 163 80
Measure Type: Number
Unit of Measure: percentage of participants
13.8 12.8
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Remdesivir (RDV), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9116
Comments The treatment effect p-value was calculated using Cox model with death as the competing risk and baseline stratification factors as covariates.
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.043
Confidence Interval (2-Sided) 95%
0.493 to 2.207
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Time to Recovery Without Subsequent Worsening (Defined as an Ordinal Scale Score of > 4) by Day 29
Hide Description Time to recovery is the time from first dose to recovery. Recovery is defined as the first day on which the participant with a baseline score ≥ 4, satisfies categories 1, 2, or 3 from the 8-point ordinal scale: 1) Non-hospitalized, no limitations on activities; 2) Non-hospitalized, limitations on activities/requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care for COVID-19; 5) Hospitalized, supplemental oxygen; 6) Hospitalized, on noninvasive ventilation; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 8) Death. Cumulative incidence was reported.
Time Frame First dose date up to Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set were analyzed.
Arm/Group Title Remdesivir (RDV) Placebo
Hide Arm/Group Description:
Participants received continued SOC therapy together with RDV 200 mg IV infusion on Day 1 followed by RDV 100 mg IV infusion from Day 2 up to Day 5.
Participants received continued SOC therapy together with RDV matching placebo IV saline on Day 1 followed by RDV matching placebo IV saline from Day 2 up to Day 5.
Overall Number of Participants Analyzed 163 80
Median (Inter-Quartile Range)
Unit of Measure: days
20 [1] 
(7 to NA)
19 [1] 
(7 to NA)
[1]
Upper bound of range (Q3) was not estimable due to less than 75% of participants with recovery.
5.Secondary Outcome
Title Time to Recovery Independent of Further Worsening by Day 29
Hide Description Time to recovery is the time from first dose to recovery. Recovery is defined as the first day on which the participant with a baseline score ≥ 4, satisfies categories 1, 2, or 3 from the 8-point ordinal scale: 1) Non-hospitalized, no limitations on activities; 2) Non-hospitalized, limitations on activities/requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care for COVID-19; 5) Hospitalized, supplemental oxygen; 6) Hospitalized, on noninvasive ventilation; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 8) Death. Cumulative incidence was reported.
Time Frame First dose date up to Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set were analyzed.
Arm/Group Title Remdesivir (RDV) Placebo
Hide Arm/Group Description:
Participants received continued SOC therapy together with RDV 200 mg IV infusion on Day 1 followed by RDV 100 mg IV infusion from Day 2 up to Day 5.
Participants received continued SOC therapy together with RDV matching placebo IV saline on Day 1 followed by RDV matching placebo IV saline from Day 2 up to Day 5.
Overall Number of Participants Analyzed 163 80
Median (Inter-Quartile Range)
Unit of Measure: days
10 [1] 
(6 to NA)
13 [1] 
(6 to NA)
[1]
Q3 was not estimable due to less than 75% of participants with recovery.
6.Secondary Outcome
Title Percentage of Participants Within Each Clinical Status Category as Assessed by an 8-Point Ordinal Scale on Day 15
Hide Description Clinical status is derived from death, hospital discharge, and the ordinal scale. Each day, the worst (highest) score from the previous day was recorded. The 8-point Ordinal scale is as follows: 1. Not hospitalized, no limitations on activities; 2. Not hospitalized, limitation on activities and/or requiring home oxygen; 3. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care (other than per-protocol RDV/saline as placebo administration); 4. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care for COVID-19-specific medical care (other than per-protocol RDV administration); 5. Hospitalized, supplemental oxygen; 6. Hospitalized, on noninvasive ventilation or high-flow oxygen devices; 7. Hospitalized, on IMV or ECMO; and 8. Death. Higher scores indicate worse clinical status.
Time Frame Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set were analyzed.
Arm/Group Title Remdesivir (RDV) Placebo
Hide Arm/Group Description:
Participants received continued SOC therapy together with RDV 200 mg IV infusion on Day 1 followed by RDV 100 mg IV infusion from Day 2 up to Day 5.
Participants received continued SOC therapy together with RDV matching placebo IV saline on Day 1 followed by RDV matching placebo IV saline from Day 2 up to Day 5.
Overall Number of Participants Analyzed 163 80
Measure Type: Number
Unit of Measure: percentage of participants
Score: 1 0 0
Score: 2 48.5 48.8
Score: 3 5.5 2.5
Score: 4 9.2 7.5
Score: 5 6.1 11.3
Score: 6 8.0 5.0
Score: 7 4.9 6.3
Score: 8 17.8 18.8
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Remdesivir (RDV), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8541
Comments P-value was analysed from proportional odds model including treatment as the independent variable.
Method Proportional odds model
Comments [Not Specified]
7.Secondary Outcome
Title Percentage of Participants Within Each Clinical Status Category as Assessed by an 8-Point Ordinal Scale on Day 29
Hide Description Clinical status is derived from death, hospital discharge, and the ordinal scale. Each day, the worst (highest) score from the previous day was recorded. The 8-point Ordinal scale is as follows: 1. Not hospitalized, no limitations on activities; 2. Not hospitalized, limitation on activities and/or requiring home oxygen; 3. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care (other than per-protocol RDV/saline as placebo administration); 4. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care for COVID-19-specific medical care (other than per-protocol RDV administration); 5. Hospitalized, supplemental oxygen; 6. Hospitalized, on noninvasive ventilation or high-flow oxygen devices; 7. Hospitalized, on IMV or ECMO; and 8. Death. Higher scores indicate worse clinical status.
Time Frame Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set were analyzed.
Arm/Group Title Remdesivir (RDV) Placebo
Hide Arm/Group Description:
Participants received continued SOC therapy together with RDV 200 mg IV infusion on Day 1 followed by RDV 100 mg IV infusion from Day 2 up to Day 5.
Participants received continued SOC therapy together with RDV matching placebo IV saline on Day 1 followed by RDV matching placebo IV saline from Day 2 up to Day 5.
Overall Number of Participants Analyzed 163 80
Measure Type: Number
Unit of Measure: percentage of participants
Score: 1 11.7 16.3
Score: 2 42.9 45.0
Score: 3 3.1 2.5
Score: 4 4.3 1.3
Score: 5 9.2 2.5
Score: 6 1.8 1.3
Score: 7 1.8 2.5
Score: 8 25.2 28.8
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Remdesivir (RDV), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4974
Comments P-value was analysed from proportional odds model including treatment as the independent variable.
Method Proportional odds model
Comments [Not Specified]
8.Secondary Outcome
Title Renal Replacement Therapy (RRT)-Free Days (Among Those Without End-Stage Kidney Disease [ESKD] at Baseline) Through Day 29
Hide Description The number of RRT free days were calculated as the number of full days from Day 1 to Day 29 on which the participant was alive and did not receive RRT.
Time Frame First dose date up to Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Participants without ESKD at baseline in the Full Analysis Set with available data were analyzed.
Arm/Group Title Remdesivir (RDV) Placebo
Hide Arm/Group Description:
Participants received continued SOC therapy together with RDV 200 mg IV infusion on Day 1 followed by RDV 100 mg IV infusion from Day 2 up to Day 5.
Participants received continued SOC therapy together with RDV matching placebo IV saline on Day 1 followed by RDV matching placebo IV saline from Day 2 up to Day 5.
Overall Number of Participants Analyzed 104 50
Median (Full Range)
Unit of Measure: days
29
(1 to 29)
29
(4 to 29)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Remdesivir (RDV), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4283
Comments P-value was calculated based on Wilcoxon rank sum test.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
9.Secondary Outcome
Title Percentage of Participants With Recovery Without Subsequent Worsening (Defined as an Ordinal Scale Score of > 4) Through Day 29
Hide Description Recovery is defined as the first day on which the participant with a baseline score >= 4, satisfies categories 1, 2, or 3 from the 8-point ordinal scale including: 1) Non-hospitalized, no limitations on activities; 2) Non-hospitalized, limitations on activities/requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care for COVID-19; 5) Hospitalized, supplemental oxygen; 6) Hospitalized, on noninvasive ventilation; 7) Hospitalized, on IMV or ECMO; 8) Death.
Time Frame First dose date up to Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set were analyzed.
Arm/Group Title Remdesivir (RDV) Placebo
Hide Arm/Group Description:
Participants received continued SOC therapy together with RDV 200 mg IV infusion on Day 1 followed by RDV 100 mg IV infusion from Day 2 up to Day 5.
Participants received continued SOC therapy together with RDV matching placebo IV saline on Day 1 followed by RDV matching placebo IV saline from Day 2 up to Day 5.
Overall Number of Participants Analyzed 163 80
Measure Type: Number
Unit of Measure: percentage of participants
57.7 63.8
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Remdesivir (RDV), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2773
Comments The treatment effect p-value was calculated using Cochran-Mantel-Haenszel (CMH) analysis including baseline stratification factors.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Relative risk
Estimated Value 0.89
Confidence Interval (2-Sided) 95%
0.731 to 1.091
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Percentage of Participants With Recovery Independent of Further Worsening Through Day 29
Hide Description Recovery is defined as the first day on which the participant with a baseline score >= 4, satisfies categories 1, 2, or 3 from the 8-point ordinal scale including: 1) Non-hospitalized, no limitations on activities; 2) Non-hospitalized, limitations on activities/requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care for COVID-19; 5) Hospitalized, supplemental oxygen; 6) Hospitalized, on noninvasive ventilation; 7) Hospitalized, on IMV or ECMO; 8) Death.
Time Frame First dose date up to Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set were analyzed.
Arm/Group Title Remdesivir (RDV) Placebo
Hide Arm/Group Description:
Participants received continued SOC therapy together with RDV 200 mg IV infusion on Day 1 followed by RDV 100 mg IV infusion from Day 2 up to Day 5.
Participants received continued SOC therapy together with RDV matching placebo IV saline on Day 1 followed by RDV matching placebo IV saline from Day 2 up to Day 5.
Overall Number of Participants Analyzed 163 80
Measure Type: Number
Unit of Measure: percentage of participants
66.3 67.5
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Remdesivir (RDV), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7538
Comments The treatment effect p-value was calculated using CMH analysis including baseline stratification factors.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Relative risk
Estimated Value 0.97
Confidence Interval (2-Sided) 95%
0.819 to 1.155
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Percentage of Participants Experiencing Serious Adverse Events (SAEs)
Hide Description An SAE was defined as an event that, at any dose, results in the following: Death, a life-threatening situation, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, a congenital anomaly/birth defect, a medically important event or reaction which may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require intervention to prevent one of the other outcomes constituting SAEs.
Time Frame First dose date up to last dose date (Maximum: 5 days) plus 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
Arm/Group Title Remdesivir (RDV) Placebo
Hide Arm/Group Description:
Participants received continued SOC therapy together with RDV 200 mg IV infusion on Day 1 followed by RDV 100 mg IV infusion from Day 2 up to Day 5.
Participants received continued SOC therapy together with RDV matching placebo IV saline on Day 1 followed by RDV matching placebo IV saline from Day 2 up to Day 5.
Overall Number of Participants Analyzed 163 80
Measure Type: Number
Unit of Measure: percentage of participants
50.3 50.0
12.Secondary Outcome
Title Percentage of Participants Who Permanently Discontinued Investigational Drug Due to Adverse Events (AEs)
Hide Description An AE is any untoward medical occurrence in a clinical study participant administered an investigational drug, which does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of an investigational drug, whether or not the AE is considered related to the investigational drug.
Time Frame First dose date up to last dose date (Maximum: 5 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Safety Analysis Set were analyzed.
Arm/Group Title Remdesivir (RDV) Placebo
Hide Arm/Group Description:
Participants received continued SOC therapy together with RDV 200 mg IV infusion on Day 1 followed by RDV 100 mg IV infusion from Day 2 up to Day 5.
Participants received continued SOC therapy together with RDV matching placebo IV saline on Day 1 followed by RDV matching placebo IV saline from Day 2 up to Day 5.
Overall Number of Participants Analyzed 163 80
Measure Type: Number
Unit of Measure: percentage of participants
4.9 1.3
Time Frame All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
Adverse Event Reporting Description

All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.

Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
 
Arm/Group Title Remdesivir (RDV) Placebo
Hide Arm/Group Description Participants received continued SOC therapy together with RDV 200 mg IV infusion on Day 1 followed by RDV 100 mg IV infusion from Day 2 up to Day 5. Participants received continued SOC therapy together with RDV matching placebo IV saline on Day 1 followed by RDV matching placebo IV saline from Day 2 up to Day 5.
All-Cause Mortality
Remdesivir (RDV) Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   55/166 (33.13%)   26/83 (31.33%) 
Hide Serious Adverse Events
Remdesivir (RDV) Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   82/163 (50.31%)   40/80 (50.00%) 
Blood and lymphatic system disorders     
Anaemia † 1  1/163 (0.61%)  0/80 (0.00%) 
Pancytopenia † 1  0/163 (0.00%)  1/80 (1.25%) 
Cardiac disorders     
Acute myocardial infarction † 1  1/163 (0.61%)  0/80 (0.00%) 
Atrial fibrillation † 1  3/163 (1.84%)  0/80 (0.00%) 
Atrial flutter † 1  1/163 (0.61%)  0/80 (0.00%) 
Atrioventricular block † 1  1/163 (0.61%)  0/80 (0.00%) 
Bradycardia † 1  2/163 (1.23%)  0/80 (0.00%) 
Cardiac arrest † 1  8/163 (4.91%)  1/80 (1.25%) 
Cardiac failure † 1  2/163 (1.23%)  0/80 (0.00%) 
Cardiac failure acute † 1  2/163 (1.23%)  1/80 (1.25%) 
Cardiac failure congestive † 1  2/163 (1.23%)  0/80 (0.00%) 
Cardiac ventricular thrombosis † 1  0/163 (0.00%)  1/80 (1.25%) 
Cardio-respiratory arrest † 1  2/163 (1.23%)  3/80 (3.75%) 
Cardiogenic shock † 1  1/163 (0.61%)  0/80 (0.00%) 
Pulseless electrical activity † 1  3/163 (1.84%)  0/80 (0.00%) 
Supraventricular tachycardia † 1  2/163 (1.23%)  0/80 (0.00%) 
Ventricular tachycardia † 1  1/163 (0.61%)  0/80 (0.00%) 
Endocrine disorders     
Adrenal insufficiency † 1  1/163 (0.61%)  0/80 (0.00%) 
Gastrointestinal disorders     
Duodenal perforation † 1  1/163 (0.61%)  0/80 (0.00%) 
Gastrointestinal haemorrhage † 1  2/163 (1.23%)  1/80 (1.25%) 
Intestinal perforation † 1  1/163 (0.61%)  0/80 (0.00%) 
Large intestinal haemorrhage † 1  1/163 (0.61%)  0/80 (0.00%) 
Lower gastrointestinal haemorrhage † 1  0/163 (0.00%)  1/80 (1.25%) 
Retroperitoneal haemorrhage † 1  2/163 (1.23%)  0/80 (0.00%) 
General disorders     
Death † 1  1/163 (0.61%)  0/80 (0.00%) 
General physical health deterioration † 1  1/163 (0.61%)  0/80 (0.00%) 
Multiple organ dysfunction syndrome † 1  4/163 (2.45%)  1/80 (1.25%) 
Pyrexia † 1  1/163 (0.61%)  0/80 (0.00%) 
Sudden death † 1  1/163 (0.61%)  0/80 (0.00%) 
Hepatobiliary disorders     
Hepatic ischaemia † 1  1/163 (0.61%)  0/80 (0.00%) 
Infections and infestations     
Aspergillus infection † 1  1/163 (0.61%)  0/80 (0.00%) 
Bacteraemia † 1  3/163 (1.84%)  0/80 (0.00%) 
Bacteroides bacteraemia † 1  0/163 (0.00%)  1/80 (1.25%) 
Bronchopulmonary aspergillosis † 1  1/163 (0.61%)  0/80 (0.00%) 
Covid-19 † 1  2/163 (1.23%)  3/80 (3.75%) 
Covid-19 pneumonia † 1  3/163 (1.84%)  1/80 (1.25%) 
Cystitis † 1  1/163 (0.61%)  0/80 (0.00%) 
Cytomegalovirus infection reactivation † 1  1/163 (0.61%)  1/80 (1.25%) 
Device related bacteraemia † 1  0/163 (0.00%)  1/80 (1.25%) 
Endocarditis bacterial † 1  1/163 (0.61%)  0/80 (0.00%) 
Gangrene † 1  0/163 (0.00%)  1/80 (1.25%) 
Peritonitis † 1  1/163 (0.61%)  0/80 (0.00%) 
Pneumocystis jirovecii infection † 1  1/163 (0.61%)  0/80 (0.00%) 
Pneumonia † 1  2/163 (1.23%)  0/80 (0.00%) 
Pneumonia bacterial † 1  2/163 (1.23%)  1/80 (1.25%) 
Postoperative abscess † 1  0/163 (0.00%)  1/80 (1.25%) 
Pulmonary sepsis † 1  1/163 (0.61%)  0/80 (0.00%) 
Pyelonephritis acute † 1  2/163 (1.23%)  0/80 (0.00%) 
Respiratory tract infection † 1  0/163 (0.00%)  1/80 (1.25%) 
Sepsis † 1  5/163 (3.07%)  2/80 (2.50%) 
Septic shock † 1  6/163 (3.68%)  2/80 (2.50%) 
Superinfection bacterial † 1  1/163 (0.61%)  0/80 (0.00%) 
Urinary tract infection † 1  1/163 (0.61%)  0/80 (0.00%) 
Injury, poisoning and procedural complications     
Dialysis related complication † 1  1/163 (0.61%)  0/80 (0.00%) 
Fall † 1  0/163 (0.00%)  1/80 (1.25%) 
Subdural haematoma † 1  2/163 (1.23%)  0/80 (0.00%) 
Subdural haemorrhage † 1  0/163 (0.00%)  1/80 (1.25%) 
Wound haemorrhage † 1  0/163 (0.00%)  1/80 (1.25%) 
Investigations     
Glomerular filtration rate abnormal † 1  0/163 (0.00%)  1/80 (1.25%) 
Lipase increased † 1  1/163 (0.61%)  0/80 (0.00%) 
Metabolism and nutrition disorders     
Acidosis † 1  1/163 (0.61%)  0/80 (0.00%) 
Hyperkalaemia † 1  0/163 (0.00%)  2/80 (2.50%) 
Hyperlipasaemia † 1  1/163 (0.61%)  0/80 (0.00%) 
Hypervolaemia † 1  0/163 (0.00%)  1/80 (1.25%) 
Lactic acidosis † 1  1/163 (0.61%)  0/80 (0.00%) 
Metabolic acidosis † 1  1/163 (0.61%)  2/80 (2.50%) 
Musculoskeletal and connective tissue disorders     
Arthralgia † 1  1/163 (0.61%)  1/80 (1.25%) 
Back pain † 1  1/163 (0.61%)  0/80 (0.00%) 
Nervous system disorders     
Dementia † 1  1/163 (0.61%)  0/80 (0.00%) 
Depressed level of consciousness † 1  2/163 (1.23%)  0/80 (0.00%) 
Ischaemic stroke † 1  1/163 (0.61%)  0/80 (0.00%) 
Metabolic encephalopathy † 1  1/163 (0.61%)  0/80 (0.00%) 
Syncope † 1  1/163 (0.61%)  0/80 (0.00%) 
Psychiatric disorders     
Delirium † 1  1/163 (0.61%)  0/80 (0.00%) 
Mental status changes † 1  1/163 (0.61%)  0/80 (0.00%) 
Renal and urinary disorders     
Acute kidney injury † 1  5/163 (3.07%)  1/80 (1.25%) 
End stage renal disease † 1  0/163 (0.00%)  1/80 (1.25%) 
Renal impairment † 1  0/163 (0.00%)  1/80 (1.25%) 
Respiratory, thoracic and mediastinal disorders     
Acute pulmonary oedema † 1  1/163 (0.61%)  2/80 (2.50%) 
Acute respiratory distress syndrome † 1  1/163 (0.61%)  1/80 (1.25%) 
Acute respiratory failure † 1  10/163 (6.13%)  4/80 (5.00%) 
Dyspnoea † 1  2/163 (1.23%)  0/80 (0.00%) 
Haemoptysis † 1  1/163 (0.61%)  0/80 (0.00%) 
Hypoxia † 1  6/163 (3.68%)  2/80 (2.50%) 
Organising pneumonia † 1  1/163 (0.61%)  0/80 (0.00%) 
Pleural effusion † 1  0/163 (0.00%)  1/80 (1.25%) 
Pneumomediastinum † 1  0/163 (0.00%)  2/80 (2.50%) 
Pneumothorax † 1  2/163 (1.23%)  3/80 (3.75%) 
Pulmonary embolism † 1  1/163 (0.61%)  0/80 (0.00%) 
Respiratory acidosis † 1  1/163 (0.61%)  0/80 (0.00%) 
Respiratory disorder † 1  0/163 (0.00%)  2/80 (2.50%) 
Respiratory distress † 1  3/163 (1.84%)  1/80 (1.25%) 
Respiratory failure † 1  7/163 (4.29%)  10/80 (12.50%) 
Vascular disorders     
Aortic stenosis † 1  0/163 (0.00%)  1/80 (1.25%) 
Hypertension † 1  0/163 (0.00%)  1/80 (1.25%) 
Hypertensive urgency † 1  0/163 (0.00%)  1/80 (1.25%) 
Hypotension † 1  7/163 (4.29%)  0/80 (0.00%) 
Malignant hypertension † 1  1/163 (0.61%)  0/80 (0.00%) 
Peripheral arterial occlusive disease † 1  0/163 (0.00%)  1/80 (1.25%) 
Shock † 1  2/163 (1.23%)  0/80 (0.00%) 
Shock haemorrhagic † 1  0/163 (0.00%)  1/80 (1.25%) 
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%
Remdesivir (RDV) Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   60/163 (36.81%)   34/80 (42.50%) 
Blood and lymphatic system disorders     
Anaemia † 1  10/163 (6.13%)  1/80 (1.25%) 
Cardiac disorders     
Atrial fibrillation † 1  7/163 (4.29%)  4/80 (5.00%) 
Gastrointestinal disorders     
Constipation † 1  12/163 (7.36%)  7/80 (8.75%) 
Nausea † 1  12/163 (7.36%)  3/80 (3.75%) 
Metabolism and nutrition disorders     
Hyperglycaemia † 1  7/163 (4.29%)  5/80 (6.25%) 
Hyperkalaemia † 1  13/163 (7.98%)  1/80 (1.25%) 
Hypoglycaemia † 1  8/163 (4.91%)  4/80 (5.00%) 
Hypokalaemia † 1  5/163 (3.07%)  7/80 (8.75%) 
Hypomagnesaemia † 1  3/163 (1.84%)  4/80 (5.00%) 
Musculoskeletal and connective tissue disorders     
Back pain † 1  2/163 (1.23%)  4/80 (5.00%) 
Nervous system disorders     
Headache † 1  3/163 (1.84%)  4/80 (5.00%) 
Psychiatric disorders     
Agitation † 1  5/163 (3.07%)  4/80 (5.00%) 
Anxiety † 1  5/163 (3.07%)  7/80 (8.75%) 
Vascular disorders     
Hypertension † 1  4/163 (2.45%)  6/80 (7.50%) 
Hypotension † 1  12/163 (7.36%)  4/80 (5.00%) 
1
Term from vocabulary, MedDRA (25.0)
†
Indicates events were collected by systematic assessment
[Not Specified]
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.

After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:

  • The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or
  • The study has been completed at all study sites for at least 2 years.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Gilead Clinical Study Information Center
Organization: Gilead Sciences
Phone: 1-833-445-3230 (GILEAD-0)
EMail: GileadClinicalTrials@gilead.com
Layout table for additonal information
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT04745351    
Other Study ID Numbers: GS-US-540-5912
2020-005416-22 ( EudraCT Number )
DOH-27-012022-4779 ( Registry Identifier: South African Clinical Trials Register )
First Submitted: February 8, 2021
First Posted: February 9, 2021
Results First Submitted: April 18, 2023
Results First Posted: May 12, 2023
Last Update Posted: May 12, 2023