Trial Outcomes & Findings for EPIC-HR: Study of Oral PF-07321332/Ritonavir Compared With Placebo in Nonhospitalized High Risk Adults With COVID-19 (NCT NCT04960202)

Last Updated: 2025-07-10

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

2091 participants

Primary outcome timeframe

From Day 1 to Day 28

Results posted on

2025-07-10

Participant Flow

2256 participants signed the informed consent form (ICF). Out of these 2256 participants, 130 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. Of the 2113 randomized subjects, only 2091 received study treatment.

Participant milestones

Participant milestones
Measure	PF-07321332 300 mg + Ritonavir 100 mg 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.	Placebo 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 Study STARTED	1038	1053
Overall Study COMPLETED	976	979
Overall Study NOT COMPLETED	62	74

Reasons for withdrawal

Reasons for withdrawal
Measure	PF-07321332 300 mg + Ritonavir 100 mg 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.	Placebo 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 Study Other	5	0
Overall Study Withdrawal by Subject	37	43
Overall Study Lost to Follow-up	20	16
Overall Study Death	0	15

Baseline Characteristics

EPIC-HR: Study of Oral PF-07321332/Ritonavir Compared With Placebo in Nonhospitalized High Risk Adults With COVID-19

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PF-07321332 300 mg + Ritonavir 100 mg n=1038 Participants 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.	Placebo n=1053 Participants 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 n=2091 Participants Total of all reporting groups
Age, Continuous	44.86 Years STANDARD_DEVIATION 15.37 • n=5 Participants	45.96 Years STANDARD_DEVIATION 15.56 • n=7 Participants	45.84 Years STANDARD_DEVIATION 15.46 • n=5 Participants
Sex: Female, Male Female	522 Participants n=5 Participants	515 Participants n=7 Participants	1037 Participants n=5 Participants
Sex: Female, Male Male	516 Participants n=5 Participants	538 Participants n=7 Participants	1054 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	425 Participants n=5 Participants	439 Participants n=7 Participants	864 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	608 Participants n=5 Participants	607 Participants n=7 Participants	1215 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	95 Participants n=5 Participants	94 Participants n=7 Participants	189 Participants n=5 Participants
Race (NIH/OMB) Asian	153 Participants n=5 Participants	156 Participants n=7 Participants	309 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	52 Participants n=5 Participants	35 Participants n=7 Participants	87 Participants n=5 Participants
Race (NIH/OMB) White	728 Participants n=5 Participants	756 Participants n=7 Participants	1484 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants

PRIMARY outcome

Timeframe: From Day 1 to Day 28

Outcome measures

Outcome measures
Measure	PF-07321332 300 mg + Ritonavir 100 mg n=671 Participants 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.	Placebo n=647 Participants 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.
Percentage of Participants With Covid-19 Related Hospitalization or Death From Any Cause Through Day 28- Modified Intent-To-Treat (mITT) Population	0.752 Percentage of participants Interval 0.313 to 1.796	6.888 Percentage of participants Interval 5.172 to 9.146

SECONDARY outcome

Timeframe: From start of study intervention (Day 1) up to end of safety follow-up (Day 34)

Population: Safety analysis set (SAS) included all participants who received at least one dose of study intervention.

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.

Outcome measures

Outcome measures
Measure	PF-07321332 300 mg + Ritonavir 100 mg n=1038 Participants 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.	Placebo n=1053 Participants 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.
Number of Participants With Treatment Emergent Adverse Events (TEAEs)	228 Participants	256 Participants

SECONDARY outcome

Timeframe: From start of study intervention (Day 1) up to end of safety follow-up (Day 34)

Population: SAS population included all participants who were randomized and took at least one dose of investigational product.

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.

Outcome measures

Outcome measures
Measure	PF-07321332 300 mg + Ritonavir 100 mg n=1038 Participants 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.	Placebo n=1053 Participants 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.
Number of Participants With AEs Leading to Discontinuation and Serious Adverse Events (SAEs) AEs leading to study discontinuation	0 Participants	13 Participants
Number of Participants With AEs Leading to Discontinuation and Serious Adverse Events (SAEs) SAEs	18 Participants	71 Participants

SECONDARY outcome

Timeframe: From Day 1 to Day 28

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.

Outcome measures

Outcome measures
Measure	PF-07321332 300 mg + Ritonavir 100 mg n=977 Participants 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.	Placebo n=989 Participants 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.
Percentage of Participants With Covid-19 Related Hospitalization or Death From Any Cause Through Day 28- Modified Intent-To-Treat 1 (mITT1) Population	0.933 Percentage of participants Interval 0.487 to 1.786	6.571 Percentage of participants Interval 5.18 to 8.318

SECONDARY outcome

Timeframe: From Day 1 (baseline) to Day 28

Population: 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.

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.

Outcome measures

Outcome measures
Measure	PF-07321332 300 mg + Ritonavir 100 mg n=666 Participants 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.	Placebo n=645 Participants 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.
Time to Sustained Alleviation of All Targeted COVID-19 Signs and Symptoms Through Day 28- mITT Population	12.00 Days Interval 12.0 to 13.0	15.00 Days Interval 13.0 to 16.0

SECONDARY outcome

Timeframe: From Day 1 (baseline) to Day 28

Population: 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.

Outcome measures

Outcome measures
Measure	PF-07321332 300 mg + Ritonavir 100 mg n=970 Participants 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.	Placebo n=986 Participants 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.
Time to Sustained Alleviation of All Targeted COVID-19 Signs and Symptoms Through Day 28- mITT1 Population	13.00 Days Interval 12.0 to 13.0	15.00 Days Interval 14.0 to 16.0

SECONDARY outcome

Timeframe: From Day 1 (baseline) to Day 28

Population: 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.

Outcome measures

Outcome measures
Measure	PF-07321332 300 mg + Ritonavir 100 mg n=1031 Participants 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.	Placebo n=1050 Participants 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.
Time to Sustained Alleviation of All Targeted COVID-19 Signs and Symptoms Through Day 28- Modified Intent-to-Treat 2 (mITT2) Population	13.00 Days Interval 12.0 to 13.0	16.00 Days Interval 15.0 to 17.0

SECONDARY outcome

Timeframe: From Day 1 to Day 28

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.

Outcome measures

Outcome measures
Measure	PF-07321332 300 mg + Ritonavir 100 mg n=666 Participants 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.	Placebo n=645 Participants 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.
Percentage of Participants With Severe Covid-19 Signs and Symptoms Through Day 28- mITT Population	18.168 Percentage of participants	20.775 Percentage of participants

SECONDARY outcome

Timeframe: From Day 1 to Day 28

Outcome measures

Outcome measures
Measure	PF-07321332 300 mg + Ritonavir 100 mg n=970 Participants 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.	Placebo n=986 Participants 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.
Percentage of Participants With Severe Covid-19 Signs and Symptoms Through Day 28- mITT1 Population	19.691 Percentage of participants	21.298 Percentage of participants

SECONDARY outcome

Timeframe: From Day 1 to Day 28

Outcome measures

Outcome measures
Measure	PF-07321332 300 mg + Ritonavir 100 mg n=1031 Participants 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.	Placebo n=1050 Participants 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.
Percentage of Participants With Severe Covid-19 Signs and Symptoms Through Day 28- mITT2 Population	20.660 Percentage of participants	21.810 Percentage of participants

SECONDARY outcome

Timeframe: From Day 1 (baseline) to Day 28

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.

Outcome measures

Outcome measures
Measure	PF-07321332 300 mg + Ritonavir 100 mg n=671 Participants 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.	Placebo n=647 Participants 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.
Time to Sustained Resolution of All Targeted COVID-19 Signs and Symptoms Through Day 28- mITT Population	16.00 Days Interval 15.0 to 17.0	18.00 Days Interval 17.0 to 20.0

SECONDARY outcome

Timeframe: From Day 1 (baseline) to Day 28

Outcome measures

Outcome measures
Measure	PF-07321332 300 mg + Ritonavir 100 mg n=977 Participants 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.	Placebo n=989 Participants 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.
Time to Sustained Resolution of All Targeted COVID-19 Signs and Symptoms Through Day 28- mITT1 Population	16.00 Days Interval 15.0 to 18.0	19.00 Days Interval 18.0 to 20.0

SECONDARY outcome

Timeframe: From Day 1 (baseline) to Day 28

Outcome measures

Outcome measures
Measure	PF-07321332 300 mg + Ritonavir 100 mg n=1038 Participants 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.	Placebo n=1053 Participants 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.
Time to Sustained Resolution of All Targeted COVID-19 Signs and Symptoms Through Day 28- mITT2 Population	17.00 Days Interval 15.0 to 18.0	19.00 Days Interval 18.0 to 20.0

SECONDARY outcome

Timeframe: From Day 1 (baseline) to Day 28

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.

Outcome measures

Outcome measures
Measure	PF-07321332 300 mg + Ritonavir 100 mg n=671 Participants 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.	Placebo n=647 Participants 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.
Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT Population Muscle or body aches	6.000 Days Interval 5.0 to 7.0	7.000 Days Interval 6.0 to 8.0
Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT Population Shortness of breath or difficulty breathing	6.000 Days Interval 5.0 to 7.0	8.000 Days Interval 6.0 to 9.0
Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT Population Chills or shivering	3.000 Days Interval 3.0 to 4.0	5.000 Days Interval 4.0 to 5.0
Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT Population Cough	8.000 Days Interval 8.0 to 9.0	10.000 Days Interval 9.0 to 11.0
Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT Population Diarrhea	4.000 Days Interval 3.0 to 6.0	4.000 Days Interval 3.0 to 6.0
Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT Population Feeling hot or feverish	3.000 Days Interval 3.0 to 4.0	5.000 Days Interval 4.0 to 5.0
Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT Population Headache	5.000 Days Interval 4.0 to 5.0	7.000 Days Interval 6.0 to 8.0
Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT Population Nausea	4.000 Days Interval 3.0 to 5.0	5.000 Days Interval 4.0 to 7.0
Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT Population Stuffy or runny nose	6.000 Days Interval 5.0 to 7.0	7.000 Days Interval 7.0 to 8.0
Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT Population Sore throat	5.000 Days Interval 4.0 to 5.0	6.000 Days Interval 5.0 to 7.0
Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT Population Vomit	3.000 Days Interval 2.0 to 4.0	3.000 Days Interval 2.0 to 5.0

SECONDARY outcome

Timeframe: From Day 1 (baseline) to Day 28

Outcome measures

Outcome measures
Measure	PF-07321332 300 mg + Ritonavir 100 mg n=977 Participants 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.	Placebo n=989 Participants 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.
Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population Muscle or body aches	6.000 Days Interval 5.0 to 7.0	7.000 Days Interval 7.0 to 8.0
Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population Shortness of breath or difficulty breathing	6.000 Days Interval 5.0 to 7.0	8.000 Days Interval 7.0 to 10.0
Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population Chills or shivering	3.000 Days Interval 3.0 to 4.0	5.000 Days Interval 4.0 to 5.0
Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population Cough	9.000 Days Interval 8.0 to 9.0	10.000 Days Interval 9.0 to 11.0
Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population Diarrhea	5.000 Days Interval 4.0 to 6.0	4.000 Days Interval 3.0 to 5.0
Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population Feeling hot or feverish	3.000 Days Interval 3.0 to 4.0	5.000 Days Interval 4.0 to 6.0
Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population Headache	5.000 Days Interval 5.0 to 6.0	7.000 Days Interval 7.0 to 8.0
Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population Nausea	5.000 Days Interval 4.0 to 6.0	6.000 Days Interval 5.0 to 7.0
Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population Stuffy or runny nose	6.000 Days Interval 5.0 to 7.0	7.000 Days Interval 7.0 to 8.0
Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population Sore throat	5.000 Days Interval 4.0 to 5.0	6.000 Days Interval 5.0 to 7.0
Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population Vomit	3.000 Days Interval 2.0 to 4.0	3.000 Days Interval 2.0 to 5.0

SECONDARY outcome

Timeframe: From Day 1 (baseline) to Day 28

Outcome measures

Outcome measures
Measure	PF-07321332 300 mg + Ritonavir 100 mg n=1038 Participants 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.	Placebo n=1053 Participants 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.
Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population Feeling hot or feverish	3.000 Days Interval 3.0 to 4.0	5.000 Days Interval 4.0 to 5.0
Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population Stuffy or runny nose	6.000 Days Interval 5.0 to 7.0	7.000 Days Interval 7.0 to 8.0
Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population Muscle or body aches	6.000 Days Interval 6.0 to 7.0	8.000 Days Interval 7.0 to 9.0
Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population Shortness of breath or difficulty breathing	6.000 Days Interval 5.0 to 7.0	9.000 Days Interval 8.0 to 10.0
Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population Chills or shivering	3.000 Days Interval 3.0 to 4.0	5.000 Days Interval 4.0 to 5.0
Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population Cough	9.000 Days Interval 8.0 to 9.0	10.000 Days Interval 9.0 to 11.0
Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population Diarrhea	5.000 Days Interval 4.0 to 6.0	4.000 Days Interval 3.0 to 5.0
Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population Headache	5.000 Days Interval 5.0 to 6.0	7.000 Days Interval 7.0 to 8.0
Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population Nausea	5.000 Days Interval 4.0 to 6.0	6.000 Days Interval 5.0 to 7.0
Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population Sore throat	5.000 Days Interval 4.0 to 5.0	6.000 Days Interval 5.0 to 7.0
Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population Vomit	3.000 Days Interval 3.0 to 4.0	3.000 Days Interval 2.0 to 5.0

SECONDARY outcome

Timeframe: From Day 1 (baseline) to Day 28

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.

Outcome measures

Outcome measures
Measure	PF-07321332 300 mg + Ritonavir 100 mg n=671 Participants 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.	Placebo n=647 Participants 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.
Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT Population Muscle or body aches	9.000 Days Interval 8.0 to 11.0	12.000 Days Interval 11.0 to 13.0
Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT Population Shortness of breath or difficulty breathing	8.000 Days Interval 7.0 to 9.0	11.000 Days Interval 10.0 to 14.0
Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT Population Chills or shivering	5.000 Days Interval 4.0 to 5.0	7.000 Days Interval 6.0 to 8.0
Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT Population Cough	13.000 Days Interval 12.0 to 13.0	15.000 Days Interval 14.0 to 16.0
Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT Population Diarrhea	6.000 Days Interval 5.0 to 8.0	6.000 Days Interval 4.0 to 9.0
Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT Population Feeling hot or feverish	5.000 Days Interval 4.0 to 5.0	7.000 Days Interval 6.0 to 8.0
Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT Population Headache	8.000 Days Interval 8.0 to 9.0	11.000 Days Interval 9.0 to 12.0
Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT Population Nausea	5.000 Days Interval 4.0 to 7.0	7.000 Days Interval 6.0 to 10.0
Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT Population Stuffy or runny nose	9.000 Days Interval 9.0 to 10.0	10.000 Days Interval 9.0 to 11.0
Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT Population Sore throat	7.000 Days Interval 6.0 to 7.0	9.000 Days Interval 8.0 to 10.0
Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT Population Vomit	3.000 Days Interval 2.0 to 5.0	3.000 Days Interval 2.0 to 5.0

SECONDARY outcome

Timeframe: From Day 1 (baseline) to Day 28

Outcome measures

Outcome measures
Measure	PF-07321332 300 mg + Ritonavir 100 mg n=977 Participants 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.	Placebo n=989 Participants 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.
Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population Muscle or body aches	9.000 Days Interval 8.0 to 10.0	12.000 Days Interval 11.0 to 13.0
Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population Shortness of breath or difficulty breathing	9.000 Days Interval 8.0 to 10.0	12.000 Days Interval 11.0 to 15.0
Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population Chills or shivering	5.000 Days Interval 4.0 to 5.0	7.000 Days Interval 6.0 to 8.0
Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population Cough	13.000 Days Interval 12.0 to 14.0	15.000 Days Interval 14.0 to 17.0
Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population Diarrhea	6.000 Days Interval 6.0 to 8.0	6.000 Days Interval 5.0 to 8.0
Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population Feeling hot or feverish	5.000 Days Due to variability of data, the number of participants with events available was not sufficient for the calculation of the limits using KM.	7.000 Days Interval 6.0 to 8.0
Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population Headache	9.000 Days Interval 8.0 to 10.0	11.000 Days Interval 10.0 to 13.0
Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population Nausea	7.000 Days Interval 6.0 to 8.0	7.000 Days Interval 6.0 to 9.0
Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population Stuffy or runny nose	9.000 Days Interval 9.0 to 10.0	10.000 Days Interval 9.0 to 11.0
Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population Sore throat	7.000 Days Interval 6.0 to 8.0	9.000 Days Interval 8.0 to 10.0
Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population Vomit	3.000 Days Interval 3.0 to 5.0	3.000 Days Interval 2.0 to 5.0

SECONDARY outcome

Timeframe: From Day 1 (baseline) to Day 28

Outcome measures

Outcome measures
Measure	PF-07321332 300 mg + Ritonavir 100 mg n=1038 Participants 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.	Placebo n=1053 Participants 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.
Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population Muscle or body aches	9.000 Days Interval 8.0 to 10.0	12.000 Days Interval 11.0 to 13.0
Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population Cough	13.000 Days Interval 12.0 to 14.0	15.000 Days Interval 14.0 to 17.0
Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population Diarrhea	6.000 Days Interval 6.0 to 8.0	6.000 Days Interval 5.0 to 8.0
Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population Feeling hot or feverish	5.000 Days Interval 5.0 to 6.0	7.000 Days Interval 6.0 to 8.0
Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population Headache	9.000 Days Interval 9.0 to 10.0	11.000 Days Interval 10.0 to 13.0
Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population Nausea	7.000 Days Interval 6.0 to 8.0	7.000 Days Interval 6.0 to 9.0
Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population Shortness of breath or difficulty breathing	9.000 Days Interval 8.0 to 10.0	13.000 Days Interval 11.0 to 15.0
Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population Chills or shivering	5.000 Days Interval 4.0 to 5.0	7.000 Days Interval 6.0 to 8.0
Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population Stuffy or runny nose	9.000 Days Interval 9.0 to 10.0	11.000 Days Interval 10.0 to 12.0
Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population Sore throat	7.000 Days Interval 6.0 to 8.0	9.000 Days Interval 8.0 to 10.0
Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population Vomit	3.000 Days Interval 3.0 to 5.0	4.000 Days Interval 3.0 to 5.0

SECONDARY outcome

Timeframe: From Day 1 (baseline) to Day 28

Population: 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.

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).

Outcome measures

Outcome measures
Measure	PF-07321332 300 mg + Ritonavir 100 mg n=666 Participants 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.	Placebo n=645 Participants 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.
Number of Participants With Progression to a Worsening Status in 1 or More Self-reported COVID-19 Associated Symptoms Through Day 28-mITT Population	507 Participants	483 Participants

SECONDARY outcome

Timeframe: From Day 1 (baseline) to Day 28

Population: 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.

Outcome measures

Outcome measures
Measure	PF-07321332 300 mg + Ritonavir 100 mg n=970 Participants 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.	Placebo n=986 Participants 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.
Number of Participants With Progression to a Worsening Status in 1 or More Self-reported COVID-19 Associated Symptoms Through Day 28-mITT1 Population	735 Participants	737 Participants

SECONDARY outcome

Timeframe: From Day 1 (baseline) to Day 28

Population: 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.

Outcome measures

Outcome measures
Measure	PF-07321332 300 mg + Ritonavir 100 mg n=1031 Participants 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.	Placebo n=1050 Participants 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.
Number of Participants With Progression to a Worsening Status in 1 or More Self-reported COVID-19 Associated Symptoms Through Day 28-mITT2 Population	787 Participants	790 Participants

SECONDARY outcome

Timeframe: Day 1, 5

Population: 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, "Number Analyzed" signifies participants evaluable for each specified timepoint.

In this outcome measure, the percentage of participants with a resting peripheral oxygen saturation \>=95% were reported.

Outcome measures

Outcome measures
Measure	PF-07321332 300 mg + Ritonavir 100 mg n=671 Participants 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.	Placebo n=647 Participants 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.
Percentage of Participants With a Resting Peripheral Oxygen Saturation >=95% at Days 1 and 5- mITT Population Day 1	93.443 Percentage of participants	91.963 Percentage of participants
Percentage of Participants With a Resting Peripheral Oxygen Saturation >=95% at Days 1 and 5- mITT Population Day 5	92.823 Percentage of participants	89.076 Percentage of participants

SECONDARY outcome

Timeframe: Day 1, 5

Population: 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.

In this outcome measure, the percentage of participants with a resting peripheral oxygen saturation \>=95% were reported.

Outcome measures

Outcome measures
Measure	PF-07321332 300 mg + Ritonavir 100 mg n=977 Participants 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.	Placebo n=989 Participants 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.
Percentage of Participants With a Resting Peripheral Oxygen Saturation >=95% at Days 1 and 5- mITT1 Population Day 1	93.347 Percentage of participants	92.214 Percentage of participants
Percentage of Participants With a Resting Peripheral Oxygen Saturation >=95% at Days 1 and 5- mITT1 Population Day 5	91.577 Percentage of participants	87.610 Percentage of participants

SECONDARY outcome

Timeframe: Day 1, 5

Population: 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.

In this outcome measure, the percentage of participants with a resting peripheral oxygen saturation \>=95% were reported.

Outcome measures

Outcome measures
Measure	PF-07321332 300 mg + Ritonavir 100 mg n=1038 Participants 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.	Placebo n=1053 Participants 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.
Percentage of Participants With a Resting Peripheral Oxygen Saturation >=95% at Days 1 and 5- mITT2 Population Day 1	93.353 Percentage of participants	91.738 Percentage of participants
Percentage of Participants With a Resting Peripheral Oxygen Saturation >=95% at Days 1 and 5- mITT2 Population Day 5	91.538 Percentage of participants	87.681 Percentage of participants

SECONDARY outcome

Timeframe: From Day 1 up to Week 24

In this outcome measure, percentage of participants with death due to any cause was presented.

Outcome measures

Outcome measures
Measure	PF-07321332 300 mg + Ritonavir 100 mg n=671 Participants 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.	Placebo n=647 Participants 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.
Percentage of Participants Who Died Through Week 24- mITT Population	0 Percentage of participants	1.7 Percentage of participants

SECONDARY outcome

Timeframe: From Day 1 up to Week 24

In this outcome measure, percentage of participants with death due to any cause was presented.

Outcome measures

Outcome measures
Measure	PF-07321332 300 mg + Ritonavir 100 mg n=977 Participants 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.	Placebo n=989 Participants 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.
Percentage of Participants Who Died Through Week 24- mITT1 Population	0 Percentage of participants	1.5 Percentage of participants

SECONDARY outcome

Timeframe: From Day 1 up to Week 24

Population: mITT2 population included all participants who were randomized and took at least one dose of study intervention.

In this outcome measure, percentage of participants with death due to any cause was presented.

Outcome measures

Outcome measures
Measure	PF-07321332 300 mg + Ritonavir 100 mg n=1038 Participants 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.	Placebo n=1053 Participants 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.
Percentage of Participants Who Died Through Week 24- mITT2 Population	0 Percentage of participants	1.4 Percentage of participants

SECONDARY outcome

Timeframe: 1 Hour post-dose on Day 1 and pre-dose on Day 5

Population: 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.

Outcome measures

Outcome measures
Measure	PF-07321332 300 mg + Ritonavir 100 mg n=772 Participants 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.	Placebo 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.
Plasma Concentration Versus Time Summary of PF-07321332 Day 1 (1 Hour post dose)	2201 Nanograms per milliliter Standard Deviation 2130.7	—
Plasma Concentration Versus Time Summary of PF-07321332 Day 5 (Pre-dose)	3087 Nanograms per milliliter Standard Deviation 2884.3	—

SECONDARY outcome

Timeframe: Baseline, Day 3, 5, 10 and 14

The viral load was measured in nasal or nasopharyngeal samples using reverse transcription polymerase chain reaction (RT-PCR).

Outcome measures

Outcome measures
Measure	PF-07321332 300 mg + Ritonavir 100 mg n=671 Participants 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.	Placebo n=647 Participants 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.
Change From Baseline in Logarithm to Base10 (Log10) Transformed Viral Load at Day 3, 5, 10 and 14- mITT Population Day 3	-1.829 Log10 copies per milliliter Standard Deviation 1.805	-1.203 Log10 copies per milliliter Standard Deviation 1.697
Change From Baseline in Logarithm to Base10 (Log10) Transformed Viral Load at Day 3, 5, 10 and 14- mITT Population Day 5	-3.244 Log10 copies per milliliter Standard Deviation 1.697	-2.923 Log10 copies per milliliter Standard Deviation 1.787
Change From Baseline in Logarithm to Base10 (Log10) Transformed Viral Load at Day 3, 5, 10 and 14- mITT Population Day 10	-4.522 Log10 copies per milliliter Standard Deviation 2.105	-3.964 Log10 copies per milliliter Standard Deviation 2.1115
Change From Baseline in Logarithm to Base10 (Log10) Transformed Viral Load at Day 3, 5, 10 and 14- mITT Population Day 14	-5.108 Log10 copies per milliliter Standard Deviation 2.141	-4.862 Log10 copies per milliliter Standard Deviation 2.121

SECONDARY outcome

Timeframe: Baseline, Day 3, 5, 10 and 14

The viral load was measured in nasal or nasopharyngeal samples using RT-PCR.

Outcome measures

Outcome measures
Measure	PF-07321332 300 mg + Ritonavir 100 mg n=977 Participants 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.	Placebo n=989 Participants 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.
Change From Baseline in Log10 Transformed Viral Load at Day 3, 5, 10 and 14- mITT1 Population Day 3	-1.790 Log10 copies per milliliter Standard Deviation 1.727	-1.182 Log10 copies per milliliter Standard Deviation 1.689
Change From Baseline in Log10 Transformed Viral Load at Day 3, 5, 10 and 14- mITT1 Population Day 5	-3.064 Log10 copies per milliliter Standard Deviation 1.708	-2.213 Log10 copies per milliliter Standard Deviation 1.754
Change From Baseline in Log10 Transformed Viral Load at Day 3, 5, 10 and 14- mITT1 Population Day 10	-4.309 Log10 copies per milliliter Standard Deviation 2.108	-3.772 Log10 copies per milliliter Standard Deviation 2.058
Change From Baseline in Log10 Transformed Viral Load at Day 3, 5, 10 and 14- mITT1 Population Day 14	-4.878 Log10 copies per milliliter Standard Deviation 2.144	-4.556 Log10 copies per milliliter Standard Deviation 2.146

SECONDARY outcome

Timeframe: Baseline, Day 3, 5, 10 and 14

The viral load was measured in nasal or nasopharyngeal samples using RT-PCR.

Outcome measures

Outcome measures
Measure	PF-07321332 300 mg + Ritonavir 100 mg n=1038 Participants 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.	Placebo n=1053 Participants 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.
Change From Baseline in Log10 Transformed Viral Load at Day 3, 5, 10 and 14- mITT2 Population Day 3	-1.828 Log10 copies per milliliter Standard Deviation 1.715	-1.178 Log10 copies per milliliter Standard Deviation 1.663
Change From Baseline in Log10 Transformed Viral Load at Day 3, 5, 10 and 14- mITT2 Population Day 5	-3.097 Log10 copies per milliliter Standard Deviation 1.692	-2.239 Log10 copies per milliliter Standard Deviation 1.741
Change From Baseline in Log10 Transformed Viral Load at Day 3, 5, 10 and 14- mITT2 Population Day 10	-4.322 Log10 copies per milliliter Standard Deviation 2.109	-3.777 Log10 copies per milliliter Standard Deviation 2.041
Change From Baseline in Log10 Transformed Viral Load at Day 3, 5, 10 and 14- mITT2 Population Day 14	-4.882 Log10 copies per milliliter Standard Deviation 2.142	-4.547 Log10 copies per milliliter Standard Deviation 2.146

SECONDARY outcome

Timeframe: From Day 1 up to Day 34

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.

Outcome measures

Outcome measures
Measure	PF-07321332 300 mg + Ritonavir 100 mg n=671 Participants 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.	Placebo n=647 Participants 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.
Number of COVID-19 Related Medical Visits- mITT Population	22 Visits	81 Visits

SECONDARY outcome

Timeframe: From Day 1 up to Day 34

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.

Outcome measures

Outcome measures
Measure	PF-07321332 300 mg + Ritonavir 100 mg n=977 Participants 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.	Placebo n=989 Participants 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.
Number of COVID-19 Related Medical Visits- mITT1 Population	40 Visits	128 Visits

SECONDARY outcome

Timeframe: From Day 1 up to Day 34

Population: mITT2 population included all participants who were randomized and took at least one dose of study intervention.

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.

Outcome measures

Outcome measures
Measure	PF-07321332 300 mg + Ritonavir 100 mg n=1038 Participants 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.	Placebo n=1053 Participants 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.
Number of COVID-19 Related Medical Visits- mITT2 Population	45 Visits	144 Visits

SECONDARY outcome

Timeframe: From Day 1 up to Day 34

Population: 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).

Outcome measures

Outcome measures
Measure	PF-07321332 300 mg + Ritonavir 100 mg n=671 Participants 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.	Placebo n=647 Participants 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.
Number of Days in Hospital and ICU for the Treatment of COVID-19- mITT Population Duration of hospitalization visits	0.088 Days Standard Deviation 1.049	0.844 Days Standard Deviation 4.535
Number of Days in Hospital and ICU for the Treatment of COVID-19- mITT Population Duration of ICU visits	0.000 Days Standard Deviation 0.000	0.179 Days Standard Deviation 2.389
Number of Days in Hospital and ICU for the Treatment of COVID-19- mITT Population Duration of non-ICU visits	0.088 Days Standard Deviation 1.049	0.666 Days Standard Deviation 3.710

SECONDARY outcome

Timeframe: From Day 1 up to Day 34

Population: 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).

Outcome measures

Outcome measures
Measure	PF-07321332 300 mg + Ritonavir 100 mg n=977 Participants 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.	Placebo n=989 Participants 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.
Number of Days in Hospital and ICU for the Treatment of COVID-19- mITT1 Population Duration of hospitalization visits	0.087 Days Standard Deviation 0.968	0.766 Days Standard Deviation 4.055
Number of Days in Hospital and ICU for the Treatment of COVID-19- mITT1 Population Duration of ICU visits	0.000 Days Standard Deviation 0.000	0.128 Days Standard Deviation 1.964
Number of Days in Hospital and ICU for the Treatment of COVID-19- mITT1 Population Duration of non-ICU visits	0.087 Days Standard Deviation 0.968	0.639 Days Standard Deviation 3.446

SECONDARY outcome

Timeframe: From Day 1 up to Day 34

Population: 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).

Outcome measures

Outcome measures
Measure	PF-07321332 300 mg + Ritonavir 100 mg n=1038 Participants 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.	Placebo n=1053 Participants 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.
Number of Days in Hospital and ICU for the Treatment of COVID-19- mITT2 Population Duration of non-ICU visits	0.092 Days Standard Deviation 0.988	0.610 Days Standard Deviation 3.350
Number of Days in Hospital and ICU for the Treatment of COVID-19- mITT2 Population Duration of hospitalization visits	0.092 Days Standard Deviation 0.988	0.729 Days Standard Deviation 3.940
Number of Days in Hospital and ICU for the Treatment of COVID-19- mITT2 Population Duration of ICU visits	0.000 Days Standard Deviation 0.000	0.121 Days Standard Deviation 1.904

Adverse Events

PF-07321332 300 mg + Ritonavir 100 mg

Serious events: 19 serious events

Other events: 234 other events

Deaths: 0 deaths

Placebo

Serious events: 72 serious events

Other events: 228 other events

Deaths: 15 deaths

Serious adverse events

Other adverse events

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER