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A Study of a Potential Oral Treatment to Prevent COVID-19 in Adults Who Are Exposed to Household Member(s) With a Confirmed Symptomatic COVID-19 Infection

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: NCT05047601
Recruitment Status : Completed
First Posted : September 17, 2021
Results First Posted : May 6, 2023
Last Update Posted : May 6, 2023
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition COVID-19
Interventions Drug: PF-07321332
Drug: Placebo for PF-07321332
Drug: Placebo for Ritonavir
Drug: Ritonavir
Enrollment 2954
Recruitment Details Participants who had a negative screening severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) rapid antigen test result and were asymptomatic household contacts of individuals who were symptomatic and recently tested positive for SARS-CoV-2, were included in the study.
Pre-assignment Details A total of 2880 participants were screened. Out of which, 122 participants were screen failures. 22 participants were not screen failures and were not randomized. 2736 participants were randomized and 2721 participants received study drug.
Arm/Group Title Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days Placebo
Hide Arm/Group Description Participants were randomized to receive nirmatrelvir 300 milligrams (mg) and ritonavir 100 mg orally every 12 hours from Day 1 to 5, followed by matching placebo every 12 hours from Day 6 through Day 10. Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 10. Participants were randomized to receive placebo matched to nirmatrelvir/ritonavir every 12 hours for 10 days from Day 1 through Day 10.
Period Title: Overall Study
Started 921 917 898
Treated 913 911 897
Completed 877 864 863
Not Completed 44 53 35
Reason Not Completed
Lost to Follow-up             9             11             7
Withdrawal by Subject             25             36             23
Other             10             6             5
Arm/Group Title Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days Placebo Total
Hide Arm/Group Description Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 5, followed by matching placebo every 12 hours from Day 6 through Day 10. Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 10. Participants were randomized to receive placebo matched to nirmatrelvir/ritonavir every 12 hours for 10 days from Day 1 through Day 10. Total of all reporting groups
Overall Number of Baseline Participants 921 917 898 2736
Hide Baseline Analysis Population Description
FAS (Full Analysis Set) included all participants randomly assigned to study intervention regardless of whether or not study intervention was administered.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 921 participants 917 participants 898 participants 2736 participants
43.92  (14.88) 42.85  (15.02) 42.39  (14.36) 43.06  (14.77)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 921 participants 917 participants 898 participants 2736 participants
Female
502
  54.5%
479
  52.2%
474
  52.8%
1455
  53.2%
Male
419
  45.5%
438
  47.8%
424
  47.2%
1281
  46.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 921 participants 917 participants 898 participants 2736 participants
Hispanic or Latino
664
  72.1%
642
  70.0%
643
  71.6%
1949
  71.2%
Not Hispanic or Latino
257
  27.9%
275
  30.0%
255
  28.4%
787
  28.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 921 participants 917 participants 898 participants 2736 participants
American Indian or Alaska Native
58
   6.3%
52
   5.7%
49
   5.5%
159
   5.8%
Asian
8
   0.9%
15
   1.6%
11
   1.2%
34
   1.2%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
139
  15.1%
136
  14.8%
132
  14.7%
407
  14.9%
White
714
  77.5%
711
  77.5%
704
  78.4%
2129
  77.8%
More than one race
1
   0.1%
1
   0.1%
1
   0.1%
3
   0.1%
Unknown or Not Reported
1
   0.1%
2
   0.2%
1
   0.1%
4
   0.1%
1.Primary Outcome
Title Percentage of Participants Who Developed Symptomatic RT-PCR or RAT Confirmed SARS-CoV-2 Infection Through Day 14: Among Participants With Negative RT-PCR at Baseline
Hide Description Percentage of participants who developed symptomatic Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) or Rapid Antigen Test (RAT) confirmed SARS-Cov-2 infection were reported in this outcome measure. Index case was defined as participants with symptomatic COVID-19.
Time Frame From Day 1 to Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-To-Treat (mITT) population included all participants randomly assigned to study intervention who received at least 1 dose of study intervention and had a negative RT-PCR result at baseline.
Arm/Group Title Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days Placebo
Hide Arm/Group Description:
Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 5, followed by matching placebo every 12 hours from Day 6 through Day 10.
Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 10.
Participants were randomized to receive placebo matched to nirmatrelvir/ritonavir every 12 hours for 10 days from Day 1 through Day 10.
Overall Number of Participants Analyzed 844 830 840
Measure Type: Number
Unit of Measure: Percentage of participants
2.607 2.410 3.929
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1722
Comments [Not Specified]
Method Generalized estimating equation (GEE)
Comments Model included the fixed effects of treatment, geographic regions and presence of risk factors. Compound symmetry variance-covariance structure.
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.702
Confidence Interval (2-Sided) 95%
0.422 to 1.167
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1163
Comments [Not Specified]
Method GEE
Comments Model included the fixed effects of treatment, geographic regions and presence of risk factors. Compound symmetry variance-covariance structure.
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.645
Confidence Interval (2-Sided) 95%
0.373 to 1.115
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious AEs and AEs Leading to Study and Study Drug Discontinuation
Hide Description An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening ; required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity ; congenital anomaly/birth defect; or that was considered as an important medical event. TEAEs were defined as events that started on or after the study medication start date and time. AEs included both serious and all non-serious adverse events. AEs that led to study discontinuation and AEs that led to discontinuation of study intervention and then continued study were also reported in this outcome measure.
Time Frame From start of study intervention (Day 1) up to end of safety follow-up (Day 38)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants randomly assigned to study intervention and who received at least 1 dose of study intervention.
Arm/Group Title Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days Placebo
Hide Arm/Group Description:
Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 5, followed by matching placebo every 12 hours from Day 6 through Day 10.
Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 10.
Participants were randomized to receive placebo matched to nirmatrelvir/ritonavir every 12 hours for 10 days from Day 1 through Day 10.
Overall Number of Participants Analyzed 912 911 898
Measure Type: Count of Participants
Unit of Measure: Participants
TEAEs
218
  23.9%
212
  23.3%
195
  21.7%
SAEs
3
   0.3%
1
   0.1%
2
   0.2%
AEs led to discontinuation of study
0
   0.0%
0
   0.0%
0
   0.0%
AEs led to discontinue study intervention and continued study
10
   1.1%
11
   1.2%
14
   1.6%
3.Secondary Outcome
Title Percentage of Participants Who Developed Symptomatic RT-PCR or RAT Confirmed SARS-CoV-2 Infection Through Day 14: Among Participants With Negative RT-PCR at Baseline With Increased Risk of Severe COVID-19 Illness
Hide Description Percentage of participants who had a symptomatic RT-PCR or RAT confirmed SARS-Cov-2 infection were reported in this outcome measure. The risk factors associated with severe covid-19 illness included age greater than or equal to 60 years, body mass index greater than 25, social history of smoking and presence of comorbidities. Index case was defined as participants with symptomatic COVID-19.
Time Frame From Day 1 to Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-To-Treat (mITT2) population included all participants randomly assigned to study intervention who received at least 1 dose of study intervention and had a negative RT-PCR result at baseline and were at increased risk of severe COVID-19 illness.
Arm/Group Title Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days Placebo
Hide Arm/Group Description:
Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 5, followed by matching placebo every 12 hours from Day 6 through Day 10.
Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 10.
Participants were randomized to receive placebo matched to nirmatrelvir/ritonavir every 12 hours for 10 days from Day 1 through Day 10.
Overall Number of Participants Analyzed 627 605 606
Measure Type: Number
Unit of Measure: Percentage of participants
2.871 2.645 3.465
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6766
Comments [Not Specified]
Method GEE
Comments Model included the fixed effects of treatment, geographic regions. Compound symmetry variance-covariance structure.
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.880
Confidence Interval (2-Sided) 95%
0.484 to 1.602
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5070
Comments [Not Specified]
Method GEE
Comments Model included the fixed effects of treatment, geographic regions. Compound symmetry variance-covariance structure.
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.809
Confidence Interval (2-Sided) 95%
0.433 to 1.512
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Participants With COVID-19 Related Hospitalization or Death From Any Cause Through Day 28: Among Participants With Negative RT-PCR at Baseline With Increased Risk of Severe COVID-19 Illness
Hide Description The risk factors associated with severe covid-19 illness included age greater than or equal to 60 years, body mass index greater than 25, social history of smoking and presence of comorbidities.
Time Frame From Day 1 to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
mITT2 population included all participants randomly assigned to study intervention who received at least 1 dose of study intervention and had a negative RT-PCR result at baseline and were at increased risk of severe COVID-19 illness.
Arm/Group Title Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days Placebo
Hide Arm/Group Description:
Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 5, followed by matching placebo every 12 hours from Day 6 through Day 10.
Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 10.
Participants were randomized to receive placebo matched to nirmatrelvir/ritonavir every 12 hours for 10 days from Day 1 through Day 10.
Overall Number of Participants Analyzed 627 605 606
Measure Type: Number
Unit of Measure: Percentage of participants
0 0 0.165
5.Secondary Outcome
Title Percentage of Participants With Asymptomatic RT-PCR or RAT Confirmed SARS-CoV-2 Infection Through Day 14: Among Participants With Negative RT-PCR at Baseline
Hide Description Percentage of participants who had asymptomatic RT-PCR or RAT confirmed SARS-CoV-2 infection through day 14 among participants with negative RT-PCR at baseline were reported in this outcome measure. Index case was defined as participants with symptomatic COVID-19.
Time Frame From Day 1 to Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population included all participants randomly assigned to study intervention who received at least 1 dose of study intervention and had a negative RT-PCR result at baseline.
Arm/Group Title Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days Placebo
Hide Arm/Group Description:
Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 5, followed by matching placebo every 12 hours from Day 6 through Day 10.
Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 10.
Participants were randomized to receive placebo matched to nirmatrelvir/ritonavir every 12 hours for 10 days from Day 1 through Day 10.
Overall Number of Participants Analyzed 844 830 840
Measure Type: Number
Unit of Measure: Percentage of participants
2.014 1.928 3.095
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1869
Comments [Not Specified]
Method GEE
Comments Model included the fixed effects of treatment, geographic regions and presence of risk factors. Compound symmetry variance-covariance structure.
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.672
Confidence Interval (2-Sided) 95%
0.373 to 1.213
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1221
Comments [Not Specified]
Method GEE
Comments Model included the fixed effects of treatment, geographic regions and presence of risk factors. Compound symmetry variance-covariance structure.
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.633
Confidence Interval (2-Sided) 95%
0.355 to 1.130
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Time to RT-PCR or RAT Confirmed SARS-CoV-2 Infection Through Day 14: Among Participants With Negative RT-PCR at Baseline
Hide Description Number of days between first dose and confirmation of the SARS-CoV-2 infection by RT-PCR or RAT was reported in this outcome measure.
Time Frame From Day 1 to Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population included all participants randomly assigned to study intervention who received at least 1 dose of study intervention and had a negative RT-PCR result at baseline.
Arm/Group Title Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days Placebo
Hide Arm/Group Description:
Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 5, followed by matching placebo every 12 hours from Day 6 through Day 10.
Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 10.
Participants were randomized to receive placebo matched to nirmatrelvir/ritonavir every 12 hours for 10 days from Day 1 through Day 10.
Overall Number of Participants Analyzed 844 830 840
Median (95% Confidence Interval)
Unit of Measure: Days
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
Median and the corresponding 95% CI could not be calculated as the proportion of participants who achieved the event were low.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0368
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0186
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
7.Secondary Outcome
Title Percentage of Participants With Symptomatic RT-PCR or RAT Confirmed SARS-CoV-2 Infection Through Day 14: Among Participants With Positive RT-PCR at Baseline
Hide Description Percentage of participants with a positive RT-PCR result at baseline who had a symptomatic SARS-CoV-2 infection confirmed by RAT or RT-PCR through Day 14 were reported in this outcome measure. Index case was defined as participants with symptomatic COVID-19.
Time Frame From Day 1 to Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
mITT1 population included all participants randomly assigned to study intervention who received at least 1 dose of study intervention and had a positive RT-PCR result at baseline.
Arm/Group Title Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days Placebo
Hide Arm/Group Description:
Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 5, followed by matching placebo every 12 hours from Day 6 through Day 10.
Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 10.
Participants were randomized to receive placebo matched to nirmatrelvir/ritonavir every 12 hours for 10 days from Day 1 through Day 10.
Overall Number of Participants Analyzed 38 48 29
Measure Type: Number
Unit of Measure: Percentage of participants
28.947 45.833 37.931
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4126
Comments [Not Specified]
Method GEE
Comments Model included the fixed effects of treatment, geographic regions and presence of risk factors. Compound symmetry variance-covariance structure.
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.750
Confidence Interval (2-Sided) 95%
0.378 to 1.491
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4273
Comments [Not Specified]
Method GEE
Comments Model included the fixed effects of treatment, geographic regions and presence of risk factors. Compound symmetry variance-covariance structure.
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.244
Confidence Interval (2-Sided) 95%
0.725 to 2.135
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Percentage of Participants With Symptomatic RT-PCR or RAT Confirmed SARS-CoV-2 Infection Through Day 14: Among Participants With Negative, Positive or Missing RT-PCR at Baseline
Hide Description Percentage of participants with a negative, positive, or missing RT-PCR result at baseline, who had a symptomatic SARS-CoV-2 infection confirmed by RAT or RT-PCR through Day 14 were reported in this outcome measure. Index case was defined as participants with symptomatic COVID-19.
Time Frame From Day 1 to Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-To-Treat (mITT3) population included all participants randomly assigned to study intervention who received at least 1 dose of study intervention and had a negative, positive or missing RT-PCR result at baseline.
Arm/Group Title Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days Placebo
Hide Arm/Group Description:
Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 5, followed by matching placebo every 12 hours from Day 6 through Day 10.
Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 10.
Participants were randomized to receive placebo matched to nirmatrelvir/ritonavir every 12 hours for 10 days from Day 1 through Day 10.
Overall Number of Participants Analyzed 889 887 873
Measure Type: Number
Unit of Measure: Percentage of Participants
3.712 4.848 5.269
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1333
Comments [Not Specified]
Method GEE
Comments Model included the fixed effects of treatment, geographic regions and presence of risk factors. Compound symmetry variance-covariance structure.
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.726
Confidence Interval (2-Sided) 95%
0.478 to 1.103
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8088
Comments [Not Specified]
Method GEE
Comments Model included the fixed effects of treatment, geographic regions and presence of risk factors. Compound symmetry variance-covariance structure.
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.953
Confidence Interval (2-Sided) 95%
0.645 to 1.408
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Percentage of Participants With no, Mild, Moderate, or Severe Signs and Symptoms Attributed to COVID-19 Through Day 28: Among Participants With Negative RT-PCR at Baseline
Hide Description Participants were categorized according to severity of signs and symptoms as no, mild, moderate, severe in this outcome measure. The 12 signs and symptoms included stuffy or runny nose, sore throat, shortness of breath or difficulty breathing, cough, low energy or tiredness, muscle or body aches, headache, chills or shivering, feeling hot or feverish, nausea, vomiting, diarrhea. Participants recorded their daily severity rating of their symptoms over the past 24 hours based on a 4-point scale in which 0 was reported if no symptoms were present; 1 if mild; 2 if moderate; and 3 if severe.
Time Frame From Day 1 to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population included all participants randomly assigned to study intervention who received at least 1 dose of study intervention and had a negative RT-PCR result at baseline.
Arm/Group Title Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days Placebo
Hide Arm/Group Description:
Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 5, followed by matching placebo every 12 hours from Day 6 through Day 10.
Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 10.
Participants were randomized to receive placebo matched to nirmatrelvir/ritonavir every 12 hours for 10 days from Day 1 through Day 10.
Overall Number of Participants Analyzed 844 830 840
Measure Type: Number
Unit of Measure: Percentage of participants
No 81.517 83.373 81.667
Mild 7.820 8.193 7.619
Moderate 6.872 5.060 7.143
Severe 2.133 2.048 2.738
Missing 1.659 1.325 0.833
10.Secondary Outcome
Title Number of Days of Symptomatic RT-PCR or RAT Confirmed SARS-CoV- 2 Infection Through Day 28: Among Participants With Negative RT-PCR at Baseline
Hide Description This outcome measure has been reported in terms of number of participants according to days of symptomatic SARS-CoV-2 infection through Day 28.
Time Frame From Day 1 to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population included all participants randomly assigned to study intervention who received at least 1 dose of study intervention and had a negative RT-PCR result at baseline. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
Arm/Group Title Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days Placebo
Hide Arm/Group Description:
Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 5, followed by matching placebo every 12 hours from Day 6 through Day 10.
Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 10.
Participants were randomized to receive placebo matched to nirmatrelvir/ritonavir every 12 hours for 10 days from Day 1 through Day 10.
Overall Number of Participants Analyzed 22 20 33
Measure Type: Count of Participants
Unit of Measure: Participants
1 Day of Symptoms
1
   4.5%
7
  35.0%
2
   6.1%
2 Days of Symptoms
2
   9.1%
0
   0.0%
1
   3.0%
3 Days of Symptoms
0
   0.0%
1
   5.0%
4
  12.1%
4 Days of Symptoms
5
  22.7%
0
   0.0%
2
   6.1%
5 Days of Symptoms
1
   4.5%
3
  15.0%
3
   9.1%
6 Days of Symptoms
0
   0.0%
1
   5.0%
3
   9.1%
7 Days of Symptoms
3
  13.6%
4
  20.0%
4
  12.1%
8 Days of Symptoms
2
   9.1%
0
   0.0%
5
  15.2%
9 Days of Symptoms
0
   0.0%
1
   5.0%
1
   3.0%
10 Days of Symptoms
0
   0.0%
0
   0.0%
1
   3.0%
11 Days of Symptoms
0
   0.0%
1
   5.0%
1
   3.0%
12 Days of Symptoms
2
   9.1%
0
   0.0%
4
  12.1%
13 Days of Symptoms
1
   4.5%
1
   5.0%
2
   6.1%
14 Days of Symptoms
1
   4.5%
1
   5.0%
0
   0.0%
18 Days of Symptoms
2
   9.1%
0
   0.0%
0
   0.0%
20 Days of Symptoms
1
   4.5%
0
   0.0%
0
   0.0%
26 Days of Symptoms
1
   4.5%
0
   0.0%
0
   0.0%
11.Secondary Outcome
Title Plasma Concentration Versus Time Summary of Nirmatrelvir (PF-07321332)
Hide Description [Not Specified]
Time Frame Day 1: 1 hour post dose; Day 5: 2 hours pre-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants randomly assigned to study intervention and who received at least 1 dose of study intervention. This outcome measure was not planned to be analyzed for placebo arm. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure and ''Number Analyzed'' signifies participants evaluable at specific time points.
Arm/Group Title Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days
Hide Arm/Group Description:
Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 5, followed by matching placebo every 12 hours from Day 6 through Day 10.
Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 10.
Overall Number of Participants Analyzed 476 476
Mean (Standard Deviation)
Unit of Measure: Nanograms per milliliter
Day 1 (1 hour post-dose) Number Analyzed 159 participants 156 participants
1489  (1481.4) 1472  (1488.2)
Day 5 (2 hours pre-dose) Number Analyzed 476 participants 476 participants
1688  (2093.3) 1657  (2068.2)
12.Secondary Outcome
Title Percentage of Participants With Death Event Through Day 38: Among Participants With Negative RT-PCR at Baseline
Hide Description Percentage of participants with death (all-cause) event were reported in this outcome measure.
Time Frame From Day 1 to Day 38
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population included all participants randomly assigned to study intervention who received at least 1 dose of study intervention and had a negative RT-PCR result at baseline.
Arm/Group Title Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days Placebo
Hide Arm/Group Description:
Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 5, followed by matching placebo every 12 hours from Day 6 through Day 10.
Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 10.
Participants were randomized to receive placebo matched to nirmatrelvir/ritonavir every 12 hours for 10 days from Day 1 through Day 10.
Overall Number of Participants Analyzed 844 830 840
Measure Type: Number
Unit of Measure: Percentage of participants
0 0 0
13.Secondary Outcome
Title Viral Load in Nasal Samples Over Time: Among Participants With Negative RT-PCR at Baseline
Hide Description Nasal samples were collected to estimate the viral load in terms of logarithm to base 10 (log10) copies per milliliter in participants with negative RT-PCR at baseline and were reported in this outcome measure.
Time Frame From Day 1 to Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population included all participants randomly assigned to study intervention who received at least 1 dose of study intervention and had a negative RT-PCR result at baseline. Here 'Number Analyzed' signifies participants evaluable for the specific time points.
Arm/Group Title Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days Placebo
Hide Arm/Group Description:
Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 5, followed by matching placebo every 12 hours from Day 6 through Day 10.
Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 10.
Participants were randomized to receive placebo matched to nirmatrelvir/ritonavir every 12 hours for 10 days from Day 1 through Day 10.
Overall Number of Participants Analyzed 844 830 840
Mean (Standard Deviation)
Unit of Measure: Log 10 copies per milliliter
Day 1 Number Analyzed 844 participants 830 participants 840 participants
0.042  (0.265) 0.035  (0.241) 0.038  (0.253)
Day 2 Number Analyzed 810 participants 802 participants 809 participants
0.078  (0.523) 0.053  (0.409) 0.108  (0.611)
Day 3 Number Analyzed 823 participants 812 participants 812 participants
0.090  (0.586) 0.048  (0.374) 0.147  (0.760)
Day 4 Number Analyzed 820 participants 808 participants 813 participants
0.081  (0.537) 0.057  (0.409) 0.165  (0.859)
Day 5 Number Analyzed 736 participants 737 participants 742 participants
0.079  (0.528) 0.074  (0.573) 0.217  (1.063)
Day 6 Number Analyzed 817 participants 799 participants 812 participants
0.074  (0.575) 0.090  (0.670) 0.189  (0.978)
Day 7 Number Analyzed 815 participants 798 participants 806 participants
0.088  (0.586) 0.053  (0.536) 0.186  (0.883)
Day 8 Number Analyzed 814 participants 796 participants 805 participants
0.096  (0.627) 0.081  (0.669) 0.159  (0.860)
Day 9 Number Analyzed 810 participants 795 participants 807 participants
0.094  (0.672) 0.062  (0.596) 0.135  (0.784)
Day 10 Number Analyzed 733 participants 715 participants 714 participants
0.080  (0.616) 0.064  (0.590) 0.133  (0.725)
Day 11 Number Analyzed 797 participants 789 participants 793 participants
0.103  (0.673) 0.053  (0.511) 0.115  (0.707)
Day 12 Number Analyzed 803 participants 783 participants 798 participants
0.106  (0.748) 0.051  (0.447) 0.103  (0.662)
Day 13 Number Analyzed 797 participants 791 participants 794 participants
0.085  (0.642) 0.052  (0.425) 0.117  (0.714)
Day 14 Number Analyzed 696 participants 670 participants 686 participants
0.108  (0.717) 0.035  (0.386) 0.146  (0.798)
14.Secondary Outcome
Title Viral Load in Nasal Samples Over Time: Among Participants With Positive RT-PCR at Baseline
Hide Description Nasal samples were collected to estimate the viral load in terms of logarithm to base 10 (log10) copies per milliliter in participants with positive RT-PCR at baseline and were reported in this outcome measure.
Time Frame From Day 1 to Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
mITT1 population included all participants randomly assigned to study intervention who received at least 1 dose of study intervention and had a positive RT-PCR result at baseline. Here 'Number Analyzed' signifies participants evaluable for the specific time points.
Arm/Group Title Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days Placebo
Hide Arm/Group Description:
Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 5, followed by matching placebo every 12 hours from Day 6 through Day 10.
Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 10.
Participants were randomized to receive placebo matched to nirmatrelvir/ritonavir every 12 hours for 10 days from Day 1 through Day 10.
Overall Number of Participants Analyzed 38 48 29
Mean (Standard Deviation)
Unit of Measure: Log 10 copies per milliliter
Day 1 Number Analyzed 38 participants 48 participants 29 participants
4.870  (2.041) 4.470  (1.542) 4.837  (1.577)
Day 2 Number Analyzed 38 participants 45 participants 28 participants
3.286  (2.534) 2.724  (2.208) 3.104  (2.909)
Day 3 Number Analyzed 38 participants 46 participants 28 participants
2.880  (2.641) 2.051  (2.212) 3.255  (2.702)
Day 4 Number Analyzed 36 participants 47 participants 28 participants
2.600  (2.427) 1.514  (2.064) 2.721  (2.640)
Day 5 Number Analyzed 35 participants 43 participants 27 participants
1.470  (2.057) 1.413  (1.745) 2.994  (2.677)
Day 6 Number Analyzed 38 participants 44 participants 28 participants
1.065  (1.656) 0.997  (1.696) 2.466  (2.561)
Day 7 Number Analyzed 37 participants 45 participants 28 participants
1.199  (1.747) 0.913  (1.762) 1.478  (2.212)
Day 8 Number Analyzed 37 participants 45 participants 28 participants
1.212  (1.829) 0.942  (1.908) 1.072  (1.663)
Day 9 Number Analyzed 38 participants 44 participants 28 participants
1.169  (1.852) 0.766  (1.858) 1.103  (1.545)
Day 10 Number Analyzed 35 participants 45 participants 28 participants
0.819  (1.656) 0.541  (1.605) 0.965  (1.514)
Day 11 Number Analyzed 36 participants 44 participants 28 participants
0.623  (1.170) 0.603  (1.044) 0.707  (1.116)
Day 12 Number Analyzed 37 participants 44 participants 28 participants
0.532  (1.136) 0.670  (1.204) 0.436  (0.919)
Day 13 Number Analyzed 36 participants 45 participants 26 participants
0.413  (1.098) 0.313  (1.018) 0.361  (0.770)
Day 14 Number Analyzed 31 participants 40 participants 25 participants
0.284  (1.040) 0.345  (0.808) 0.358  (0.735)
15.Secondary Outcome
Title Number of Days of Hospitalization and Intensive Care Unit (ICU) Stay: Among Participants With Negative RT-PCR at Baseline
Hide Description This outcome measure has been presented in terms of participants according to number of days of hospitalization and in ICU as 0 days and more than or equal to 1 day.
Time Frame From Day 1 to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population included all participants randomly assigned to study intervention who received at least 1 dose of study intervention and had a negative RT-PCR result at baseline.
Arm/Group Title Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days Placebo
Hide Arm/Group Description:
Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 5, followed by matching placebo every 12 hours from Day 6 through Day 10.
Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 10.
Participants were randomized to receive placebo matched to nirmatrelvir/ritonavir every 12 hours for 10 days from Day 1 through Day 10.
Overall Number of Participants Analyzed 844 830 840
Measure Type: Count of Participants
Unit of Measure: Participants
ICU Visits: 0 Day
844
 100.0%
830
 100.0%
840
 100.0%
ICU Visits: More than or equal to 1 day
0
   0.0%
0
   0.0%
0
   0.0%
Hospitalization Visits: 0 Day
844
 100.0%
830
 100.0%
839
  99.9%
Hospitalization Visits: More than or equal to 1 day
0
   0.0%
0
   0.0%
1
   0.1%
16.Secondary Outcome
Title Number of COVID-19 Related Medical Visits Through Day 28: Among Participants With Negative RT-PCR at Baseline
Hide Description In this outcome measure number of COVID-19 related medical visits per day were reported. Number of medical visits per day = number of medical visits/number of days follow up through day 28 visit or the last collection date on or before day 28, if day 28 visit was missing.
Time Frame From Day 1 to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population included all participants randomly assigned to study intervention who received at least 1 dose of study intervention and had a negative RT-PCR result at baseline.
Arm/Group Title Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days Placebo
Hide Arm/Group Description:
Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 5, followed by matching placebo every 12 hours from Day 6 through Day 10.
Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 10.
Participants were randomized to receive placebo matched to nirmatrelvir/ritonavir every 12 hours for 10 days from Day 1 through Day 10.
Overall Number of Participants Analyzed 844 830 840
Mean (Standard Deviation)
Unit of Measure: Medical visits per day
0.0067  (0.0200) 0.0057  (0.0201) 0.0066  (0.0182)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7991
Comments [Not Specified]
Method Negative binomial regression model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Ratio
Estimated Value 0.969
Confidence Interval (2-Sided) 95%
0.758 to 1.238
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1985
Comments [Not Specified]
Method Negative binomial regression model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Ratio
Estimated Value 0.847
Confidence Interval (2-Sided) 95%
0.657 to 1.091
Estimation Comments [Not Specified]
Time Frame From Day 1 to Day 38
Adverse Event Reporting Description Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
 
Arm/Group Title Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days Placebo
Hide Arm/Group Description Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 5, followed by matching placebo every 12 hours from Day 6 through Day 10. Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 10. Participants were randomized to receive placebo matched to nirmatrelvir/ritonavir every 12 hours for 10 days from Day 1 through Day 10.
All-Cause Mortality
Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/912 (0.00%)   0/911 (0.00%)   0/898 (0.00%) 
Hide Serious Adverse Events
Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/912 (0.33%)   1/911 (0.11%)   2/898 (0.22%) 
Hepatobiliary disorders       
Cholecystitis acute * 1  1/912 (0.11%)  0/911 (0.00%)  0/898 (0.00%) 
Infections and infestations       
COVID-19 pneumonia * 1  1/912 (0.11%)  1/911 (0.11%)  1/898 (0.11%) 
Injury, poisoning and procedural complications       
Overdose * 1  0/912 (0.00%)  0/911 (0.00%)  1/898 (0.11%) 
Road traffic accident * 1  1/912 (0.11%)  0/911 (0.00%)  0/898 (0.00%) 
Tibia fracture * 1  1/912 (0.11%)  0/911 (0.00%)  0/898 (0.00%) 
1
Term from vocabulary, MedDRA v24.1
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   176/912 (19.30%)   173/911 (18.99%)   152/898 (16.93%) 
Gastrointestinal disorders       
Diarrhoea * 1  23/912 (2.52%)  22/911 (2.41%)  15/898 (1.67%) 
Nausea * 1  16/912 (1.75%)  12/911 (1.32%)  14/898 (1.56%) 
General disorders       
Asthenia * 1  10/912 (1.10%)  7/911 (0.77%)  17/898 (1.89%) 
Infections and infestations       
COVID-19 * 1  27/912 (2.96%)  26/911 (2.85%)  36/898 (4.01%) 
Nasopharyngitis * 1  13/912 (1.43%)  9/911 (0.99%)  6/898 (0.67%) 
Upper respiratory tract infection * 1  20/912 (2.19%)  17/911 (1.87%)  18/898 (2.00%) 
Investigations       
Activated partial thromboplastin time prolonged * 1  11/912 (1.21%)  14/911 (1.54%)  22/898 (2.45%) 
Alanine aminotransferase increased * 1  2/912 (0.22%)  6/911 (0.66%)  11/898 (1.22%) 
Blood creatine phosphokinase increased * 1  12/912 (1.32%)  15/911 (1.65%)  13/898 (1.45%) 
Blood thyroid stimulating hormone increased * 1  11/912 (1.21%)  8/911 (0.88%)  10/898 (1.11%) 
Fibrin D dimer increased * 1  18/912 (1.97%)  13/911 (1.43%)  4/898 (0.45%) 
Nervous system disorders       
Dysgeusia * 1  54/912 (5.92%)  62/911 (6.81%)  6/898 (0.67%) 
Headache * 1  15/912 (1.64%)  17/911 (1.87%)  29/898 (3.23%) 
Respiratory, thoracic and mediastinal disorders       
Cough * 1  10/912 (1.10%)  2/911 (0.22%)  12/898 (1.34%) 
Nasal congestion * 1  4/912 (0.44%)  3/911 (0.33%)  10/898 (1.11%) 
1
Term from vocabulary, MedDRA v24.1
*
Indicates events were collected by non-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.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT05047601    
Other Study ID Numbers: C4671006
2021-002894-24 ( EudraCT Number )
EPIC-PEP ( Other Identifier: Alias Study Number )
First Submitted: September 1, 2021
First Posted: September 17, 2021
Results First Submitted: April 11, 2023
Results First Posted: May 6, 2023
Last Update Posted: May 6, 2023