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EPIC-HR: Study of Oral PF-07321332/Ritonavir Compared With Placebo in Nonhospitalized High Risk Adults 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: NCT04960202
Recruitment Status : Completed
First Posted : July 13, 2021
Results First Posted : February 9, 2023
Last Update Posted : February 9, 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: Treatment
Condition COVID-19
Interventions Drug: PF-07321332
Drug: Ritonavir
Drug: Placebo
Enrollment 2246
Recruitment Details  
Pre-assignment Details 2396 participants signed the informed consent form (ICF). Out of these 2396 participants, 137 participants were screen failures who did not meet the study criteria and were not enrolled. There were 13 participants who were not screen failure but not randomized due to withdrew consent or other reasons. A total of 2246 participants were assigned to a study treatment.
Arm/Group Title PF-07321332 300 mg + Ritonavir 100 mg Placebo
Hide Arm/Group Description Participants with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection received 300 milligrams (mg) PF-07321332 coadministered with 100 mg ritonavir orally, every 12 hours (q12h) for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24. Participants with SARS-CoV-2 infection received placebo orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.
Period Title: Overall Study
Started 1120 1126
Treated 1109 1115
Completed 1045 1039
Not Completed 75 87
Reason Not Completed
Other             12             10
Withdrawal by Subject             43             45
Lost to Follow-up             20             17
Death             0             15
Arm/Group Title PF-07321332 300 mg + Ritonavir 100 mg Placebo Total
Hide Arm/Group Description Participants with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection received 300 milligrams (mg) PF-07321332 coadministered with 100 mg ritonavir orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24. Participants with SARS-CoV-2 infection received placebo orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24. Total of all reporting groups
Overall Number of Baseline Participants 1120 1126 2246
Hide Baseline Analysis Population Description
Full analysis set included all participants randomly assigned to study intervention, whether or not administered the study intervention.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1120 participants 1126 participants 2246 participants
45.33  (15.40) 46.34  (15.51) 45.84  (15.46)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1120 participants 1126 participants 2246 participants
Female
554
  49.5%
544
  48.3%
1098
  48.9%
Male
566
  50.5%
582
  51.7%
1148
  51.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1120 participants 1126 participants 2246 participants
Hispanic or Latino
499
  44.6%
505
  44.8%
1004
  44.7%
Not Hispanic or Latino
616
  55.0%
614
  54.5%
1230
  54.8%
Unknown or Not Reported
5
   0.4%
7
   0.6%
12
   0.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1120 participants 1126 participants 2246 participants
American Indian or Alaska Native
96
   8.6%
95
   8.4%
191
   8.5%
Asian
154
  13.8%
160
  14.2%
314
  14.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
60
   5.4%
50
   4.4%
110
   4.9%
White
800
  71.4%
808
  71.8%
1608
  71.6%
More than one race
1
   0.1%
2
   0.2%
3
   0.1%
Unknown or Not Reported
9
   0.8%
11
   1.0%
20
   0.9%
1.Primary Outcome
Title Percentage of Participants With Covid-19 Related Hospitalization or Death From Any Cause Through Day 28- Modified Intent-To-Treat (mITT) Population
Hide Description Percentage of participants with COVID-19 related hospitalization or death from any cause during the first 28 days of the study was estimated using the Kaplan-Meier (KM) method. Using KM method, survival probability for each time interval was calculated as the number of participants surviving divided by the number of participants at risk. Participants who had the event, dropped out, or moved out were not counted as "at risk" i.e., participants who were lost were considered "censored" and were not counted in the denominator.
Time Frame From Day 1 to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population included all participants who were randomized and took at least one dose of study intervention, who at baseline did not receive nor were expected to receive COVID-19 therapeutic monoclonal antibody (mAb) treatment and were treated <=3 days of COVID-19 onset.
Arm/Group Title PF-07321332 300 mg + Ritonavir 100 mg Placebo
Hide Arm/Group Description:
Participants with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection received 300 milligrams (mg) PF-07321332 coadministered with 100 mg ritonavir orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.
Participants with SARS-CoV-2 infection received placebo orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.
Overall Number of Participants Analyzed 697 682
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
0.723
(0.302 to 1.729)
6.531
(4.901 to 8.676)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PF-07321332 300 mg + Ritonavir 100 mg, Placebo
Comments The difference of the percentage in the 2 treatment groups and its 95% confidence interval, and p-value based on Normal approximation of the data are presented.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Normal approximation
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage difference
Estimated Value -5.807
Confidence Interval (2-Sided) 95%
-7.777 to -3.837
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.005
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Hide Description An adverse event (AE) was any untoward medical occurrence in a participant, temporarily associated with the use of study intervention, whether or not considered related to the study intervention. Serious adverse event (SAE) was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/ incapacity; congenital anomaly/birth defect; a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic and other important medical events. AEs included both SAEs and all non-SAEs. An AE was considered as TEAE if the event started on or after start date of study intervention.
Time Frame From start of study intervention (Day 1) up to end of safety follow-up (Day 34)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set (SAS) included all participants who received at least one dose of study intervention.
Arm/Group Title PF-07321332 300 mg + Ritonavir 100 mg Placebo
Hide Arm/Group Description:
Participants with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection received 300 milligrams (mg) PF-07321332 coadministered with 100 mg ritonavir orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.
Participants with SARS-CoV-2 infection received placebo orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.
Overall Number of Participants Analyzed 1109 1115
Measure Type: Count of Participants
Unit of Measure: Participants
256
  23.1%
270
  24.2%
3.Secondary Outcome
Title Number of Participants With AEs Leading to Discontinuation and Serious Adverse Events (SAEs)
Hide Description An AE was any untoward medical occurrence in a participant, temporarily associated with the use of study treatment, whether or not considered related to the study treatment. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/ incapacity; congenital anomaly/birth defect; a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic and other important medical events.
Time Frame From start of study intervention (Day 1) up to end of safety follow-up (Day 34)
Hide Outcome Measure Data
Hide Analysis Population Description
SAS population included all participants who were randomized and took at least one dose of investigational product.
Arm/Group Title PF-07321332 300 mg + Ritonavir 100 mg Placebo
Hide Arm/Group Description:
Participants with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection received 300 milligrams (mg) PF-07321332 coadministered with 100 mg ritonavir orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.
Participants with SARS-CoV-2 infection received placebo orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.
Overall Number of Participants Analyzed 1109 1115
Measure Type: Count of Participants
Unit of Measure: Participants
AEs leading to study discontinuation
0
   0.0%
13
   1.2%
SAEs
19
   1.7%
74
   6.6%
4.Secondary Outcome
Title Percentage of Participants With Covid-19 Related Hospitalization or Death From Any Cause Through Day 28- Modified Intent-To-Treat 1 (mITT1) Population
Hide Description Percentage of participants with COVID-19 related hospitalization or death from any cause during the first 28 days of the study was estimated using the Kaplan-Meier method.
Time Frame From Day 1 to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
mITT1 population included all participants who were randomized and took at least one dose of study intervention and who at baseline did not receive nor were expected to receive COVID-19 therapeutic mAb treatment.
Arm/Group Title PF-07321332 300 mg + Ritonavir 100 mg Placebo
Hide Arm/Group Description:
Participants with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection received 300 milligrams (mg) PF-07321332 coadministered with 100 mg ritonavir orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.
Participants with SARS-CoV-2 infection received placebo orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.
Overall Number of Participants Analyzed 1039 1046
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
0.878
(0.458 to 1.680)
6.400
(5.063 to 8.075)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PF-07321332 300 mg + Ritonavir 100 mg, Placebo
Comments The difference of the percentage in the 2 treatment groups and its 95% confidence interval, and p-value based on Normal approximation of the data are presented.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Normal approximation
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage difference
Estimated Value -5.522
Confidence Interval (2-Sided) 95%
-7.122 to -3.923
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.816
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Time to Sustained Alleviation of All Targeted COVID-19 Signs and Symptoms Through Day 28- mITT Population
Hide Description Sustained alleviation of all targeted COVID-19 signs/symptoms was defined as the event occurring on the first 4 consecutive days when all symptoms scored as moderate or severe at the time of enrollment were scored as mild or absent and those scored mild or absent at the time of enrollment were scored as absent. The first day of the 4 consecutive-day period was considered date of first event. Time to sustained alleviation (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained alleviation (censored), time was calculated as censoring date (last date on which symptom alleviation was assessed) minus first dose date plus 1 or Day 25 whichever occurred first.
Time Frame From Day 1 (baseline) to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population included all participants who were randomized and took at least one dose of study intervention, who at baseline did not receive nor were expected to receive COVID-19 therapeutic mAb treatment and were treated <=3 days of COVID-19 onset. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Arm/Group Title PF-07321332 300 mg + Ritonavir 100 mg Placebo
Hide Arm/Group Description:
Participants with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection received 300 milligrams (mg) PF-07321332 coadministered with 100 mg ritonavir orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.
Participants with SARS-CoV-2 infection received placebo orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.
Overall Number of Participants Analyzed 686 674
Median (95% Confidence Interval)
Unit of Measure: Days
12.00
(12.00 to 13.00)
15.00
(13.00 to 16.00)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PF-07321332 300 mg + Ritonavir 100 mg, Placebo
Comments Analysis of treatment effect on time to sustained alleviation is based on Cox proportional hazard (PH) model with treatment and geographic region effects as independent variables, and baseline SARS-CoV-2 serology status and baseline viral load (<4 logarithm to base 10 [log10] copies/milliliter [mL], >=4 log10 copies/mL) as covariates.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments [Not Specified]
Method Cox Proportional Hazard Model
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.267
Confidence Interval (2-Sided) 95%
1.115 to 1.439
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Time to Sustained Alleviation of All Targeted COVID-19 Signs and Symptoms Through Day 28- mITT1 Population
Hide Description Sustained alleviation of all targeted COVID-19 signs/symptoms was defined as the event occurring on the first 4 consecutive days when all symptoms scored as moderate or severe at the time of enrollment were scored as mild or absent and those scored mild or absent at the time of enrollment were scored as absent. The first day of the 4 consecutive-day period was considered date of first event. Time to sustained alleviation (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained alleviation (censored), time was calculated as censoring date (last date on which symptom alleviation was assessed) minus first dose date plus 1 or Day 25 whichever occurred first.
Time Frame From Day 1 (baseline) to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
mITT1 population included all participants who were randomized and took at least one dose of study intervention and who at baseline did not receive nor were expected to receive COVID-19 therapeutic mAb treatment. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Arm/Group Title PF-07321332 300 mg + Ritonavir 100 mg Placebo
Hide Arm/Group Description:
Participants with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection received 300 milligrams (mg) PF-07321332 coadministered with 100 mg ritonavir orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.
Participants with SARS-CoV-2 infection received placebo orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.
Overall Number of Participants Analyzed 1026 1037
Median (95% Confidence Interval)
Unit of Measure: Days
13.00
(12.00 to 13.00)
15.00
(14.00 to 16.00)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PF-07321332 300 mg + Ritonavir 100 mg, Placebo
Comments Analysis of treatment effect on time to sustained alleviation is based on Cox PH model with treatment and geographic region effects as independent variables, and symptom onset duration (<=3, >3), baseline SARS-CoV-2 serology status and baseline viral load (<4 log10 copies/mL, >=4 log10 copies/mL) as covariates.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cox Proportional Hazard Model
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.270
Confidence Interval (2-Sided) 95%
1.143 to 1.411
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Time to Sustained Alleviation of All Targeted COVID-19 Signs and Symptoms Through Day 28- Modified Intent-to-Treat 2 (mITT2) Population
Hide Description Sustained alleviation of all targeted COVID-19 signs/symptoms was defined as the event occurring on the first 4 consecutive days when all symptoms scored as moderate or severe at the time of enrollment were scored as mild or absent and those scored mild or absent at the time of enrollment were scored as absent. The first day of the 4 consecutive-day period was considered date of first event. Time to sustained alleviation (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained alleviation (censored), time was calculated as censoring date (last date on which symptom alleviation was assessed) minus first dose date plus 1 or Day 25 whichever occurred first.
Time Frame From Day 1 (baseline) to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
mITT2 population included all participants who were randomized and took at least one dose of study intervention. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Arm/Group Title PF-07321332 300 mg + Ritonavir 100 mg Placebo
Hide Arm/Group Description:
Participants with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection received 300 milligrams (mg) PF-07321332 coadministered with 100 mg ritonavir orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.
Participants with SARS-CoV-2 infection received placebo orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.
Overall Number of Participants Analyzed 1093 1105
Median (95% Confidence Interval)
Unit of Measure: Days
13.00
(12.00 to 13.00)
15.00
(14.00 to 16.00)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PF-07321332 300 mg + Ritonavir 100 mg, Placebo
Comments Analysis of treatment effect on time to sustained alleviation is based on Cox PH model with treatment and geographic region effects as independent variables, and symptom onset duration (<=3, >3), COVID-19 mAb treatment (Yes/No), baseline SARS-CoV-2 serology status and baseline viral load (<4 log10 copies/mL, >=4 log10 copies/mL) as covariates.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cox Proportional Hazard Model
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.264
Confidence Interval (2-Sided) 95%
1.141 to 1.400
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Percentage of Participants With Severe Covid-19 Signs and Symptoms Through Day 28- mITT Population
Hide Description Participants were required to record the severity of their Covid-19 symptoms over the past 24 hours daily on a 4-point scale ranging from 0 to 3, higher scores indicated more severity. The scale was reported as 0= no symptoms, 1=mild, 2=moderate and 3=severe. A participant with severe score for any targeted symptoms post-baseline was counted as severe. Percentage of participants with severe Covid-19 signs and symptoms were reported.
Time Frame From Day 1 to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population included all participants who were randomized and took at least one dose of study intervention, who at baseline did not receive nor were expected to receive COVID-19 therapeutic mAb treatment and were treated <=3 days of COVID-19 onset. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Arm/Group Title PF-07321332 300 mg + Ritonavir 100 mg Placebo
Hide Arm/Group Description:
Participants with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection received 300 milligrams (mg) PF-07321332 coadministered with 100 mg ritonavir orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.
Participants with SARS-CoV-2 infection received placebo orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.
Overall Number of Participants Analyzed 686 674
Measure Type: Number
Unit of Measure: Percentage of participants
17.930 20.326
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PF-07321332 300 mg + Ritonavir 100 mg, Placebo
Comments Odds ratio, 95% CI and p-value were computed from a logistic regression model including main effects of treatment, geographic region, baseline SARS-CoV-2 serology status and baseline viral load (< 4 log10 copies/mL, >= 4 log10 copies/mL).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3872
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.882
Confidence Interval (2-Sided) 95%
0.662 to 1.173
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Percentage of Participants With Severe Covid-19 Signs and Symptoms Through Day 28- mITT1 Population
Hide Description Participants were required to record the severity of their Covid-19 symptoms over the past 24 hours daily on a 4-point scale ranging from 0 to 3, higher scores indicated more severity. The scale was reported as 0= no symptoms, 1=mild, 2=moderate and 3=severe. A participant with severe score for any targeted symptoms post-baseline was counted as severe. Percentage of participants with severe Covid-19 signs and symptoms were reported.
Time Frame From Day 1 to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
mITT1 population included all participants who were randomized and took at least one dose of study intervention and who at baseline did not receive nor were expected to receive COVID-19 therapeutic mAb treatment. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Arm/Group Title PF-07321332 300 mg + Ritonavir 100 mg Placebo
Hide Arm/Group Description:
Participants with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection received 300 milligrams (mg) PF-07321332 coadministered with 100 mg ritonavir orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.
Participants with SARS-CoV-2 infection received placebo orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.
Overall Number of Participants Analyzed 1026 1037
Measure Type: Number
Unit of Measure: Percentage of participants
19.006 20.829
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PF-07321332 300 mg + Ritonavir 100 mg, Placebo
Comments Odds ratio, 95% CI and p-value were computed from a logistic regression model including main effects of treatment, geographic region, symptom onset duration (<=3, >3), baseline SARS-CoV-2 serology status and baseline viral load (< 4 log10 copies/mL, >= 4 log10 copies/mL).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4535
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.916
Confidence Interval (2-Sided) 95%
0.728 to 1.152
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Percentage of Participants With Severe Covid-19 Signs and Symptoms Through Day 28- mITT2 Population
Hide Description Participants were required to record the severity of their Covid-19 symptoms over the past 24 hours daily on a 4-point scale ranging from 0 to 3, higher scores indicated more severity. The scale was reported as 0= no symptoms, 1=mild, 2=moderate and 3=severe. A participant with severe score for any targeted symptoms post-baseline was counted as severe. Percentage of participants with severe Covid-19 signs and symptoms were reported.
Time Frame From Day 1 to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
mITT2 population included all participants who were randomized and took at least one dose of study intervention. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Arm/Group Title PF-07321332 300 mg + Ritonavir 100 mg Placebo
Hide Arm/Group Description:
Participants with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection received 300 milligrams (mg) PF-07321332 coadministered with 100 mg ritonavir orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.
Participants with SARS-CoV-2 infection received placebo orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.
Overall Number of Participants Analyzed 1093 1105
Measure Type: Number
Unit of Measure: Percentage of participants
19.854 21.267
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PF-07321332 300 mg + Ritonavir 100 mg, Placebo
Comments Odds ratio, 95% CI and p-value were computed from a logistic regression model including main effects of treatment, geographic region, symptom onset duration (<=3, >3), COVID-19 mAb treatment (Yes/No),baseline SARS-CoV-2 serology status and baseline viral load (< 4 log10 copies/mL, >= 4 log10 copies/mL).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6103
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.944
Confidence Interval (2-Sided) 95%
0.757 to 1.178
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Time to Sustained Resolution of All Targeted COVID-19 Signs and Symptoms Through Day 28- mITT Population
Hide Description Sustained resolution was defined as when all targeted symptoms were scored as absent for 4 consecutive days. Time to sustained resolution (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained resolution (censored), time was calculated as censoring date (last date on which symptom resolution was assessed) minus first dose date plus 1 or Day 25 whichever occurred first.
Time Frame From Day 1 (baseline) to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population included all participants who were randomized and took at least one dose of study intervention, who at baseline did not receive nor were expected to receive COVID-19 therapeutic mAb treatment and were treated <=3 days of COVID-19 onset. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Arm/Group Title PF-07321332 300 mg + Ritonavir 100 mg Placebo
Hide Arm/Group Description:
Participants with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection received 300 milligrams (mg) PF-07321332 coadministered with 100 mg ritonavir orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.
Participants with SARS-CoV-2 infection received placebo orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.
Overall Number of Participants Analyzed 686 674
Median (95% Confidence Interval)
Unit of Measure: Days
16.00
(15.00 to 17.00)
18.00
(17.00 to 20.00)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PF-07321332 300 mg + Ritonavir 100 mg, Placebo
Comments Analysis of treatment effect on time to sustained resolution is based on Cox PH model with treatment and geographic region effects as independent variables, and baseline SARS-CoV-2 serology status and baseline viral load (<4 log10 copies/mL, >=4 log10 copies/mL) as covariates.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0088
Comments [Not Specified]
Method Cox Proportional Hazard Model
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.198
Confidence Interval (2-Sided) 95%
1.047 to 1.371
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Time to Sustained Resolution of All Targeted COVID-19 Signs and Symptoms Through Day 28- mITT1 Population
Hide Description Sustained resolution was defined as when all targeted symptoms were scored as absent for 4 consecutive days. Time to sustained resolution (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained resolution (censored), time was calculated as censoring date (last date on which symptom resolution was assessed) minus first dose date plus 1 or Day 25 whichever occurred first.
Time Frame From Day 1 (baseline) to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
mITT1 population included all participants who were randomized and took at least one dose of study intervention and who at baseline did not receive nor were expected to receive COVID-19 therapeutic mAb treatment. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Arm/Group Title PF-07321332 300 mg + Ritonavir 100 mg Placebo
Hide Arm/Group Description:
Participants with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection received 300 milligrams (mg) PF-07321332 coadministered with 100 mg ritonavir orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.
Participants with SARS-CoV-2 infection received placebo orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.
Overall Number of Participants Analyzed 1026 1037
Median (95% Confidence Interval)
Unit of Measure: Days
16.00
(15.00 to 17.00)
19.00
(17.00 to 20.00)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PF-07321332 300 mg + Ritonavir 100 mg, Placebo
Comments Analysis of treatment effect on time to sustained resolution is based on Cox PH model with treatment and geographic region effects as independent variables, and symptom onset duration (<=3, >3), baseline SARS-CoV-2 serology status and baseline viral load (<4 log10 copies/mL, >=4 log10 copies/mL) as covariates.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0008
Comments [Not Specified]
Method Cox Proportional Hazard Model
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.210
Confidence Interval (2-Sided) 95%
1.082 to 1.353
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Time to Sustained Resolution of All Targeted COVID-19 Signs and Symptoms Through Day 28- mITT2 Population
Hide Description Sustained resolution was defined as when all targeted symptoms were scored as absent for 4 consecutive days. Time to sustained resolution (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained resolution (censored), time was calculated as censoring date (last date on which symptom resolution was assessed) minus first dose date plus 1 or Day 25 whichever occurred first.
Time Frame From Day 1 (baseline) to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
mITT2 population included all participants who were randomized and took at least one dose of study intervention. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Arm/Group Title PF-07321332 300 mg + Ritonavir 100 mg Placebo
Hide Arm/Group Description:
Participants with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection received 300 milligrams (mg) PF-07321332 coadministered with 100 mg ritonavir orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.
Participants with SARS-CoV-2 infection received placebo orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.
Overall Number of Participants Analyzed 1093 1105
Median (95% Confidence Interval)
Unit of Measure: Days
16.00
(15.00 to 17.00)
19.00
(17.00 to 20.00)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PF-07321332 300 mg + Ritonavir 100 mg, Placebo
Comments Analysis of treatment effect on time to sustained resolution is based on Cox PH model with treatment and geographic region effects as independent variables, and symptom onset duration (<=3, >3), COVID-19 mAb treatment (Yes/No), baseline SARS-CoV-2 serology status and baseline viral load (<4 log10 copies/mL, >=4 log10 copies/mL) as covariates.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0007
Comments [Not Specified]
Method Cox Proportional Hazard Model
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.206
Confidence Interval (2-Sided) 95%
1.082 to 1.344
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT Population
Hide Description Sustained alleviation of each targeted COVID-19 signs/symptoms was defined as the event occurring on the first 4 consecutive days when each symptom scored as moderate or severe at the time of enrollment were scored as mild or absent and those scored mild or absent at the time of enrollment were scored as absent. The first day of the 4 consecutive-day period was considered date of first event. Time to sustained alleviation (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained alleviation (censored), time was calculated as censoring date (last date on which symptom alleviation was assessed) minus first dose date plus 1 or Day 25 whichever occurred first.
Time Frame From Day 1 (baseline) to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population included all participants who were randomized and took at least one dose of study intervention, who at baseline did not receive nor were expected to receive COVID-19 therapeutic mAb treatment and were treated <=3 days of COVID-19 onset. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Here, "Number Analyzed" signifies participants evaluable for each specified category.
Arm/Group Title PF-07321332 300 mg + Ritonavir 100 mg Placebo
Hide Arm/Group Description:
Participants with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection received 300 milligrams (mg) PF-07321332 coadministered with 100 mg ritonavir orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.
Participants with SARS-CoV-2 infection received placebo orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.
Overall Number of Participants Analyzed 556 548
Median (95% Confidence Interval)
Unit of Measure: Days
Muscle or body aches Number Analyzed 548 participants 532 participants
6.00
(5.00 to 7.00)
7.00
(6.00 to 8.00)
Shortness of breath or difficulty breathing Number Analyzed 287 participants 298 participants
6.00
(5.00 to 7.00)
7.00
(6.00 to 9.00)
Chills or shivering Number Analyzed 428 participants 400 participants
3.00
(3.00 to 4.00)
4.00
(4.00 to 5.00)
Cough Number Analyzed 556 participants 548 participants
8.00
(8.00 to 9.00)
10.00
(8.00 to 10.00)
Diarrhea Number Analyzed 170 participants 148 participants
4.00
(3.00 to 6.00)
4.00
(3.00 to 6.00)
Feeling hot or feverish Number Analyzed 432 participants 416 participants
3.00 [1] 
(NA to NA)
4.00
(4.00 to 5.00)
Headache Number Analyzed 511 participants 476 participants
5.00
(4.00 to 6.00)
7.00
(6.00 to 8.00)
Nausea Number Analyzed 230 participants 226 participants
4.00
(3.00 to 5.00)
5.00
(4.00 to 6.00)
Stuffy or runny nose Number Analyzed 477 participants 452 participants
6.00
(5.00 to 7.00)
7.00
(6.00 to 8.00)
Sore throat Number Analyzed 383 participants 358 participants
5.00
(4.00 to 5.00)
5.00
(5.00 to 7.00)
Vomit Number Analyzed 73 participants 71 participants
3.00
(2.00 to 4.00)
3.00
(2.00 to 5.00)
[1]
Due to variability of data, the number of participants with events available was not sufficient for the calculation of the limits using KM.
15.Secondary Outcome
Title Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population
Hide Description Sustained alleviation of each targeted COVID-19 signs/symptoms was defined as the event occurring on the first 4 consecutive days when each symptom scored as moderate or severe at the time of enrollment were scored as mild or absent and those scored mild or absent at the time of enrollment were scored as absent. The first day of the 4 consecutive-day period was considered date of first event. Time to sustained alleviation (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained alleviation (censored), time was calculated as censoring date (last date on which symptom alleviation was assessed) minus first dose date plus 1 or Day 25 whichever occurred first.
Time Frame From Day 1 (baseline) to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
mITT1 population included all participants who were randomized and took at least one dose of study intervention and who at baseline did not receive nor were expected to receive COVID-19 therapeutic mAb treatment. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Here, "Number Analyzed" signifies participants evaluable for each specified category.
Arm/Group Title PF-07321332 300 mg + Ritonavir 100 mg Placebo
Hide Arm/Group Description:
Participants with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection received 300 milligrams (mg) PF-07321332 coadministered with 100 mg ritonavir orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.
Participants with SARS-CoV-2 infection received placebo orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.
Overall Number of Participants Analyzed 837 856
Median (95% Confidence Interval)
Unit of Measure: Days
Muscle or body aches Number Analyzed 825 participants 823 participants
6.00
(5.00 to 6.00)
7.00
(7.00 to 8.00)
Shortness of breath or difficulty breathing Number Analyzed 454 participants 469 participants
6.00
(5.00 to 7.00)
8.00
(7.00 to 9.00)
Chills or shivering Number Analyzed 616 participants 612 participants
3.00
(3.00 to 4.00)
4.00
(4.00 to 5.00)
Cough Number Analyzed 837 participants 856 participants
8.00
(8.00 to 9.00)
10.00
(9.00 to 10.00)
Diarrhea Number Analyzed 278 participants 259 participants
5.00
(4.00 to 6.00)
4.00
(3.00 to 5.00)
Feeling hot or feverish Number Analyzed 631 participants 640 participants
3.00
(3.00 to 4.00)
5.00
(4.00 to 5.00)
Headache Number Analyzed 755 participants 751 participants
5.00
(5.00 to 6.00)
7.00
(7.00 to 8.00)
Nausea Number Analyzed 370 participants 374 participants
5.00
(4.00 to 6.00)
6.00
(5.00 to 7.00)
Stuffy or runny nose Number Analyzed 719 participants 704 participants
6.00
(5.00 to 6.00)
7.00
(7.00 to 8.00)
Sore throat Number Analyzed 573 participants 579 participants
5.00
(4.00 to 5.00)
6.00
(5.00 to 7.00)
Vomit Number Analyzed 124 participants 117 participants
3.00
(2.00 to 3.00)
3.00
(2.00 to 5.00)
16.Secondary Outcome
Title Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population
Hide Description Sustained alleviation of each targeted COVID-19 signs/symptoms was defined as the event occurring on the first 4 consecutive days when each symptom scored as moderate or severe at the time of enrollment were scored as mild or absent and those scored mild or absent at the time of enrollment were scored as absent. The first day of the 4 consecutive-day period was considered date of first event. Time to sustained alleviation (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained alleviation (censored), time was calculated as censoring date (last date on which symptom alleviation was assessed) minus first dose date plus 1 or Day 25 whichever occurred first.
Time Frame From Day 1 (baseline) to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
mITT2 population included all participants who were randomized and took at least one dose of study intervention. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Here, "Number Analyzed" signifies participants evaluable for each specified category.
Arm/Group Title PF-07321332 300 mg + Ritonavir 100 mg Placebo
Hide Arm/Group Description:
Participants with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection received 300 milligrams (mg) PF-07321332 coadministered with 100 mg ritonavir orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.
Participants with SARS-CoV-2 infection received placebo orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.
Overall Number of Participants Analyzed 892 917
Median (95% Confidence Interval)
Unit of Measure: Days
Muscle or body aches Number Analyzed 880 participants 879 participants
6.000
(5.000 to 7.000)
8.000
(7.000 to 8.000)
Shortness of breath or difficulty breathing Number Analyzed 492 participants 507 participants
6.000
(5.000 to 7.000)
8.000
(7.000 to 10.000)
Chills or shivering Number Analyzed 664 participants 657 participants
3.000
(3.000 to 4.000)
4.000
(4.000 to 5.000)
Cough Number Analyzed 892 participants 917 participants
8.000
(8.000 to 9.000)
10.000
(9.000 to 10.000)
Diarrhea Number Analyzed 305 participants 290 participants
5.000
(4.000 to 6.000)
4.000
(3.000 to 5.000)
Feeling hot or feverish Number Analyzed 683 participants 686 participants
3.000
(3.000 to 4.000)
4.000
(4.000 to 5.000)
Headache Number Analyzed 809 participants 806 participants
5.000
(5.000 to 6.000)
7.000
(7.000 to 8.000)
Nausea Number Analyzed 397 participants 402 participants
5.000
(4.000 to 6.000)
6.000
(5.000 to 7.000)
Stuffy or runny nose Number Analyzed 773 participants 762 participants
6.000
(5.000 to 6.000)
7.000
(7.000 to 8.000)
Sore throat Number Analyzed 610 participants 627 participants
5.000
(4.000 to 5.000)
6.000
(5.000 to 7.000)
Vomit Number Analyzed 141 participants 138 participants
3.000
(2.000 to 4.000)
3.000
(2.000 to 5.000)
17.Secondary Outcome
Title Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT Population
Hide Description Sustained resolution was defined as when each targeted symptom was scored as absent for 4 consecutive days. Time to sustained resolution (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained resolution (censored), time was calculated as censoring date (last date on which symptom resolution was assessed) minus first dose date plus 1 or Day 25 whichever occurred first.
Time Frame From Day 1 (baseline) to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population included all participants who were randomized and took at least one dose of study intervention, who at baseline did not receive nor were expected to receive COVID-19 therapeutic mAb treatment and were treated <=3 days of COVID-19 onset. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Here, "Number Analyzed" signifies participants evaluable for each specified category.
Arm/Group Title PF-07321332 300 mg + Ritonavir 100 mg Placebo
Hide Arm/Group Description:
Participants with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection received 300 milligrams (mg) PF-07321332 coadministered with 100 mg ritonavir orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.
Participants with SARS-CoV-2 infection received placebo orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.
Overall Number of Participants Analyzed 556 548
Median (95% Confidence Interval)
Unit of Measure: Days
Muscle or body aches Number Analyzed 548 participants 532 participants
9.000
(8.000 to 11.000)
12.000
(11.000 to 13.000)
Shortness of breath or difficulty breathing Number Analyzed 287 participants 298 participants
8.000
(7.000 to 9.000)
11.000
(10.000 to 14.000)
Chills or shivering Number Analyzed 428 participants 400 participants
5.000
(4.000 to 5.000)
6.000
(5.000 to 7.000)
Cough Number Analyzed 556 participants 548 participants
13.000
(12.000 to 13.000)
14.000
(13.000 to 16.000)
Diarrhea Number Analyzed 170 participants 148 participants
6.000
(5.000 to 8.000)
6.000
(4.000 to 9.000)
Feeling hot or feverish Number Analyzed 432 participants 416 participants
5.000
(4.000 to 5.000)
7.000
(6.000 to 7.000)
Headache Number Analyzed 511 participants 476 participants
8.000
(8.000 to 9.000)
11.000
(9.000 to 13.000)
Nausea Number Analyzed 230 participants 226 participants
5.000
(4.000 to 7.000)
7.000
(6.000 to 10.000)
Stuffy or runny nose Number Analyzed 477 participants 452 participants
9.000
(9.000 to 10.000)
10.000
(9.000 to 11.000)
Sore throat Number Analyzed 383 participants 358 participants
7.000
(6.000 to 7.000)
9.000
(8.000 to 10.000)
Vomit Number Analyzed 73 participants 71 participants
3.000
(2.000 to 5.000)
3.000
(2.000 to 5.000)
18.Secondary Outcome
Title Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population
Hide Description Sustained resolution was defined as when each targeted symptom was scored as absent for 4 consecutive days. Time to sustained resolution (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained resolution (censored), time was calculated as censoring date (last date on which symptom resolution was assessed) minus first dose date plus 1 or Day 25 whichever occurred first.
Time Frame From Day 1 (baseline) to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
mITT1 population included all participants who were randomized and took at least one dose of study intervention and who at baseline did not receive nor were expected to receive COVID-19 therapeutic mAb treatment. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Here, "Number Analyzed" signifies participants evaluable for each specified category.
Arm/Group Title PF-07321332 300 mg + Ritonavir 100 mg Placebo
Hide Arm/Group Description:
Participants with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection received 300 milligrams (mg) PF-07321332 coadministered with 100 mg ritonavir orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.
Participants with SARS-CoV-2 infection received placebo orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.
Overall Number of Participants Analyzed 837 856
Median (95% Confidence Interval)
Unit of Measure: Days
Muscle or body aches Number Analyzed 825 participants 823 participants
9.000
(8.000 to 10.000)
12.000
(11.000 to 13.000)
Shortness of breath or difficulty breathing Number Analyzed 454 participants 469 participants
8.000
(7.000 to 9.000)
12.000
(10.000 to 14.000)
Chills or shivering Number Analyzed 616 participants 612 participants
5.000
(4.000 to 5.000)
7.000
(6.000 to 7.000)
Cough Number Analyzed 837 participants 856 participants
13.000
(12.000 to 13.000)
15.000
(14.000 to 16.000)
Diarrhea Number Analyzed 278 participants 259 participants
6.000
(6.000 to 7.000)
6.000
(5.000 to 8.000)
Feeling hot or feverish Number Analyzed 631 participants 640 participants
5.000 [1] 
(NA to NA)
7.000
(6.000 to 8.000)
Headache Number Analyzed 755 participants 751 participants
9.000
(8.000 to 10.000)
11.000
(10.000 to 13.000)
Nausea Number Analyzed 370 participants 374 participants
7.000
(6.000 to 8.000)
7.000
(6.000 to 9.000)
Stuffy or runny nose Number Analyzed 719 participants 704 participants
9.000
(9.000 to 10.000)
10.000
(9.000 to 11.000)
Sore throat Number Analyzed 573 participants 579 participants
7.000
(6.000 to 8.000)
9.000
(8.000 to 10.000)
Vomit Number Analyzed 124 participants 117 participants
3.000
(2.000 to 4.000)
3.000
(2.000 to 5.000)
[1]
Due to variability of data, the number of participants with events available was not sufficient for the calculation of the limits using KM.
19.Secondary Outcome
Title Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population
Hide Description Sustained resolution was defined as when each targeted symptom was scored as absent for 4 consecutive days. Time to sustained resolution (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained resolution (censored), time was calculated as censoring date (last date on which symptom resolution was assessed) minus first dose date plus 1 or Day 25 whichever occurred first.
Time Frame From Day 1 (baseline) to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
mITT2 population included all participants who were randomized and took at least one dose of study intervention. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Here, "Number Analyzed" signifies participants evaluable for each specified category.
Arm/Group Title PF-07321332 300 mg + Ritonavir 100 mg Placebo
Hide Arm/Group Description:
Participants with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection received 300 milligrams (mg) PF-07321332 coadministered with 100 mg ritonavir orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.
Participants with SARS-CoV-2 infection received placebo orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.
Overall Number of Participants Analyzed 892 917
Median (95% Confidence Interval)
Unit of Measure: Days
Muscle or body aches Number Analyzed 880 participants 879 participants
9.000
(8.000 to 10.000)
12.000
(11.000 to 13.000)
Shortness of breath or difficulty breathing Number Analyzed 492 participants 507 participants
9.000
(7.000 to 10.000)
13.000
(11.000 to 15.000)
Chills or shivering Number Analyzed 664 participants 657 participants
5.000
(4.000 to 5.000)
6.000
(6.000 to 7.000)
Cough Number Analyzed 892 participants 917 participants
13.000
(12.000 to 13.000)
15.000
(14.000 to 16.000)
Diarrhea Number Analyzed 305 participants 290 participants
6.000
(6.000 to 7.000)
6.000
(5.000 to 8.000)
Feeling hot or feverish Number Analyzed 683 participants 686 participants
5.000 [1] 
(NA to NA)
7.000
(6.000 to 7.000)
Headache Number Analyzed 809 participants 806 participants
9.000
(8.000 to 10.000)
11.000
(10.000 to 12.000)
Nausea Number Analyzed 397 participants 402 participants
7.000
(6.000 to 8.000)
7.000
(6.000 to 9.000)
Stuffy or runny nose Number Analyzed 773 participants 762 participants
9.000
(9.000 to 10.000)
11.000
(10.000 to 12.000)
Sore throat Number Analyzed 610 participants 627 participants
7.000
(6.000 to 8.000)
9.000
(8.000 to 10.000)
Vomit Number Analyzed 141 participants 138 participants
3.000
(3.000 to 5.000)
4.000
(2.000 to 5.000)
[1]
Due to variability of data, the number of participants with events available was not sufficient for the calculation of the limits using KM.
20.Secondary Outcome
Title Number of Participants With Progression to a Worsening Status in 1 or More Self-reported COVID-19 Associated Symptoms Through Day 28-mITT Population
Hide Description Participants were required to record the severity of their Covid-19 symptoms over the past 24 hours daily on a 4-point scale where 0 = no symptoms; 1= mild; 2= moderate; and 3= severe. Vomiting and diarrhea were each rated on a 4-point frequency scale where 0= no occurrence, 1= mild for 1 to 2 times, 2= moderate for 3 to 4 times, and 3= severe for 5 or greater. Progression to a worsening status for any targeted symptom was based up on increasing severity (i.e. the first time any targeted symptoms worsened after treatment relative to baseline).
Time Frame From Day 1 (baseline) to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population included all participants who were randomized and took at least one dose of study intervention, who at baseline did not receive nor were expected to receive COVID-19 therapeutic mAb treatment and were treated <=3 days of COVID-19 onset. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
Arm/Group Title PF-07321332 300 mg + Ritonavir 100 mg Placebo
Hide Arm/Group Description:
Participants with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection received 300 milligrams (mg) PF-07321332 coadministered with 100 mg ritonavir orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.
Participants with SARS-CoV-2 infection received placebo orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.
Overall Number of Participants Analyzed 686 674
Measure Type: Count of Participants
Unit of Measure: Participants
523
  76.2%
504
  74.8%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PF-07321332 300 mg + Ritonavir 100 mg, Placebo
Comments Odds ratio, 95% CI and p-value were computed from a logistic regression model including main effects of treatment, geographic region, baseline SARS-CoV-2 serology status and baseline viral load (< 4 log10 copies/mL, >= 4 log10 copies/mL).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4374
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.108
Confidence Interval (2-Sided) 95%
0.855 to 1.435
Estimation Comments [Not Specified]
21.Secondary Outcome
Title Number of Participants With Progression to a Worsening Status in 1 or More Self-reported COVID-19 Associated Symptoms Through Day 28-mITT1 Population
Hide Description Participants were required to record the severity of their Covid-19 symptoms over the past 24 hours daily on a 4-point scale where 0 = no symptoms; 1= mild; 2= moderate; and 3= severe. Vomiting and diarrhea were each rated on a 4-point frequency scale where 0= no occurrence, 1= mild for 1 to 2 times, 2= moderate for 3 to 4 times, and 3= severe for 5 or greater. Progression to a worsening status for any targeted symptom was based up on increasing severity (i.e. the first time any targeted symptoms worsened after treatment relative to baseline).
Time Frame From Day 1 (baseline) to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
mITT1 population included all participants who were randomized and took at least one dose of study intervention and who at baseline did not receive nor were expected to receive COVID-19 therapeutic mAb treatment. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
Arm/Group Title PF-07321332 300 mg + Ritonavir 100 mg Placebo
Hide Arm/Group Description:
Participants with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection received 300 milligrams (mg) PF-07321332 coadministered with 100 mg ritonavir orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.
Participants with SARS-CoV-2 infection received placebo orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.
Overall Number of Participants Analyzed 1026 1037
Measure Type: Count of Participants
Unit of Measure: Participants
763
  74.4%
768
  74.1%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PF-07321332 300 mg + Ritonavir 100 mg, Placebo
Comments Odds ratio, 95% CI and p-value were computed from a logistic regression model including main effects of treatment, geographic region, symptom onset duration (<=3, >3), baseline SARS-CoV-2 serology status and baseline viral load (< 4 log10 copies/mL, >= 4 log10 copies/mL).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9235
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.010
Confidence Interval (2-Sided) 95%
0.823 to 1.240
Estimation Comments [Not Specified]
22.Secondary Outcome
Title Number of Participants With Progression to a Worsening Status in 1 or More Self-reported COVID-19 Associated Symptoms Through Day 28-mITT2 Population
Hide Description Participants were required to record the severity of their Covid-19 symptoms over the past 24 hours daily on a 4-point scale where 0 = no symptoms; 1= mild; 2= moderate; and 3= severe. Vomiting and diarrhea were each rated on a 4-point frequency scale where 0= no occurrence, 1= mild for 1 to 2 times, 2= moderate for 3 to 4 times, and 3= severe for 5 or greater. Progression to a worsening status for any targeted symptom was based up on increasing severity (i.e. the first time any targeted symptoms worsened after treatment relative to baseline).
Time Frame From Day 1 (baseline) to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
mITT2 population included all participants who were randomized and took at least one dose of study intervention. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
Arm/Group Title PF-07321332 300 mg + Ritonavir 100 mg Placebo
Hide Arm/Group Description:
Participants with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection received 300 milligrams (mg) PF-07321332 coadministered with 100 mg ritonavir orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.
Participants with SARS-CoV-2 infection received placebo orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.
Overall Number of Participants Analyzed 1093 1105
Measure Type: Count of Participants
Unit of Measure: Participants
819
  74.9%
822
  74.4%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PF-07321332 300 mg + Ritonavir 100 mg, Placebo
Comments Odds ratio, 95% CI and p-value were computed from a logistic regression model including main effects of treatment, geographic region, symptom onset duration (<=3, >3), COVID-19 mAb treatment (Yes/No), baseline SARS-CoV-2 serology status and baseline viral load (< 4 log10 copies/mL, >= 4 log10 copies/mL).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9074
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.012
Confidence Interval (2-Sided) 95%
0.828 to 1.236
Estimation Comments [Not Specified]
23.Secondary Outcome
Title Percentage of Participants With a Resting Peripheral Oxygen Saturation >=95% at Days 1 and 5- mITT Population
Hide Description In this outcome measure, the percentage of participants with a resting peripheral oxygen saturation >=95% were reported.
Time Frame Day 1, 5
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population included all participants who were randomized and took at least one dose of study intervention, who at baseline did not receive nor were expected to receive COVID-19 therapeutic mAb treatment and were treated <=3 days of COVID-19 onset.
Arm/Group Title PF-07321332 300 mg + Ritonavir 100 mg Placebo
Hide Arm/Group Description:
Participants with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection received 300 milligrams (mg) PF-07321332 coadministered with 100 mg ritonavir orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.
Participants with SARS-CoV-2 infection received placebo orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.
Overall Number of Participants Analyzed 697 682
Measure Type: Number
Unit of Measure: Percentage of participants
Day 1 Number Analyzed 697 participants 682 participants
93.54 92.37
Day 5 Number Analyzed 652 participants 630 participants
93.09 89.68
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PF-07321332 300 mg + Ritonavir 100 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2331
Comments [Not Specified]
Method Breslow-Day test
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 19.581
Confidence Interval 95%
7.879 to 48.661
Estimation Comments Odds ratio for Day 5 vs Day 1: PF-07321332 300 mg + Ritonavir 100 mg
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PF-07321332 300 mg + Ritonavir 100 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2331
Comments [Not Specified]
Method Breslow-Day test
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 9.539
Confidence Interval (2-Sided) 95%
4.435 to 20.518
Estimation Comments Odds ratio for Day 5 vs Day 1: Placebo
24.Secondary Outcome
Title Percentage of Participants With a Resting Peripheral Oxygen Saturation >=95% at Days 1 and 5- mITT1 Population
Hide Description In this outcome measure, the percentage of participants with a resting peripheral oxygen saturation >=95% were reported.
Time Frame Day 1, 5
Hide Outcome Measure Data
Hide Analysis Population Description
mITT1 population included all participants who were randomized and took at least one dose of study intervention and who at baseline did not receive nor were expected to receive COVID-19 therapeutic mAb treatment. Here, "Number Analyzed" signifies participants evaluable for each specified time point.
Arm/Group Title PF-07321332 300 mg + Ritonavir 100 mg Placebo
Hide Arm/Group Description:
Participants with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection received 300 milligrams (mg) PF-07321332 coadministered with 100 mg ritonavir orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.
Participants with SARS-CoV-2 infection received placebo orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.
Overall Number of Participants Analyzed 1039 1046
Measure Type: Number
Unit of Measure: Percentage of participants
Day 1 Number Analyzed 1039 participants 1046 participants
93.64 92.63
Day 5 Number Analyzed 973 participants 969 participants
91.77 88.13
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PF-07321332 300 mg + Ritonavir 100 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3034
Comments [Not Specified]
Method Breslow-Day test
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 21.780
Confidence Interval (2-Sided) 95%
10.555 to 44.946
Estimation Comments Odds ratio for Day 5 vs Day 1: PF-07321332 300 mg + Ritonavir 100 mg
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PF-07321332 300 mg + Ritonavir 100 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3034
Comments [Not Specified]
Method Breslow Day test
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 13.309
Confidence Interval (2-Sided) 95%
7.294 to 24.283
Estimation Comments Odds ratio for Day 5 vs Day 1: Placebo
25.Secondary Outcome
Title Percentage of Participants With a Resting Peripheral Oxygen Saturation >=95% at Days 1 and 5- mITT2 Population
Hide Description In this outcome measure, the percentage of participants with a resting peripheral oxygen saturation >=95% were reported.
Time Frame Day 1, 5
Hide Outcome Measure Data
Hide Analysis Population Description
mITT2 population included all participants who were randomized and took at least one dose of study intervention. Here, "Number Analyzed" signifies participants evaluable for each specified time point.
Arm/Group Title PF-07321332 300 mg + Ritonavir 100 mg Placebo
Hide Arm/Group Description:
Participants with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection received 300 milligrams (mg) PF-07321332 coadministered with 100 mg ritonavir orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.
Participants with SARS-CoV-2 infection received placebo orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.
Overall Number of Participants Analyzed 1109 1115
Measure Type: Number
Unit of Measure: Percentage of participants
Day 1 Number Analyzed 1109 participants 1115 participants
93.59 92.19
Day 5 Number Analyzed 1038 participants 1028 participants
91.81 88.13
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PF-07321332 300 mg + Ritonavir 100 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2342
Comments [Not Specified]
Method Breslow-Day test
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 21.659
Confidence Interval (2-Sided) 95%
10.712 to 43.794
Estimation Comments Odds ratio for Day 5 vs Day 1: PF-07321332 300 mg + Ritonavir 100 mg
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PF-07321332 300 mg + Ritonavir 100 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2342
Comments [Not Specified]
Method Breslow-Day test
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 12.545
Confidence Interval (2-Sided) 95%
7.113 to 22.123
Estimation Comments Odds ratio for Day 5 vs Day 1: Placebo
26.Secondary Outcome
Title Percentage of Participants Who Died Through Week 24- mITT Population
Hide Description In this outcome measure, percentage of participants with death due to any cause was presented.
Time Frame From Day 1 up to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population included all participants who were randomized and took at least one dose of study intervention, who at baseline did not receive nor were expected to receive COVID-19 therapeutic mAb treatment and were treated <=3 days of COVID-19 onset.
Arm/Group Title PF-07321332 300 mg + Ritonavir 100 mg Placebo
Hide Arm/Group Description:
Participants with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection received 300 milligrams (mg) PF-07321332 coadministered with 100 mg ritonavir orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.
Participants with SARS-CoV-2 infection received placebo orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.
Overall Number of Participants Analyzed 697 682
Measure Type: Number
Unit of Measure: Percentage of participants
0 1.6
27.Secondary Outcome
Title Percentage of Participants Who Died Through Week 24- mITT1 Population
Hide Description In this outcome measure, percentage of participants with death due to any cause was presented.
Time Frame From Day 1 up to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
mITT1 population included all participants who were randomized and took at least one dose of study intervention and who at baseline did not receive nor were expected to receive COVID-19 therapeutic mAb treatment.
Arm/Group Title PF-07321332 300 mg + Ritonavir 100 mg Placebo
Hide Arm/Group Description:
Participants with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection received 300 milligrams (mg) PF-07321332 coadministered with 100 mg ritonavir orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.
Participants with SARS-CoV-2 infection received placebo orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.
Overall Number of Participants Analyzed 1039 1046
Measure Type: Number
Unit of Measure: Percentage of participants
0 1.4
28.Secondary Outcome
Title Percentage of Participants Who Died Through Week 24- mITT2 Population
Hide Description In this outcome measure, percentage of participants with death due to any cause was presented.
Time Frame From Day 1 up to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
mITT2 population included all participants who were randomized and took at least one dose of study intervention.
Arm/Group Title PF-07321332 300 mg + Ritonavir 100 mg Placebo
Hide Arm/Group Description:
Participants with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection received 300 milligrams (mg) PF-07321332 coadministered with 100 mg ritonavir orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.
Participants with SARS-CoV-2 infection received placebo orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.
Overall Number of Participants Analyzed 1109 1115
Measure Type: Number
Unit of Measure: Percentage of participants
0 1.3
29.Secondary Outcome
Title Plasma Concentration Versus Time Summary of PF-07321332
Hide Description [Not Specified]
Time Frame 1 Hour post-dose on Day 1 and pre-dose on Day 5
Hide Outcome Measure Data
Hide Analysis Population Description
SAS population included all participants who were randomized and took at least one dose of study intervention. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Here "Number Analyzed" signifies participants evaluable for the specified time point.
Arm/Group Title PF-07321332 300 mg + Ritonavir 100 mg
Hide Arm/Group Description:
Participants with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection received 300 milligrams (mg) PF-07321332 coadministered with 100 mg ritonavir orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.
Overall Number of Participants Analyzed 548
Mean (Standard Deviation)
Unit of Measure: Nanograms per milliliter
Day 1 (1 Hour post dose) Number Analyzed 282 participants
2186  (2106.5)
Day 5 (Pre-dose) Number Analyzed 548 participants
2964  (2851.4)
30.Secondary Outcome
Title Change From Baseline in Logarithm to Base10 (Log10) Transformed Viral Load at Day 3, 5, 10 and 14- mITT Population
Hide Description The viral load was measured in nasal or nasopharyngeal samples using reverse transcription polymerase chain reaction (RT-PCR).
Time Frame Baseline, Day 3, 5, 10 and 14
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population included all participants who were randomized and took at least one dose of study intervention, who at baseline did not receive nor were expected to receive COVID-19 therapeutic mAb treatment and were treated <=3 days of COVID-19 onset. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Here, "Number Analyzed" signifies participants evaluable for each specified time point.
Arm/Group Title PF-07321332 300 mg + Ritonavir 100 mg Placebo
Hide Arm/Group Description:
Participants with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection received 300 milligrams (mg) PF-07321332 coadministered with 100 mg ritonavir orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.
Participants with SARS-CoV-2 infection received placebo orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.
Overall Number of Participants Analyzed 529 526
Mean (Standard Deviation)
Unit of Measure: Log10 copies per milliliter
Day 3 Number Analyzed 529 participants 526 participants
-1.821  (1.832) -1.199  (1.754)
Day 5 Number Analyzed 508 participants 507 participants
-3.202  (1.752) -2.252  (1.809)
Day 10 Number Analyzed 503 participants 476 participants
-4.532  (2.101) -3.984  (2.109)
Day 14 Number Analyzed 507 participants 501 participants
-5.098  (2.129) -4.840  (2.111)
31.Secondary Outcome
Title Change From Baseline in Log10 Transformed Viral Load at Day 3, 5, 10 and 14- mITT1 Population
Hide Description The viral load was measured in nasal or nasopharyngeal samples using RT-PCR.
Time Frame Baseline, Day 3, 5, 10 and 14
Hide Outcome Measure Data
Hide Analysis Population Description
mITT1 population included all participants who were randomized and took at least one dose of study intervention and who at baseline did not receive nor were expected to receive COVID-19 therapeutic mAb treatment. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Here, "Number Analyzed" signifies participants evaluable for each specified time point.
Arm/Group Title PF-07321332 300 mg + Ritonavir 100 mg Placebo
Hide Arm/Group Description:
Participants with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection received 300 milligrams (mg) PF-07321332 coadministered with 100 mg ritonavir orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.
Participants with SARS-CoV-2 infection received placebo orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.
Overall Number of Participants Analyzed 767 780
Mean (Standard Deviation)
Unit of Measure: Log10 copies per milliliter
Day 3 Number Analyzed 767 participants 780 participants
-1.756  (1.743) -1.191  (1.734)
Day 5 Number Analyzed 736 participants 741 participants
-2.977  (1.778) -2.166  (1.785)
Day 10 Number Analyzed 731 participants 710 participants
-4.274  (2.103) -3.773  (2.048)
Day 14 Number Analyzed 740 participants 745 participants
-4.813  (2.144) -4.521  (2.134)
32.Secondary Outcome
Title Change From Baseline in Log10 Transformed Viral Load at Day 3, 5, 10 and 14- mITT2 Population
Hide Description The viral load was measured in nasal or nasopharyngeal samples using RT-PCR.
Time Frame Baseline, Day 3, 5, 10 and 14
Hide Outcome Measure Data
Hide Analysis Population Description
mITT2 population included all participants who were randomized and took at least one dose of study intervention. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. Here, "Number Analyzed" signifies participants evaluable for each specified time point.
Arm/Group Title PF-07321332 300 mg + Ritonavir 100 mg Placebo
Hide Arm/Group Description:
Participants with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection received 300 milligrams (mg) PF-07321332 coadministered with 100 mg ritonavir orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.
Participants with SARS-CoV-2 infection received placebo orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.
Overall Number of Participants Analyzed 821 830
Mean (Standard Deviation)
Unit of Measure: Log10 copies per milliliter
Day 3 Number Analyzed 821 participants 830 participants
-1.788  (1.744) -1.187  (1.705)
Day 5 Number Analyzed 789 participants 792 participants
-2.994  (1.783) -2.184  (1.781)
Day 10 Number Analyzed 783 participants 761 participants
-4.288  (2.112) -3.778  (2.033)
Day 14 Number Analyzed 794 participants 801 participants
-4.801  (2.146) -4.506  (2.139)
33.Secondary Outcome
Title Number of COVID-19 Related Medical Visits- mITT Population
Hide Description Medical visits included emergency room, practitioner's office, home healthcare services, urgent care, telephone consultation, outpatient infusion center, other, COVID-19-related-hospitalization (intensive care unit [ICU] and non-ICU stays). In this outcome measure, COVID-19-related medical visits of participants were reported.
Time Frame From Day 1 up to Day 34
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population included all participants who were randomized and took at least one dose of study intervention, who at baseline did not receive nor were expected to receive COVID-19 therapeutic mAb treatment and were treated <=3 days of COVID-19 onset.
Arm/Group Title PF-07321332 300 mg + Ritonavir 100 mg Placebo
Hide Arm/Group Description:
Participants with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection received 300 milligrams (mg) PF-07321332 coadministered with 100 mg ritonavir orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.
Participants with SARS-CoV-2 infection received placebo orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.
Overall Number of Participants Analyzed 697 682
Measure Type: Number
Unit of Measure: Visits
22 81
34.Secondary Outcome
Title Number of COVID-19 Related Medical Visits- mITT1 Population
Hide Description Medical visits included emergency room, practitioner's office, home healthcare services, urgent care, telephone consultation, outpatient infusion center, other, COVID-19-related-hospitalization (ICU and non-ICU stays). In this outcome measure, COVID-19-related medical visits of participants were reported.
Time Frame From Day 1 up to Day 34
Hide Outcome Measure Data
Hide Analysis Population Description
mITT1 population included all participants who were randomized and took at least one dose of study intervention and who at baseline did not receive nor were expected to receive COVID-19 therapeutic mAb treatment.
Arm/Group Title PF-07321332 300 mg + Ritonavir 100 mg Placebo
Hide Arm/Group Description:
Participants with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection received 300 milligrams (mg) PF-07321332 coadministered with 100 mg ritonavir orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.
Participants with SARS-CoV-2 infection received placebo orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.
Overall Number of Participants Analyzed 1039 1046
Measure Type: Number
Unit of Measure: Visits
41 134
35.Secondary Outcome
Title Number of COVID-19 Related Medical Visits- mITT2 Population
Hide Description Medical visits included emergency room, practitioner's office, home healthcare services, urgent care, telephone consultation, outpatient infusion center, other, COVID-19-related-hospitalization (ICU and non-ICU stays). In this outcome measure, COVID-19-related medical visits of participants were reported.
Time Frame From Day 1 up to Day 34
Hide Outcome Measure Data
Hide Analysis Population Description
mITT2 population included all participants who were randomized and took at least one dose of study intervention.
Arm/Group Title PF-07321332 300 mg + Ritonavir 100 mg Placebo
Hide Arm/Group Description:
Participants with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection received 300 milligrams (mg) PF-07321332 coadministered with 100 mg ritonavir orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.
Participants with SARS-CoV-2 infection received placebo orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.
Overall Number of Participants Analyzed 1109 1115
Measure Type: Number
Unit of Measure: Visits
46 150
36.Secondary Outcome
Title Number of Days in Hospital and ICU for the Treatment of COVID-19- mITT Population
Hide Description [Not Specified]
Time Frame From Day 1 up to Day 34
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population included all participants who were randomized and took at least one dose of study intervention, who at baseline did not receive nor were expected to receive COVID-19 therapeutic mAb treatment and were treated <=3 days of COVID-19 onset. The analysis was performed on all participants (i.e. hospitalized and non-hospitalized participants were included).
Arm/Group Title PF-07321332 300 mg + Ritonavir 100 mg Placebo
Hide Arm/Group Description:
Participants with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection received 300 milligrams (mg) PF-07321332 coadministered with 100 mg ritonavir orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.
Participants with SARS-CoV-2 infection received placebo orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.
Overall Number of Participants Analyzed 697 682
Mean (Standard Deviation)
Unit of Measure: Days
Duration of hospitalization visits 0.085  (1.030) 0.801  (4.421)
Duration of ICU visits 0.000  (0.000) 0.170  (2.327)
Duration of non-ICU visits 0.085  (1.030) 0.632  (3.616)
37.Secondary Outcome
Title Number of Days in Hospital and ICU for the Treatment of COVID-19- mITT1 Population
Hide Description [Not Specified]
Time Frame From Day 1 up to Day 34
Hide Outcome Measure Data
Hide Analysis Population Description
mITT1 population included all participants who were randomized and took at least one dose of study intervention and who at baseline did not receive nor were expected to receive COVID-19 therapeutic mAb treatment. The analysis was performed on all participants (i.e. hospitalized and non-hospitalized participants were included).
Arm/Group Title PF-07321332 300 mg + Ritonavir 100 mg Placebo
Hide Arm/Group Description:
Participants with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection received 300 milligrams (mg) PF-07321332 coadministered with 100 mg ritonavir orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.
Participants with SARS-CoV-2 infection received placebo orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.
Overall Number of Participants Analyzed 1039 1046
Mean (Standard Deviation)
Unit of Measure: Days
Duration of hospitalization visits 0.082  (0.938) 0.733  (3.950)
Duration of ICU visits 0.000  (0.000) 0.121  (1.910)
Duration of non-ICU visits 0.082  (0.938) 0.613  (3.358)
38.Secondary Outcome
Title Number of Days in Hospital and ICU for the Treatment of COVID-19- mITT2 Population
Hide Description [Not Specified]
Time Frame From Day 1 up to Day 34
Hide Outcome Measure Data
Hide Analysis Population Description
mITT2 population included all participants who were randomized and took at least one dose of study intervention. The analysis was performed on all participants (i.e. hospitalized and non-hospitalized participants were included).
Arm/Group Title PF-07321332 300 mg + Ritonavir 100 mg Placebo
Hide Arm/Group Description:
Participants with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection received 300 milligrams (mg) PF-07321332 coadministered with 100 mg ritonavir orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.
Participants with SARS-CoV-2 infection received placebo orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.
Overall Number of Participants Analyzed 1109 1115
Mean (Standard Deviation)
Unit of Measure: Days
Duration of hospitalization visits 0.086  (0.956) 0.697  (3.835)
Duration of ICU visits 0.000  (0.000) 0.114  (1.850)
Duration of non-ICU visits 0.086  (0.956) 0.584  (3.262)
Time Frame From start of study intervention at Day 1 up to end of long-term safety follow-up (Week 24)
Adverse Event Reporting Description Same event may appear as both AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. SAS population included all participants who were randomized and took at least one dose of investigational product.
 
Arm/Group Title PF-07321332 300 mg + Ritonavir 100 mg Placebo
Hide Arm/Group Description Participants with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection received 300 milligrams (mg) PF-07321332 coadministered with 100 mg ritonavir orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24. Participants with SARS-CoV-2 infection received placebo orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.
All-Cause Mortality
PF-07321332 300 mg + Ritonavir 100 mg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1109 (0.00%)   15/1115 (1.35%) 
Hide Serious Adverse Events
PF-07321332 300 mg + Ritonavir 100 mg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   20/1109 (1.80%)   75/1115 (6.73%) 
Blood and lymphatic system disorders     
Anaemia * 1  0/1109 (0.00%)  1/1115 (0.09%) 
Cardiac disorders     
Palpitations * 1  1/1109 (0.09%)  0/1115 (0.00%) 
Gastrointestinal disorders     
Rectal haemorrhage * 1  0/1109 (0.00%)  1/1115 (0.09%) 
General disorders     
Chest discomfort * 1  1/1109 (0.09%)  0/1115 (0.00%) 
Infections and infestations     
Abscess * 1  1/1109 (0.09%)  0/1115 (0.00%) 
Atypical pneumonia * 1  0/1109 (0.00%)  1/1115 (0.09%) 
COVID-19 * 1  2/1109 (0.18%)  8/1115 (0.72%) 
COVID-19 pneumonia * 1  7/1109 (0.63%)  37/1115 (3.32%) 
Pneumonia * 1  1/1109 (0.09%)  11/1115 (0.99%) 
Sepsis * 1  1/1109 (0.09%)  0/1115 (0.00%) 
Injury, poisoning and procedural complications     
Craniocerebral injury * 1  0/1109 (0.00%)  1/1115 (0.09%) 
Eye injury * 1  0/1109 (0.00%)  1/1115 (0.09%) 
Hand fracture * 1  0/1109 (0.00%)  1/1115 (0.09%) 
Road traffic accident * 1  0/1109 (0.00%)  1/1115 (0.09%) 
Wrist fracture * 1  0/1109 (0.00%)  1/1115 (0.09%) 
Investigations     
Alanine aminotransferase increased * 1  0/1109 (0.00%)  1/1115 (0.09%) 
Creatinine renal clearance decreased * 1  2/1109 (0.18%)  3/1115 (0.27%) 
Fibrin D dimer increased * 1  0/1109 (0.00%)  1/1115 (0.09%) 
Haemoglobin decreased * 1  1/1109 (0.09%)  0/1115 (0.00%) 
Oxygen saturation decreased * 1  1/1109 (0.09%)  0/1115 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Colon adenoma * 1  0/1109 (0.00%)  1/1115 (0.09%) 
Nervous system disorders     
Brain stem stroke * 1  1/1109 (0.09%)  0/1115 (0.00%) 
Facial paralysis * 1  1/1109 (0.09%)  0/1115 (0.00%) 
Pregnancy, puerperium and perinatal conditions     
Abortion threatened * 1  0/1109 (0.00%)  1/1115 (0.09%) 
Respiratory, thoracic and mediastinal disorders     
Acute respiratory failure * 1  0/1109 (0.00%)  5/1115 (0.45%) 
Dyspnoea * 1  2/1109 (0.18%)  3/1115 (0.27%) 
Hypoxia * 1  0/1109 (0.00%)  2/1115 (0.18%) 
Interstitial lung disease * 1  0/1109 (0.00%)  2/1115 (0.18%) 
Pneumonitis * 1  0/1109 (0.00%)  5/1115 (0.45%) 
Pulmonary embolism * 1  0/1109 (0.00%)  2/1115 (0.18%) 
Respiratory failure * 1  0/1109 (0.00%)  1/1115 (0.09%) 
Nasal obstruction * 1  1/1109 (0.09%)  0/1115 (0.00%) 
Vascular disorders     
Hypertensive crisis * 1  1/1109 (0.09%)  0/1115 (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 0%
PF-07321332 300 mg + Ritonavir 100 mg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   262/1109 (23.62%)   241/1115 (21.61%) 
Blood and lymphatic system disorders     
Anaemia * 1  1/1109 (0.09%)  2/1115 (0.18%) 
Leukocytosis * 1  2/1109 (0.18%)  0/1115 (0.00%) 
Leukopenia * 1  2/1109 (0.18%)  2/1115 (0.18%) 
Lymphadenopathy mediastinal * 1  0/1109 (0.00%)  1/1115 (0.09%) 
Microcytic anaemia * 1  0/1109 (0.00%)  1/1115 (0.09%) 
Neutropenia * 1  0/1109 (0.00%)  2/1115 (0.18%) 
Thrombocytopenia * 1  0/1109 (0.00%)  3/1115 (0.27%) 
Cardiac disorders     
Palpitations * 1  1/1109 (0.09%)  2/1115 (0.18%) 
Pericardial effusion * 1  0/1109 (0.00%)  1/1115 (0.09%) 
Sinus bradycardia * 1  0/1109 (0.00%)  1/1115 (0.09%) 
Sinus tachycardia * 1  0/1109 (0.00%)  1/1115 (0.09%) 
Ventricular arrhythmia * 1  0/1109 (0.00%)  1/1115 (0.09%) 
Ear and labyrinth disorders     
Hyperacusis * 1  0/1109 (0.00%)  1/1115 (0.09%) 
Vertigo * 1  1/1109 (0.09%)  1/1115 (0.09%) 
Endocrine disorders     
Thyroiditis chronic * 1  0/1109 (0.00%)  1/1115 (0.09%) 
Eye disorders     
Eye pain * 1  1/1109 (0.09%)  0/1115 (0.00%) 
Gastrointestinal disorders     
Abdominal pain * 1  2/1109 (0.18%)  3/1115 (0.27%) 
Abdominal pain lower * 1  1/1109 (0.09%)  0/1115 (0.00%) 
Abdominal pain upper * 1  5/1109 (0.45%)  2/1115 (0.18%) 
Aphthous ulcer * 1  1/1109 (0.09%)  0/1115 (0.00%) 
Colitis * 1  1/1109 (0.09%)  0/1115 (0.00%) 
Constipation * 1  1/1109 (0.09%)  3/1115 (0.27%) 
Diarrhoea * 1  35/1109 (3.16%)  18/1115 (1.61%) 
Dry mouth * 1  1/1109 (0.09%)  0/1115 (0.00%) 
Dyspepsia * 1  6/1109 (0.54%)  5/1115 (0.45%) 
Faeces soft * 1  1/1109 (0.09%)  0/1115 (0.00%) 
Gastritis * 1  1/1109 (0.09%)  1/1115 (0.09%) 
Gastrooesophageal reflux disease * 1  4/1109 (0.36%)  2/1115 (0.18%) 
Hiatus hernia * 1  0/1109 (0.00%)  2/1115 (0.18%) 
Hyperchlorhydria * 1  0/1109 (0.00%)  1/1115 (0.09%) 
Large intestine polyp * 1  0/1109 (0.00%)  1/1115 (0.09%) 
Nausea * 1  16/1109 (1.44%)  19/1115 (1.70%) 
Toothache * 1  0/1109 (0.00%)  1/1115 (0.09%) 
Vomiting * 1  12/1109 (1.08%)  9/1115 (0.81%) 
General disorders     
Asthenia * 1  3/1109 (0.27%)  4/1115 (0.36%) 
Catheter site pain * 1  1/1109 (0.09%)  0/1115 (0.00%) 
Chest discomfort * 1  1/1109 (0.09%)  0/1115 (0.00%) 
Chest pain * 1  2/1109 (0.18%)  1/1115 (0.09%) 
Chills * 1  6/1109 (0.54%)  0/1115 (0.00%) 
Fatigue * 1  3/1109 (0.27%)  5/1115 (0.45%) 
Non-cardiac chest pain * 1  1/1109 (0.09%)  0/1115 (0.00%) 
Oedema due to cardiac disease * 1  1/1109 (0.09%)  0/1115 (0.00%) 
Pain * 1  0/1109 (0.00%)  3/1115 (0.27%) 
Peripheral swelling * 1  0/1109 (0.00%)  1/1115 (0.09%) 
Pyrexia * 1  8/1109 (0.72%)  7/1115 (0.63%) 
Hepatobiliary disorders     
Cholestasis * 1  1/1109 (0.09%)  0/1115 (0.00%) 
Hepatic function abnormal * 1  2/1109 (0.18%)  1/1115 (0.09%) 
Hepatic steatosis * 1  0/1109 (0.00%)  1/1115 (0.09%) 
Hepatitis toxic * 1  1/1109 (0.09%)  0/1115 (0.00%) 
Hyperbilirubinaemia * 1  1/1109 (0.09%)  0/1115 (0.00%) 
Liver injury * 1  0/1109 (0.00%)  1/1115 (0.09%) 
Steatohepatitis * 1  1/1109 (0.09%)  0/1115 (0.00%) 
Immune system disorders     
Mycotic allergy * 1  1/1109 (0.09%)  0/1115 (0.00%) 
Seasonal allergy * 1  1/1109 (0.09%)  0/1115 (0.00%) 
Infections and infestations     
Bronchitis * 1  1/1109 (0.09%)  1/1115 (0.09%) 
Bronchopulmonary aspergillosis * 1  0/1109 (0.00%)  1/1115 (0.09%) 
COVID-19 * 1  7/1109 (0.63%)  7/1115 (0.63%) 
COVID-19 pneumonia * 1  1/1109 (0.09%)  6/1115 (0.54%) 
Gastroenteritis viral * 1  0/1109 (0.00%)  1/1115 (0.09%) 
Hepatitis viral * 1  1/1109 (0.09%)  0/1115 (0.00%) 
Influenza * 1  0/1109 (0.00%)  1/1115 (0.09%) 
Mumps * 1  0/1109 (0.00%)  1/1115 (0.09%) 
Nasopharyngitis * 1  2/1109 (0.18%)  0/1115 (0.00%) 
Oral candidiasis * 1  0/1109 (0.00%)  1/1115 (0.09%) 
Oral herpes * 1  1/1109 (0.09%)  2/1115 (0.18%) 
Oropharyngeal candidiasis * 1  1/1109 (0.09%)  0/1115 (0.00%) 
Pharyngitis * 1  1/1109 (0.09%)  0/1115 (0.00%) 
Pneumonia * 1  1/1109 (0.09%)  4/1115 (0.36%) 
Pneumonia viral * 1  0/1109 (0.00%)  1/1115 (0.09%) 
Pyelonephritis chronic * 1  1/1109 (0.09%)  0/1115 (0.00%) 
Respiratory tract infection bacterial * 1  1/1109 (0.09%)  0/1115 (0.00%) 
Respiratory tract infection viral * 1  2/1109 (0.18%)  1/1115 (0.09%) 
Staphylococcal bacteraemia * 1  0/1109 (0.00%)  1/1115 (0.09%) 
Tonsillitis * 1  0/1109 (0.00%)  1/1115 (0.09%) 
Upper respiratory tract infection * 1  1/1109 (0.09%)  0/1115 (0.00%) 
Urinary tract infection * 1  1/1109 (0.09%)  1/1115 (0.09%) 
Viral rhinitis * 1  0/1109 (0.00%)  1/1115 (0.09%) 
Viral sepsis * 1  1/1109 (0.09%)  0/1115 (0.00%) 
Vulvovaginal candidiasis * 1  1/1109 (0.09%)  0/1115 (0.00%) 
Injury, poisoning and procedural complications     
Fall * 1  0/1109 (0.00%)  2/1115 (0.18%) 
Hand fracture * 1  0/1109 (0.00%)  1/1115 (0.09%) 
Ligament rupture * 1  0/1109 (0.00%)  1/1115 (0.09%) 
Meniscus injury * 1  0/1109 (0.00%)  1/1115 (0.09%) 
Investigations     
Activated partial thromboplastin time prolonged * 1  9/1109 (0.81%)  12/1115 (1.08%) 
Alanine aminotransferase increased * 1  18/1109 (1.62%)  26/1115 (2.33%) 
Aspartate aminotransferase increased * 1  11/1109 (0.99%)  14/1115 (1.26%) 
Blood albumin decreased * 1  0/1109 (0.00%)  1/1115 (0.09%) 
Blood alkaline phosphatase increased * 1  1/1109 (0.09%)  0/1115 (0.00%) 
Blood bicarbonate decreased * 1  1/1109 (0.09%)  1/1115 (0.09%) 
Blood calcium decreased * 1  0/1109 (0.00%)  1/1115 (0.09%) 
Blood calcium increased * 1  0/1109 (0.00%)  1/1115 (0.09%) 
Blood creatine phosphokinase increased * 1  2/1109 (0.18%)  5/1115 (0.45%) 
Blood creatinine decreased * 1  0/1109 (0.00%)  1/1115 (0.09%) 
Blood creatinine increased * 1  0/1109 (0.00%)  1/1115 (0.09%) 
Blood fibrinogen decreased * 1  5/1109 (0.45%)  3/1115 (0.27%) 
Blood glucose decreased * 1  1/1109 (0.09%)  0/1115 (0.00%) 
Blood glucose increased * 1  2/1109 (0.18%)  7/1115 (0.63%) 
Blood lactate dehydrogenase increased * 1  0/1109 (0.00%)  1/1115 (0.09%) 
Blood potassium decreased * 1  1/1109 (0.09%)  0/1115 (0.00%) 
Blood potassium increased * 1  1/1109 (0.09%)  0/1115 (0.00%) 
Blood pressure increased * 1  1/1109 (0.09%)  1/1115 (0.09%) 
Blood sodium decreased * 1  0/1109 (0.00%)  2/1115 (0.18%) 
Blood thyroid stimulating hormone decreased * 1  1/1109 (0.09%)  0/1115 (0.00%) 
Blood thyroid stimulating hormone increased * 1  6/1109 (0.54%)  7/1115 (0.63%) 
Blood urea increased * 1  1/1109 (0.09%)  1/1115 (0.09%) 
Breath sounds abnormal * 1  1/1109 (0.09%)  0/1115 (0.00%) 
C-reactive protein * 1  2/1109 (0.18%)  1/1115 (0.09%) 
C-reactive protein increased * 1  10/1109 (0.90%)  13/1115 (1.17%) 
Coagulation time prolonged * 1  1/1109 (0.09%)  0/1115 (0.00%) 
Creatinine renal clearance abnormal * 1  0/1109 (0.00%)  1/1115 (0.09%) 
Creatinine renal clearance decreased * 1  16/1109 (1.44%)  15/1115 (1.35%) 
Creatinine renal clearance increased * 1  1/1109 (0.09%)  1/1115 (0.09%) 
Differential white blood cell count abnormal * 1  1/1109 (0.09%)  0/1115 (0.00%) 
Fibrin D dimer * 1  1/1109 (0.09%)  0/1115 (0.00%) 
Fibrin D dimer increased * 1  25/1109 (2.25%)  31/1115 (2.78%) 
Glomerular filtration rate abnormal * 1  0/1109 (0.00%)  1/1115 (0.09%) 
Glomerular filtration rate decreased * 1  3/1109 (0.27%)  2/1115 (0.18%) 
Glycosylated haemoglobin increased * 1  0/1109 (0.00%)  1/1115 (0.09%) 
Haematocrit increased * 1  1/1109 (0.09%)  1/1115 (0.09%) 
Haemoglobin decreased * 1  1/1109 (0.09%)  0/1115 (0.00%) 
Haemoglobin increased * 1  0/1109 (0.00%)  1/1115 (0.09%) 
Haptoglobin increased * 1  4/1109 (0.36%)  3/1115 (0.27%) 
Hepatic enzyme abnormal * 1  0/1109 (0.00%)  1/1115 (0.09%) 
Hepatic enzyme increased * 1  2/1109 (0.18%)  3/1115 (0.27%) 
Hepatitis C virus test positive * 1  1/1109 (0.09%)  0/1115 (0.00%) 
International normalised ratio abnormal * 1  1/1109 (0.09%)  0/1115 (0.00%) 
International normalised ratio increased * 1  3/1109 (0.27%)  5/1115 (0.45%) 
Liver function test increased * 1  1/1109 (0.09%)  0/1115 (0.00%) 
Lymphocyte count decreased * 1  0/1109 (0.00%)  3/1115 (0.27%) 
Neutrophil count decreased * 1  0/1109 (0.00%)  2/1115 (0.18%) 
Neutrophil count increased * 1  2/1109 (0.18%)  0/1115 (0.00%) 
Oxygen saturation decreased * 1  0/1109 (0.00%)  1/1115 (0.09%) 
Platelet count decreased * 1  1/1109 (0.09%)  1/1115 (0.09%) 
Platelet count increased * 1  2/1109 (0.18%)  1/1115 (0.09%) 
Procalcitonin increased * 1  1/1109 (0.09%)  2/1115 (0.18%) 
Prothrombin time prolonged * 1  3/1109 (0.27%)  5/1115 (0.45%) 
Red blood cell count increased * 1  0/1109 (0.00%)  1/1115 (0.09%) 
Serum ferritin decreased * 1  1/1109 (0.09%)  0/1115 (0.00%) 
Serum ferritin increased * 1  2/1109 (0.18%)  6/1115 (0.54%) 
Thyroxine free increased * 1  0/1109 (0.00%)  1/1115 (0.09%) 
Thyroxine increased * 1  1/1109 (0.09%)  0/1115 (0.00%) 
Transaminases increased * 1  0/1109 (0.00%)  1/1115 (0.09%) 
Weight increased * 1  0/1109 (0.00%)  1/1115 (0.09%) 
White blood cell count decreased * 1  2/1109 (0.18%)  3/1115 (0.27%) 
White blood cell count increased * 1  2/1109 (0.18%)  0/1115 (0.00%) 
Metabolism and nutrition disorders     
Decreased appetite * 1  1/1109 (0.09%)  0/1115 (0.00%) 
Dehydration * 1  2/1109 (0.18%)  1/1115 (0.09%) 
Diabetes mellitus * 1  2/1109 (0.18%)  0/1115 (0.00%) 
Diabetes mellitus inadequate control * 1  2/1109 (0.18%)  1/1115 (0.09%) 
Glucose tolerance impaired * 1  1/1109 (0.09%)  0/1115 (0.00%) 
Gout * 1  1/1109 (0.09%)  0/1115 (0.00%) 
Hyperglycaemia * 1  3/1109 (0.27%)  4/1115 (0.36%) 
Hyperkalaemia * 1  0/1109 (0.00%)  1/1115 (0.09%) 
Hypertriglyceridaemia * 1  0/1109 (0.00%)  1/1115 (0.09%) 
Hypervolaemia * 1  0/1109 (0.00%)  1/1115 (0.09%) 
Hypokalaemia * 1  3/1109 (0.27%)  3/1115 (0.27%) 
Hypomagnesaemia * 1  0/1109 (0.00%)  1/1115 (0.09%) 
Hyponatraemia * 1  2/1109 (0.18%)  0/1115 (0.00%) 
Hypophosphataemia * 1  1/1109 (0.09%)  1/1115 (0.09%) 
Impaired fasting glucose * 1  0/1109 (0.00%)  1/1115 (0.09%) 
Lack of satiety * 1  0/1109 (0.00%)  1/1115 (0.09%) 
Type 2 diabetes mellitus * 1  1/1109 (0.09%)  4/1115 (0.36%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  3/1109 (0.27%)  1/1115 (0.09%) 
Back pain * 1  4/1109 (0.36%)  3/1115 (0.27%) 
Fibromyalgia * 1  1/1109 (0.09%)  0/1115 (0.00%) 
Intervertebral disc degeneration * 1  0/1109 (0.00%)  1/1115 (0.09%) 
Intervertebral disc protrusion * 1  0/1109 (0.00%)  1/1115 (0.09%) 
Muscle spasms * 1  0/1109 (0.00%)  2/1115 (0.18%) 
Musculoskeletal stiffness * 1  0/1109 (0.00%)  1/1115 (0.09%) 
Myalgia * 1  8/1109 (0.72%)  2/1115 (0.18%) 
Pain in extremity * 1  1/1109 (0.09%)  2/1115 (0.18%) 
Spinal osteoarthritis * 1  0/1109 (0.00%)  1/1115 (0.09%) 
Nervous system disorders     
Amnesia * 1  0/1109 (0.00%)  1/1115 (0.09%) 
Anosmia * 1  3/1109 (0.27%)  0/1115 (0.00%) 
Dizziness * 1  3/1109 (0.27%)  6/1115 (0.54%) 
Dysgeusia * 1  62/1109 (5.59%)  3/1115 (0.27%) 
Facial paralysis * 1  1/1109 (0.09%)  0/1115 (0.00%) 
Headache * 1  15/1109 (1.35%)  15/1115 (1.35%) 
Hypersomnia * 1  0/1109 (0.00%)  1/1115 (0.09%) 
Memory impairment * 1  1/1109 (0.09%)  0/1115 (0.00%) 
Paraesthesia * 1  1/1109 (0.09%)  0/1115 (0.00%) 
Parosmia * 1  1/1109 (0.09%)  0/1115 (0.00%) 
Restless legs syndrome * 1  0/1109 (0.00%)  1/1115 (0.09%) 
Syncope * 1  0/1109 (0.00%)  1/1115 (0.09%) 
Tension headache * 1  0/1109 (0.00%)  1/1115 (0.09%) 
Tremor * 1  0/1109 (0.00%)  1/1115 (0.09%) 
Vascular dementia * 1  1/1109 (0.09%)  0/1115 (0.00%) 
Product Issues     
Product after taste * 1  3/1109 (0.27%)  0/1115 (0.00%) 
Psychiatric disorders     
Anxiety * 1  3/1109 (0.27%)  1/1115 (0.09%) 
Confusional state * 1  1/1109 (0.09%)  1/1115 (0.09%) 
Depression * 1  1/1109 (0.09%)  0/1115 (0.00%) 
Insomnia * 1  2/1109 (0.18%)  2/1115 (0.18%) 
Stress * 1  0/1109 (0.00%)  1/1115 (0.09%) 
Renal and urinary disorders     
Chronic kidney disease * 1  1/1109 (0.09%)  2/1115 (0.18%) 
Nephrosclerosis * 1  0/1109 (0.00%)  1/1115 (0.09%) 
Renal impairment * 1  0/1109 (0.00%)  2/1115 (0.18%) 
Reproductive system and breast disorders     
Heavy menstrual bleeding * 1  0/1109 (0.00%)  1/1115 (0.09%) 
Intermenstrual bleeding * 1  0/1109 (0.00%)  1/1115 (0.09%) 
Vaginal haemorrhage * 1  1/1109 (0.09%)  1/1115 (0.09%) 
Respiratory, thoracic and mediastinal disorders     
Acute respiratory failure * 1  1/1109 (0.09%)  0/1115 (0.00%) 
Allergic cough * 1  1/1109 (0.09%)  0/1115 (0.00%) 
Asthma * 1  1/1109 (0.09%)  1/1115 (0.09%) 
Cough * 1  6/1109 (0.54%)  7/1115 (0.63%) 
Dyspnoea * 1  8/1109 (0.72%)  7/1115 (0.63%) 
Epistaxis * 1  1/1109 (0.09%)  1/1115 (0.09%) 
Haemoptysis * 1  1/1109 (0.09%)  0/1115 (0.00%) 
Hiccups * 1  1/1109 (0.09%)  0/1115 (0.00%) 
Hypoxia * 1  0/1109 (0.00%)  3/1115 (0.27%) 
Interstitial lung disease * 1  1/1109 (0.09%)  0/1115 (0.00%) 
Nasal congestion * 1  4/1109 (0.36%)  0/1115 (0.00%) 
Oropharyngeal pain * 1  5/1109 (0.45%)  0/1115 (0.00%) 
Pulmonary mass * 1  0/1109 (0.00%)  1/1115 (0.09%) 
Rhinorrhoea * 1  1/1109 (0.09%)  1/1115 (0.09%) 
Skin and subcutaneous tissue disorders     
Acne * 1  0/1109 (0.00%)  1/1115 (0.09%) 
Alopecia * 1  1/1109 (0.09%)  3/1115 (0.27%) 
Erythema * 1  0/1109 (0.00%)  4/1115 (0.36%) 
Hyperhidrosis * 1  1/1109 (0.09%)  0/1115 (0.00%) 
Hyperkeratosis * 1  1/1109 (0.09%)  0/1115 (0.00%) 
Pruritus * 1  1/1109 (0.09%)  0/1115 (0.00%) 
Rash * 1  2/1109 (0.18%)  3/1115 (0.27%) 
Rash maculo-papular * 1  1/1109 (0.09%)  0/1115 (0.00%) 
Skin exfoliation * 1  2/1109 (0.18%)  0/1115 (0.00%) 
Skin oedema * 1  1/1109 (0.09%)  0/1115 (0.00%) 
Urticaria * 1  0/1109 (0.00%)  2/1115 (0.18%) 
Social circumstances     
Disease risk factor * 1  1/1109 (0.09%)  0/1115 (0.00%) 
Vascular disorders     
Deep vein thrombosis * 1  0/1109 (0.00%)  1/1115 (0.09%) 
Embolism * 1  0/1109 (0.00%)  2/1115 (0.18%) 
Hyperaemia * 1  0/1109 (0.00%)  1/1115 (0.09%) 
Hypertension * 1  9/1109 (0.81%)  4/1115 (0.36%) 
Hypotension * 1  1/1109 (0.09%)  4/1115 (0.36%) 
Orthostatic hypotension * 1  0/1109 (0.00%)  1/1115 (0.09%) 
Thrombophlebitis * 1  0/1109 (0.00%)  1/1115 (0.09%) 
Vein collapse * 1  0/1109 (0.00%)  1/1115 (0.09%) 
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 the 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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT04960202    
Other Study ID Numbers: C4671005
2021-002895-38 ( EudraCT Number )
EPIC-HR ( Other Identifier: Alias Study Number )
First Submitted: July 10, 2021
First Posted: July 13, 2021
Results First Submitted: November 22, 2022
Results First Posted: February 9, 2023
Last Update Posted: February 9, 2023