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Clinical Trial Results:
An Interventional Efficacy and Safety, Phase 2/3, Double-Blind, 2-Arm Study to Investigate Orally Administered PF-07321332/Ritonavir Compared With Placebo in Non hospitalized Symptomatic Adult Participants With COVID-19 Who are at Increased Risk of Progressing to Severe Illness

Summary
EudraCT number	2021-002895-38
Trial protocol	ES CZ HU BG
Global end of trial date	26 Apr 2022

Results information
Results version number	v1(current)
This version publication date	10 May 2023
First version publication date	10 May 2023
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

C4671005

ISRCTN number

US NCT number

NCT04960202

WHO universal trial number (UTN)

Sponsor organisation name

Pfizer Inc.

Sponsor organisation address

235 E42nd Street, New York, United States, NY 10017

Public contact

Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com

Scientific contact

Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

06 Jun 2022

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

26 Apr 2022

Was the trial ended prematurely?

Main objective of the trial

To compare the efficacy of PF-07321332/ritonavir to placebo for the treatment of COVID-19 in non-hospitalised symptomatic adult subjects with COVID-19 who are at increased risk of progression to severe disease.

Protection of trial subjects

The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.

Background therapy

Evidence for comparator

Actual start date of recruitment

16 Jul 2021

Long term follow-up planned

Yes

Long term follow-up rationale

Safety

Long term follow-up duration

3 Months

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Argentina: 8

Country: Number of subjects enrolled

Brazil: 7

Country: Number of subjects enrolled

Bulgaria: 444

Country: Number of subjects enrolled

Colombia: 2

Country: Number of subjects enrolled

Czechia: 3

Country: Number of subjects enrolled

Hungary: 8

Country: Number of subjects enrolled

India: 191

Country: Number of subjects enrolled

Japan: 6

Country: Number of subjects enrolled

Korea, Republic of: 19

Country: Number of subjects enrolled

Malaysia: 4

Country: Number of subjects enrolled

Mexico: 258

Country: Number of subjects enrolled

Poland: 3

Country: Number of subjects enrolled

Puerto Rico: 3

Country: Number of subjects enrolled

Russian Federation: 10

Country: Number of subjects enrolled

South Africa: 13

Country: Number of subjects enrolled

Spain: 2

Country: Number of subjects enrolled

Thailand: 80

Country: Number of subjects enrolled

Turkey: 44

Country: Number of subjects enrolled

Ukraine: 203

Country: Number of subjects enrolled

United States: 783

Worldwide total number of subjects

2091

EEA total number of subjects

460

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

1828

From 65 to 84 years

263

85 years and over

Subject disposition

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Recruitment details

Screening details

2256 subjects signed the informed consent form (ICF). Out of these 2256 subjects, 130 were screen failures who did not meet the study criteria and were not enrolled. There were 13 subjects who were not screen failure but not randomized due to withdrew consent or other reasons. Of the 2113 randomised subjects, only 2091 received study treatment.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Carer, Assessor

Are arms mutually exclusive

Yes

PF-07321332 300 mg and Ritonavir 100 mg

Arm description

Subjects 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. Subjects were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.

Arm type

Experimental

Investigational medicinal product name

Ritonavir

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

100mg for every 12 hours for 5 days

Investigational medicinal product name

PF-07321332

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

300 mg every 12 hours for 5 days

Placebo

Arm description

Subjects with SARS-CoV-2 infection received placebo orally, q12h for 5 days. Subjects were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.

Arm type

Placebo

Investigational medicinal product name

Placebo for PF-07321332

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

every 12hours for 5 days

Investigational medicinal product name

Placebo for ritonavir

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

every 12hours for 5 days

Number of subjects in period 1	PF-07321332 300 mg and Ritonavir 100 mg	Placebo
Started	1038	1053
Completed	976	979
Not completed	62	74
Consent withdrawn by subject	37	43
Death	-	15
Not specified	5	-
Lost to follow-up	20	16

Baseline characteristics

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Reporting group title

PF-07321332 300 mg and Ritonavir 100 mg

Reporting group description

Reporting group title

Placebo

Reporting group description

Subjects with SARS-CoV-2 infection received placebo orally, q12h for 5 days. Subjects were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.

Reporting group values	PF-07321332 300 mg and Ritonavir 100 mg	Placebo	Total
Number of subjects	1038	1053	2091
Age categorical
Units: Subjects
In utero	0	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0	0
Newborns (0-27 days)	0	0	0
Infants and toddlers (28 days-23 months)	0	0	0
Children (2-11 years)	0	0	0
Adolescents (12-17 years)	0	0	0
Adults (18-44 years)	534	499	1033
From (45-59 years)	306	316	622
Form (60-64 years)	69	104	173
From (65-74 years)	96	103	199
more than 75 years	33	31	64
Age Continuous
Units: Years
arithmetic mean (standard deviation)	44.86 ± 15.37	45.96 ± 15.56	-
Sex: Female, Male
Units: Participants
Female	522	515	1037
Male	516	538	1054
Race
Units: Subjects
American Indian or Alaska Native	95	94	189
Asian	153	156	309
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	52	35	87
White	728	756	1484
More than one race	1	2	3
Unknown or Not Reported	9	10	19
Ethnicity
Units: Subjects
Hispanic or Latino	425	439	864
Not Hispanic or Latino	608	607	1215
Unknown or Not Reported	5	7	12

End points

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Reporting group title

PF-07321332 300 mg and Ritonavir 100 mg

Reporting group description

Reporting group title

Placebo

Reporting group description

Subjects with SARS-CoV-2 infection received placebo orally, q12h for 5 days. Subjects were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.

Primary: Percentage of Subjects With Covid-19 Related Hospitalisation or Death From any Cause Through Day 28- Modified Intent-To-Treat (mITT) Population

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End point title

Percentage of Subjects With Covid-19 Related Hospitalisation or Death From any Cause Through Day 28- Modified Intent-To-Treat (mITT) Population

End point description

Percentage of subjects 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 subjects surviving divided by the number of subjects at risk. Subjects who had the event, dropped out, or moved out were not counted as “at risk” i.e., subjects who were lost were considered “censored” and were not counted in the denominator. mITT population included all subjects who were randomised 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.

End point type

Primary

End point timeframe

From Day 1 to Day 28

End point values	PF-07321332 300 mg and Ritonavir 100 mg	Placebo
Number of subjects analysed	671	647
Units: Percentage of Subjects
number (confidence interval 95%)	0.752 (0.313 to 1.796)	6.888 (5.172 to 9.146)

PF-07321332 300 mg and Ritonavir 100 mg

Statistical analysis description

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.

Comparison groups

PF-07321332 300 mg and Ritonavir 100 mg v Placebo

Number of subjects included in analysis

1318

Analysis specification

Pre-specified

Analysis type

P-value

< 0.0001

Method

Normal approximation

Parameter type

Percentage difference

Point estimate

-6.137

Confidence interval

level

95%

sides

2-sided

lower limit

-8.208

upper limit

-4.066

Variability estimate

Standard error of the mean

Dispersion value

1.057

Secondary: Percentage of Subjects With Covid-19 Related Hospitalisation or Death From any Cause Through Day 28- Modified Intent-To-Treat 1 (mITT1) Population

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End point title

Percentage of Subjects With Covid-19 Related Hospitalisation or Death From any Cause Through Day 28- Modified Intent-To-Treat 1 (mITT1) Population

End point description

Percentage of Subjects with COVID-19 related hospitalisation or death from any cause during the first 28 days of the study was estimated using the Kaplan-Meier method. mITT1 population included all subjects who were randomised 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.

End point type

Secondary

End point timeframe

From Day 1 to Day 28

End point values	PF-07321332 300 mg and Ritonavir 100 mg	Placebo
Number of subjects analysed	977	989
Units: Percentage of Subjects
number (confidence interval 95%)	0.933 (0.487 to 1.786)	6.571 (5.180 to 8.318)

PF-07321332 300 mg and Ritonavir 100 mg

Statistical analysis description

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.

Comparison groups

PF-07321332 300 mg and Ritonavir 100 mg v Placebo

Number of subjects included in analysis

1966

Analysis specification

Pre-specified

Analysis type

P-value

< 0.0001

Method

Normal approximation

Parameter type

Percentage difference

Point estimate

-5.638

Confidence interval

level

95%

sides

2-sided

lower limit

-7.308

upper limit

-3.967

Variability estimate

Standard error of the mean

Dispersion value

0.852

Secondary: Number of Subjects With AEs Leading to Discontinuation and Serious Adverse Events (SAEs)

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End point title

Number of Subjects With AEs Leading to Discontinuation and Serious Adverse Events (SAEs)

End point description

An AE was any untoward medical occurrence in a subject, 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 hospitalisation or prolongation of existing hospitalisation; 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. SAS population included all subjects who were randomised and took at least one dose of investigational product.

End point type

Secondary

End point timeframe

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

End point values	PF-07321332 300 mg and Ritonavir 100 mg	Placebo
Number of subjects analysed	1038	1053
Units: Subjects
AEs leading to study discontinuation	0	13
SAEs	18	71

No statistical analyses for this end point

Secondary: Number of Subjects With Treatment Emergent Adverse Events (TEAEs)

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End point title

Number of Subjects With Treatment Emergent Adverse Events (TEAEs)

End point description

An adverse event (AE) was any untoward medical occurrence in a subject, 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 hospitalisation or prolongation of existing hospitalisation; 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. Safety analysis set (SAS) included all subjects who received at least one dose of study intervention.

End point type

Secondary

End point timeframe

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

End point values	PF-07321332 300 mg and Ritonavir 100 mg	Placebo
Number of subjects analysed	1038	1053
Units: Subjects	228	256

No statistical analyses for this end point

Secondary: Time to Sustained Alleviation of all Targeted COVID-19 Signs and Symptoms Through Day 28- mITT Population

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End point title

Time to Sustained Alleviation of all Targeted COVID-19 Signs and Symptoms Through Day 28- mITT Population

End point description

Sustained alleviation of all targeted COVID-19 signs/symptoms defined as event occurring on first 4 consecutive days when all symptoms scored as moderate or severe at enrollment were scored as mild or absent and those scored mild or absent at enrollment were scored as absent. First day of the 4 consecutive-day period=date of first event. Time to sustained alleviation (event)=first event date minus first dose date plus 1, for subjects with event. For subjects who completed Day 28 or discontinued study before Day 28 without sustained alleviation (censored), time=censoring date (last date on which symptom alleviation was assessed) minus first dose date plus 1 or Day 25 whichever occurred first. mITT population: all subjects who were randomised 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 "N"=subjects evaluable for this endpoint.

End point type

Secondary

End point timeframe

From Day 1 (baseline) to Day 28

End point values	PF-07321332 300 mg and Ritonavir 100 mg	Placebo
Number of subjects analysed	666	645
Units: Days
median (confidence interval 95%)	12.00 (12.00 to 13.00)	15.00 (13.00 to 16.00)

PF-07321332 300 mg and Ritonavir 100 mg

Statistical analysis description

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.

Comparison groups

PF-07321332 300 mg and Ritonavir 100 mg v Placebo

Number of subjects included in analysis

1311

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0001

Method

Cox Proportional Hazard Model

Parameter type

Hazard ratio (HR)

Point estimate

1.294

Confidence interval

level

95%

sides

2-sided

lower limit

1.136

upper limit

1.476

Secondary: Time to Sustained Alleviation of all Targeted COVID-19 Signs and Symptoms Through Day 28- mITT2 Population

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End point title

Time to Sustained Alleviation of all Targeted COVID-19 Signs and Symptoms Through Day 28- mITT2 Population

End point description

Sustained alleviation of all targeted COVID-19 signs/symptoms defined as the event occurring on the first 4 consecutive days when all symptoms scored as moderate or severe at enrollment were scored as mild or absent and those scored mild or absent at the time of enrollment were scored as absent. First day of the 4 consecutive-day period=date of first event. Time to sustained alleviation (event)=first event date minus first dose date plus 1, for subjects with event. For subjects who completed Day 28 or discontinued the study before Day 28 without sustained alleviation (censored), time=censoring date (last date on which symptom alleviation was assessed) minus first dose date plus 1 or Day 25 whichever occurred first. mITT2 population: all subjects who were randomised and took at least one dose of study intervention. Here "N"=subjects evaluable for this endpoint.

End point type

Secondary

End point timeframe

From Day 1 (baseline) to Day 28

End point values	PF-07321332 300 mg and Ritonavir 100 mg	Placebo
Number of subjects analysed	1031	1050
Units: Days
median (confidence interval 95%)	13.00 (12.00 to 13.00)	16.00 (15.00 to 17.00)

PF-07321332 300 mg and Ritonavir 100 mg

Statistical analysis description

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.

Comparison groups

PF-07321332 300 mg and Ritonavir 100 mg v Placebo

Number of subjects included in analysis

2081

Analysis specification

Pre-specified

Analysis type

P-value

< 0.0001

Method

Cox Proportional Hazard Model

Parameter type

Hazard ratio (HR)

Point estimate

1.258

Confidence interval

level

95%

sides

2-sided

lower limit

1.131

upper limit

1.4

Secondary: Time to Sustained Alleviation of all Targeted COVID-19 Signs and Symptoms Through Day 28- mITT1 Population

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End point title

Time to Sustained Alleviation of all Targeted COVID-19 Signs and Symptoms Through Day 28- mITT1 Population

End point description

Sustained alleviation of all targeted COVID-19 signs/symptoms defined as event occurring on first 4 consecutive days when all symptoms scored as moderate or severe at enrollment were scored as mild or absent and those scored mild or absent at enrollment were scored as absent. First day of the 4 consecutive-day period=date of first event. Time to sustained alleviation (event)=first event date minus first dose date plus 1, for subjects with event. For subjects who completed Day 28 or discontinued study before Day 28 without sustained alleviation (censored), time=censoring date (last date on which symptom alleviation was assessed) minus first dose date plus 1 or Day 25 whichever occurred first. mITT1 population: all subjects who were randomised 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 "N"=subjects evaluable for this endpoint.

End point type

Secondary

End point timeframe

From Day 1 (baseline) to Day 28

End point values	PF-07321332 300 mg and Ritonavir 100 mg	Placebo
Number of subjects analysed	970	986
Units: Days
median (confidence interval 95%)	13.00 (12.00 to 13.00)	15.00 (14.00 to 16.00)

PF-07321332 300 mg and Ritonavir 100 mg

Statistical analysis description

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.

Comparison groups

PF-07321332 300 mg and Ritonavir 100 mg v Placebo

Number of subjects included in analysis

1956

Analysis specification

Pre-specified

Analysis type

P-value

< 0.0001

Method

Cox Proportional Hazard Model

Parameter type

Hazard ratio (HR)

Point estimate

1.266

Confidence interval

level

95%

sides

2-sided

lower limit

1.134

upper limit

1.412

Secondary: Percentage of Subjects With Severe Covid-19 Signs and Symptoms Through Day 28- mITT2 Population

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End point title

Percentage of Subjects With Severe Covid-19 Signs and Symptoms Through Day 28- mITT2 Population

End point description

Subjects 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 subject with severe score for any targeted symptoms post-baseline was counted as severe. Percentage of subjects with severe Covid-19 signs and symptoms were reported. mITT2 population included all subjects who were randomised and took at least one dose of study intervention. Here "N"=signifies subjects evaluable for this endpoint.

End point type

Secondary

End point timeframe

From Day 1 to Day 28

End point values	PF-07321332 300 mg and Ritonavir 100 mg	Placebo
Number of subjects analysed	1031	1050
Units: Percentage of Subjects
number (not applicable)	20.660	21.810

PF-07321332 300 mg and Ritonavir 100 mg

Statistical analysis description

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).

Comparison groups

PF-07321332 300 mg and Ritonavir 100 mg v Placebo

Number of subjects included in analysis

2081

Analysis specification

Pre-specified

Analysis type

P-value

= 0.7807

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

0.969

Confidence interval

level

95%

sides

2-sided

lower limit

0.773

upper limit

1.213

Secondary: Percentage of Subjects With Severe Covid-19 Signs and Symptoms Through Day 28- mITT1 Population

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End point title

Percentage of Subjects With Severe Covid-19 Signs and Symptoms Through Day 28- mITT1 Population

End point description

Subjects 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 subject with severe score for any targeted symptoms post-baseline was counted as severe. Percentage of subjects with severe Covid-19 signs and symptoms were reported. mITT1 population: all subjects who were randomised 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 "N"=signifies subjects evaluable for this endpoint.

End point type

Secondary

End point timeframe

From Day 1 to Day 28

End point values	PF-07321332 300 mg and Ritonavir 100 mg	Placebo
Number of subjects analysed	970	986
Units: Percentage of Subjects
number (not applicable)	19.691	21.298

PF-07321332 300 mg and Ritonavir 100 mg

Statistical analysis description

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).

Comparison groups

PF-07321332 300 mg and Ritonavir 100 mg v Placebo

Number of subjects included in analysis

1956

Analysis specification

Pre-specified

Analysis type

P-value

= 0.5762

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

0.936

Confidence interval

level

95%

sides

2-sided

lower limit

0.74

upper limit

1.182

Secondary: Percentage of Subjects With Severe Covid-19 Signs and Symptoms Through Day 28- mITT Population

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End point title

Percentage of Subjects With Severe Covid-19 Signs and Symptoms Through Day 28- mITT Population

End point description

Subjects 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. Scale was reported as 0= no symptoms, 1=mild, 2=moderate and 3=severe. A subject with severe score for any targeted symptoms post-baseline was counted as severe. Percentage of subjects with severe Covid-19 signs and symptoms were reported. mITT population: all subjects who were randomised 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 "N"=signifies subjects evaluable for this endpoint.

End point type

Secondary

End point timeframe

From Day 1 to Day 28

End point values	PF-07321332 300 mg and Ritonavir 100 mg	Placebo
Number of subjects analysed	666	645
Units: Percentage of Subjects
number (not applicable)	18.168	20.775

PF-07321332 300 mg and Ritonavir 100 mg

Statistical analysis description

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).

Comparison groups

PF-07321332 300 mg and Ritonavir 100 mg v Placebo

Number of subjects included in analysis

1311

Analysis specification

Pre-specified

Analysis type

P-value

= 0.3473

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

0.871

Confidence interval

level

95%

sides

2-sided

lower limit

0.652

upper limit

1.162

Secondary: Time to Sustained Resolution of all Targeted COVID-19 Signs and Symptoms Through Day 28- mITT Population

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End point title

Time to Sustained Resolution of all Targeted COVID-19 Signs and Symptoms Through Day 28- mITT Population

End point 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 subjects with event. For subjects 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. mITT population: all subjects who were randomised 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 "N" signifies subjects evaluable for this endpoint.

End point type

Secondary

End point timeframe

From Day 1 (baseline) to Day 28

End point values	PF-07321332 300 mg and Ritonavir 100 mg	Placebo
Number of subjects analysed	686	674
Units: Days
median (confidence interval 95%)	16.00 (14.00 to 17.00)	18.00 (17.00 to 20.00)

PF-07321332 300 mg and Ritonavir 100 mg

Statistical analysis description

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.

Comparison groups

PF-07321332 300 mg and Ritonavir 100 mg v Placebo

Number of subjects included in analysis

1360

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0053

Method

Cox Proportional Hazard Model

Parameter type

Hazard ratio (HR)

Point estimate

1.219

Confidence interval

level

95%

sides

2-sided

lower limit

1.061

upper limit

1.401

Secondary: Time to Sustained Resolution of all Targeted COVID-19 Signs and Symptoms Through Day 28- mITT2 Population

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End point title

Time to Sustained Resolution of all Targeted COVID-19 Signs and Symptoms Through Day 28- mITT2 Population

End point 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 subjects with event. For subjects 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. mITT2 population: all subjects who were randomised and took at least one dose of study intervention. Here "N" =signifies subjects evaluable for this endpoint.

End point type

Secondary

End point timeframe

From Day 1 (baseline) to Day 28

End point values	PF-07321332 300 mg and Ritonavir 100 mg	Placebo
Number of subjects analysed	1031	1050
Units: Days
median (confidence interval 95%)	17.000 (15.000 to 18.000)	19.000 (18.000 to 20.000)

PF-07321332 300 mg and Ritonavir 100 mg

Statistical analysis description

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.

Comparison groups

PF-07321332 300 mg and Ritonavir 100 mg v Placebo

Number of subjects included in analysis

2081

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0021

Method

Cox Proportional Hazard Model

Parameter type

Hazard ratio (HR)

Point estimate

1.194

Confidence interval

level

95%

sides

2-sided

lower limit

1.066

upper limit

1.337

Secondary: Time to Sustained Resolution of all Targeted COVID-19 Signs and Symptoms Through Day 28- mITT1 Population

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End point title

Time to Sustained Resolution of all Targeted COVID-19 Signs and Symptoms Through Day 28- mITT1 Population

End point 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 subjects with event. For subjects 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. mITT1 population: all subjects who were randomised 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 "N" signifies subjects evaluable for this endpoint.

End point type

Secondary

End point timeframe

From Day 1 (baseline) to Day 28

End point values	PF-07321332 300 mg and Ritonavir 100 mg	Placebo
Number of subjects analysed	970	986
Units: Days
median (confidence interval 95%)	16.00 (15.00 to 18.00)	19.00 (18.00 to 20.00)

PF-07321332 300 mg and Ritonavir 100 mg

Statistical analysis description

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.

Comparison groups

PF-07321332 300 mg and Ritonavir 100 mg v Placebo

Number of subjects included in analysis

1956

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0022

Method

Cox Proportional Hazard Model

Parameter type

Hazard ratio (HR)

Point estimate

1.2

Confidence interval

level

95%

sides

2-sided

lower limit

1.068

upper limit

1.348

Secondary: Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT Population

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End point title

Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT Population

End point description

Sustained alleviation of each targeted COVID-19 signs/symptoms=event occurring on first 4 consecutive days when each symptom scored moderate or severe at enrollment were scored as mild or absent and those scored mild or absent were scored as absent. First day of 4 consecutive day period=date of first event. Time to sustained alleviation (event)=first event date - first dose date +1, for subjects with event. Subjects who completed Day 28 or discontinued study before Day 28 without sustained alleviation (censored), time=censoring date - first dose date +1 or Day 25 whichever occurred first. mITT population: randomised subjects who 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 treated <=3 days of COVID-19 onset. "N"=subjects evaluable for endpoint; "n"=subjects evaluable for each specified category.

End point type

Secondary

End point timeframe

From Day 1 (baseline) to Day 28

End point values	PF-07321332 300 mg and Ritonavir 100 mg	Placebo
Number of subjects analysed	671	647
Units: Days
median (confidence interval 95%)
Muscle or body aches (n=528,506)	6.000 (5.000 to 7.000)	7.000 (6.000 to 8.000)
Shortness of breath (n=277,290)	6.000 (5.000 to 7.000)	8.000 (6.000 to 9.000)
Chills or shivering (n=412,376)	3.000 (3.000 to 4.000)	5.000 (4.000 to 5.000)
Cough (n=539,525)	8.000 (8.000 to 9.000)	10.000 (9.000 to 11.000)
Diarrhea (n=165,143)	4.000 (3.000 to 6.000)	4.000 (3.000 to 6.000)
Feeling hot or feverish (n=420,398)	3.000 (3.000 to 4.000)	5.000 (4.000 to 5.000)
Headache (n=494,453)	5.000 (4.000 to 5.000)	7.000 (6.000 to 8.000)
Nausea (n=221,220)	4.000 (3.000 to 5.000)	5.000 (4.000 to 7.000)
Stuffy or runny nose (n=466,440)	6.000 (5.000 to 7.000)	7.000 (7.000 to 8.000)
Sore throat (n=373,347)	5.000 (4.000 to 5.000)	6.000 (5.000 to 7.000)
Vomit (n=69,70)	3.000 (2.000 to 4.000)	3.000 (2.000 to 5.000)

No statistical analyses for this end point

Secondary: Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population

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End point title

Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population

End point description

Sustained alleviation of each targeted COVID-19 signs/symptoms = event occurring on the first 4 consecutive days when each symptom scored as moderate or severe at enrollment were scored as mild or absent and those scored mild or absent at enrollment were scored as absent. First day of the 4 consecutive-day period =date of first event. Time to sustained alleviation (event) = first event date -first dose date +1, for subjects with event. For subjects who completed Day 28 or discontinued the study before Day 28 without sustained alleviation (censored), time=censoring date (last date on which symptom alleviation was assessed) - first dose date + 1 or Day 25 whichever occurred first. mITT1 population: all subjects who were randomised 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 "N"=subjects evaluable for this endpoint. Here, “n”=subjects evaluable for each specified category.

End point type

Secondary

End point timeframe

From Day 1 (baseline) to Day 28

End point values	PF-07321332 300 mg and Ritonavir 100 mg	Placebo
Number of subjects analysed	977	989
Units: Days
median (confidence interval 95%)
Muscle or body aches (n=772,778)	6.000 (5.000 to 7.000)	7.000 (7.000 to 8.000)
Shortness of breath (n=423,451)	6.000 (5.000 to 7.000)	8.000 (7.000 to 10.000)
Chills or shivering (n=584,578)	3.000 (3.000 to 4.000)	5.000 (4.000 to 5.000)
Cough (n=791,816)	9.000 (8.000 to 9.000)	10.000 (9.000 to 11.000)
Diarrhea (n=262,246)	5.000 (4.000 to 6.000)	4.000 (3.000 to 5.000)
Feeling hot or feverish (n=603,613)	3.000 (3.000 to 4.000)	5.000 (4.000 to 6.000)
Headache (n=709,709)	5.000 (5.000 to 6.000)	7.000 (7.000 to 8.000)
Nausea (n=348,363)	5.000 (4.000 to 6.000)	6.000 (5.000 to 7.000)
Stuffy or runny nose (n=690,684)	6.000 (5.000 to 7.000)	7.000 (7.000 to 8.000)
Sore throat (n=548,560)	5.000 (4.000 to 5.000)	6.000 (5.000 to 7.000)
Vomit (n=116,115)	3.000 (2.000 to 4.000)	3.000 (2.000 to 5.000)

No statistical analyses for this end point

Secondary: Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population

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End point title

Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population

End point description

Sustained alleviation of each targeted COVID-19 signs/symptoms = 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 = date of first event. Time to sustained alleviation (event)=as first event date - first dose date+ 1, for subjects with event. For subjects who completed Day 28 or discontinued the study before Day 28 without sustained alleviation (censored), time =censoring date (last date on which symptom alleviation was assessed) - first dose date +1 or Day 25 whichever occurred first. mITT2 population: all subjects who were randomised and took at least one dose of study intervention. Here, “n” = subjects evaluable for each specified category.

End point type

Secondary

End point timeframe

From Day 1 (baseline) to Day 28

End point values	PF-07321332 300 mg and Ritonavir 100 mg	Placebo
Number of subjects analysed	1038	1053
Units: Days
median (confidence interval 95%)
Muscle or body aches (n=821,830)	6.000 (6.000 to 7.000)	8.000 (7.000 to 9.000)
Shortness of breath (n=459,487)	6.000 (5.000 to 7.000)	9.000 (8.000 to 10.000)
Chills or shivering (n=627,620)	3.000 (3.000 to 4.000)	5.000 (4.000 to 5.000)
Cough (n=843,874)	9.000 (8.000 to 9.000)	10.000 (9.000 to 11.000)
Diarrhea (n=287,276)	5.000 (4.000 to 6.000)	4.000 (3.000 to 5.000)
Feeling hot or feverish (n=649,656)	3.000 (3.000 to 4.000)	5.000 (4.000 to 5.000)
Headache (n=759,760)	5.000 (5.000 to 6.000)	7.000 (7.000 to 8.000)
Nausea (n=374,390)	5.000 (4.000 to 6.000)	6.000 (5.000 to 7.000)
Stuffy or runny nose (n=739,738)	6.000 (5.000 to 7.000)	7.000 (7.000 to 8.000)
Sore throat (n=582,607)	5.000 (4.000 to 5.000)	6.000 (5.000 to 7.000)
Vomit (n=132,135)	3.000 (3.000 to 4.000)	3.000 (2.000 to 5.000)

No statistical analyses for this end point

Secondary: Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT Population

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End point title

Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT Population

End point 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 subjects with event. For subjects 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. mITT population included all subjects who were randomised 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 "N"= subjects evaluable for this endpoint. Here, “n” = subjects evaluable for each specified category.

End point type

Secondary

End point timeframe

From Day 1 (baseline) to Day 28

End point values	PF-07321332 300 mg and Ritonavir 100 mg	Placebo
Number of subjects analysed	671	647
Units: Days
median (confidence interval 95%)
Muscle or body aches (n=528,506)	9.000 (8.000 to 11.000)	12.000 (11.000 to 13.000)
Shortness of breath (n=227,290)	8.000 (7.000 to 9.000)	11.000 (10.000 to 14.000)
Chills or shivering (n=412,376)	5.000 (4.000 to 5.000)	7.000 (6.000 to 8.000)
Cough (n=539,525)	13.000 (12.000 to 13.000)	15.000 (14.000 to 16.000)
Diarrhea (n=165,143)	6.000 (5.000 to 8.000)	6.000 (4.000 to 9.000)
Feeling hot or feverish (n=420,398)	5.000 (4.000 to 5.000)	7.000 (6.000 to 8.000)
Headache (n=494,453)	8.000 (8.000 to 9.000)	11.000 (9.000 to 12.000)
Nausea (n=221,220)	5.000 (4.000 to 7.000)	7.000 (6.000 to 10.000)
Stuffy or runny nose (n=466,440)	9.000 (9.000 to 10.000)	10.000 (9.000 to 11.000)
Sore throat (n=373,347)	7.000 (6.000 to 7.000)	9.000 (8.000 to 10.000)
Vomit (n=69,70)	3.000 (2.000 to 5.000)	3.000 (2.000 to 5.000)

No statistical analyses for this end point

Secondary: Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population

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End point title

Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population

End point description

Sustained resolution was defined as when each targeted symptom was scored as absent for 4 consecutive days. Time to sustained resolution (event)= First event date - first dose date + 1, for subjects with event. For subjects who completed Day 28 or discontinued the study before Day 28 without sustained resolution (censored), time =censoring date (last date on which symptom resolution was assessed) - first dose date +1 or Day 25 whichever occurred first. mITT1 population: all subjects who were randomised 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 "N"=subjects evaluable for this endpoint. Here, “n”=Subjects evaluable for each specified category. 99999 indicates the number of subjects with events available was not sufficient for the calculation of the limits using KM.

End point type

Secondary

End point timeframe

From Day 1 (baseline) to Day 28

End point values	PF-07321332 300 mg and Ritonavir 100 mg	Placebo
Number of subjects analysed	977	989
Units: Days
median (confidence interval 95%)
Muscle or body aches (n=772,778)	9.000 (8.000 to 10.000)	12.000 (11.000 to 13.000)
Shortness of breath (n=423,451)	9.000 (8.000 to 10.000)	12.000 (11.000 to 15.000)
Chills or shivering (n=584,578)	5.000 (4.000 to 5.000)	7.000 (6.000 to 8.000)
Cough (n=791,816)	13.000 (12.000 to 14.000)	15.000 (14.000 to 17.000)
Diarrhea (n=262,246)	6.000 (6.000 to 8.000)	6.000 (5.000 to 8.000)
Feeling hot or feverish (n=603,613)	5.000 (-99999 to 99999)	7.000 (6.000 to 8.000)
Headache (n=709,709)	9.000 (8.000 to 10.000)	11.000 (10.000 to 13.000)
Nausea (n=348,363)	7.000 (6.000 to 8.000)	7.000 (6.000 to 9.000)
Stuffy or runny nose (n=690,684)	9.000 (9.000 to 10.000)	11.000 (9.000 to 11.000)
Sore throat (n=548,560)	7.000 (6.000 to 8.000)	9.000 (8.000 to 10.000)
Vomit (n=116,115)	3.000 (3.000 to 5.000)	3.000 (2.000 to 5.000)

No statistical analyses for this end point

Secondary: Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population

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End point title

Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population

End point 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. mITT2 population=all subjects who were randomized and took at least one dose of study intervention. Here, “n” = subjects evaluable for each specified category.

End point type

Secondary

End point timeframe

From Day 1 (baseline) to Day 28

End point values	PF-07321332 300 mg and Ritonavir 100 mg	Placebo
Number of subjects analysed	1038	1053
Units: Days
median (confidence interval 95%)
Muscle or body aches (n=821,830)	9.000 (8.000 to 10.000)	12.000 (11.000 to 13.000)
Shortness of breath (n=459,487)	9.000 (8.000 to 10.000)	13.000 (11.000 to 15.000)
Chills or shivering (n=627,620)	5.000 (4.000 to 5.000)	7.000 (6.000 to 8.000)
Cough (n=843,874)	13.000 (12.000 to 14.000)	15.000 (14.000 to 17.000)
Diarrhea (n=287,276)	6.000 (6.000 to 8.000)	6.000 (5.000 to 8.000)
Feeling hot or feverish (n=649,656)	5.000 (5.000 to 6.000)	7.000 (6.000 to 8.000)
Headache (n=759,760)	9.000 (9.000 to 10.000)	11.000 (10.000 to 13.000)
Nausea (n=374,390)	7.000 (6.000 to 8.000)	7.000 (6.000 to 9.000)
Stuffy or runny nose (n=739,738)	9.000 (9.000 to 10.000)	11.000 (10.000 to 12.000)
Sore throat (n=582,607)	7.000 (6.000 to 8.000)	9.000 (8.000 to 10.000)
Vomit (n=132,135)	3.000 (3.000 to 5.000)	4.000 (3.000 to 5.000)

No statistical analyses for this end point

Secondary: Number of Subjects With Progression to a Worsening Status in 1 or More Self-reported COVID-19 Associated Symptoms Through Day 28-mITT Population

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End point title

Number of Subjects With Progression to a Worsening Status in 1 or More Self-reported COVID-19 Associated Symptoms Through Day 28-mITT Population

End point description

Subjects 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).mITT population included all subjects who were randomised 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 'N' signifies subjects evaluable for this endpoint.

End point type

Secondary

End point timeframe

From Day 1 (baseline) to Day 28

End point values	PF-07321332 300 mg and Ritonavir 100 mg	Placebo
Number of subjects analysed	666	645
Units: Subjects	507	483

PF-07321332 300 mg and Ritonavir 100 mg

Statistical analysis description

Comparison groups

PF-07321332 300 mg and Ritonavir 100 mg v Placebo

Number of subjects included in analysis

1311

Analysis specification

Pre-specified

Analysis type

P-value

= 0.5293

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

1.088

Confidence interval

level

95%

sides

2-sided

lower limit

0.836

upper limit

1.416

Secondary: Number of Subjects With Progression to a Worsening Status in 1 or More Self-reported COVID-19 Associated Symptoms Through Day 28-mITT1 Population

Top of page

End point title

Number of Subjects With Progression to a Worsening Status in 1 or More Self-reported COVID-19 Associated Symptoms Through Day 28-mITT1 Population

End point description

Subjects 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).mITT1 population included all subjects who were randomised 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 'N' signifies subjects evaluable for this endpoint.

End point type

Secondary

End point timeframe

From Day 1 (baseline) to Day 28

End point values	PF-07321332 300 mg and Ritonavir 100 mg	Placebo
Number of subjects analysed	970	986
Units: Subjects	735	737

PF-07321332 300 mg and Ritonavir 100 mg

Statistical analysis description

Comparison groups

PF-07321332 300 mg and Ritonavir 100 mg v Placebo

Number of subjects included in analysis

1956

Analysis specification

Pre-specified

Analysis type

P-value

= 0.6379

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

1.053

Confidence interval

level

95%

sides

2-sided

lower limit

0.85

upper limit

1.303

Secondary: Number of Subjects With Progression to a Worsening Status in 1 or More Self-reported COVID-19 Associated Symptoms Through Day 28-mITT2 Population

Top of page

End point title

Number of Subjects With Progression to a Worsening Status in 1 or More Self-reported COVID-19 Associated Symptoms Through Day 28-mITT2 Population

End point description

Subjects 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). mITT2 population included all subjects who were randomised and took at least one dose of study intervention. Here 'N' signifies subjects evaluable for this endpoint.

End point type

Secondary

End point timeframe

From Day 1 (baseline) to Day 28

End point values	PF-07321332 300 mg and Ritonavir 100 mg	Placebo
Number of subjects analysed	1031	1050
Units: Subjects	787	790

PF-07321332 300 mg and Ritonavir 100 mg

Statistical analysis description

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).

Comparison groups

PF-07321332 300 mg and Ritonavir 100 mg v Placebo

Number of subjects included in analysis

2081

Analysis specification

Pre-specified

Analysis type

P-value

= 0.676

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

1.046

Confidence interval

level

95%

sides

2-sided

lower limit

0.848

upper limit

1.29

Secondary: Percentage of Subjects With a Resting Peripheral Oxygen Saturation >=95% at Days 1 and 5- mITT1 Population

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End point title

Percentage of Subjects With a Resting Peripheral Oxygen Saturation >=95% at Days 1 and 5- mITT1 Population

End point description

In this endpoint, the percentage of subjects with a resting peripheral oxygen saturation >=95% were reported. mITT1 population included all subjects who were randomised 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, “n” signifies subjects evaluable for each specified time point.

End point type

Secondary

End point timeframe

Day 1, 5

End point values	PF-07321332 300 mg and Ritonavir 100 mg	Placebo
Number of subjects analysed	977	989
Units: Percentage of Subjects
number (not applicable)
Day 1; n=912,912	93.347	92.214
Day 5; n=835,799	91.557	87.610

Nirmatrelvir 300 mg + Ritonavir 100 mg

Statistical analysis description

Odds ratio for Day 5 vs Day 1: Placebo

Comparison groups

PF-07321332 300 mg and Ritonavir 100 mg v Placebo

Number of subjects included in analysis

1966

Analysis specification

Pre-specified

Analysis type

Method

Breslow Day test

Parameter type

Odds ratio (OR)

Point estimate

12.452

Confidence interval

level

95%

sides

2-sided

lower limit

6.823

upper limit

22.725

PF-07321332 300 mg and Ritonavir 100 mg

Statistical analysis description

Odds ratio for Day 5 vs Day 1: PF-07321332 300 mg + Ritonavir 100 mg

Comparison groups

PF-07321332 300 mg and Ritonavir 100 mg v Placebo

Number of subjects included in analysis

1966

Analysis specification

Pre-specified

Analysis type

P-value

= 0.281

Method

Breslow-Day test

Parameter type

Odds ratio (OR)

Point estimate

20.875

Confidence interval

level

95%

sides

2-sided

lower limit

10.097

upper limit

43.156

Secondary: Percentage of Subjects With a Resting Peripheral Oxygen Saturation >=95% at Days 1 and 5- mITT Population

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End point title

Percentage of Subjects With a Resting Peripheral Oxygen Saturation >=95% at Days 1 and 5- mITT Population

End point description

In this endpoint, the percentage of subjects with a resting peripheral oxygen saturation >=95% were reported. mITT population included all subjects 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, n=signifies subjects evaluable for each specified categories.

End point type

Secondary

End point timeframe

Day 1, 5

End point values	PF-07321332 300 mg and Ritonavir 100 mg	Placebo
Number of subjects analysed	671	647
Units: Percentage of Subjects
number (not applicable)
Day 1; n=627,595	93.443	91.963
Day 5; n=582,530	92.823	89.076

PF-07321332 300 mg and Ritonavir 100 mg

Statistical analysis description

Odds ratio for Day 5 vs Day 1: Placebo

Comparison groups

PF-07321332 300 mg and Ritonavir 100 mg v Placebo

Number of subjects included in analysis

1318

Analysis specification

Pre-specified

Analysis type

Method

Breslow-Day test

Parameter type

Odds ratio (OR)

Point estimate

8.948

Confidence interval

level

95%

sides

2-sided

lower limit

4.159

upper limit

19.253

PF-07321332 300 mg and Ritonavir 100 mg

Statistical analysis description

Odds ratio for Day 5 vs Day 1: PF-07321332 300 mg + Ritonavir 100 mg

Comparison groups

PF-07321332 300 mg and Ritonavir 100 mg v Placebo

Number of subjects included in analysis

1318

Analysis specification

Pre-specified

Analysis type

P-value

= 0.1997

Method

Breslow-Day test

Parameter type

Odds ratio (OR)

Point estimate

19.4

Confidence interval

level

95%

sides

2-sided

lower limit

7.788

upper limit

48.328

Secondary: Percentage of Subjects Who Died Through Week 24- mITT Population

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End point title

Percentage of Subjects Who Died Through Week 24- mITT Population

End point description

In this endpoint, percentage of subjects with death due to any cause was presented. mITT population included all subjects who were randomised 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.

End point type

Secondary

End point timeframe

From Day 1 up to Week 24

End point values	PF-07321332 300 mg and Ritonavir 100 mg	Placebo
Number of subjects analysed	671	647
Units: Percentage of Subjects
number (not applicable)	0	1.7

No statistical analyses for this end point

Secondary: Percentage of Subjects With a Resting Peripheral Oxygen Saturation >=95% at Days 1 and 5- mITT2 Population

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End point title

Percentage of Subjects With a Resting Peripheral Oxygen Saturation >=95% at Days 1 and 5- mITT2 Population

End point description

In this endpoint, the percentage of subjects with a resting peripheral oxygen saturation >=95% were reported. mITT2 population included all subjects who were randomised and took at least one dose of study intervention. Here, “n” signifies subjects evaluable for each specified time point.

End point type

Secondary

End point timeframe

Day 1, 5

End point values	PF-07321332 300 mg and Ritonavir 100 mg	Placebo
Number of subjects analysed	1038	1053
Units: Percentage of Subjects
number (not applicable)
Day 1; n=969, 966	93.353	91.738
Day 5; n=887, 847	91.538	87.681

PF-07321332 300 mg and Ritonavir 100 mg

Statistical analysis description

Odds ratio for Day 5 vs Day 1: Placebo

Comparison groups

PF-07321332 300 mg and Ritonavir 100 mg v Placebo

Number of subjects included in analysis

2091

Analysis specification

Pre-specified

Analysis type

Method

Breslow-Day test

Parameter type

Odds ratio (OR)

Point estimate

12.036

Confidence interval

level

95%

sides

2-sided

lower limit

6.808

upper limit

21.28

PF-07321332 300 mg and Ritonavir 100 mg

Statistical analysis description

Odds ratio for Day 5 vs Day 1: PF-07321332 300 mg + Ritonavir 100 mg

Comparison groups

PF-07321332 300 mg and Ritonavir 100 mg v Placebo

Number of subjects included in analysis

2091

Analysis specification

Pre-specified

Analysis type

P-value

= 0.2226

Method

Breslow-Day test

Parameter type

Odds ratio (OR)

Point estimate

21.119

Confidence interval

level

95%

sides

2-sided

lower limit

10.412

upper limit

42.837

Secondary: Percentage of Subjects Who Died Through Week 24- mITT1 Population

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End point title

Percentage of Subjects Who Died Through Week 24- mITT1 Population

End point description

In this endpoint, percentage of Subjects with death due to any cause was presented. mITT1 population included all subjects who were randomised 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.

End point type

Secondary

End point timeframe

From Day 1 up to Week 24

End point values	PF-07321332 300 mg and Ritonavir 100 mg	Placebo
Number of subjects analysed	977	989
Units: Percentage of Subjects
number (not applicable)	0	1.5

No statistical analyses for this end point

Secondary: Change From Baseline in Logarithm to Base10 (Log10) Transformed Viral Load at Day 3, 5, 10 and 14- mITT Population

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End point title

Change From Baseline in Logarithm to Base10 (Log10) Transformed Viral Load at Day 3, 5, 10 and 14- mITT Population

End point description

The viral load was measured in nasal or nasopharyngeal samples using reverse transcription polymerase chain reaction (RT-PCR). mITT population included all subjects who were randomised 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 Subjects Analyzed" signifies subjects evaluable for this endpoint. Here, “n” signifies subjects evaluable for each specified time point.

End point type

Secondary

End point timeframe

Baseline, Day 3, 5, 10 and 14

End point values	PF-07321332 300 mg and Ritonavir 100 mg	Placebo
Number of subjects analysed	671	647
Units: Log10 copies per milliliter
arithmetic mean (standard deviation)
Day 3; n=509,498	-1.829 ± 1.805	-1.203 ± 1.697
Day 5; n=487,478	-3.244 ± 1.697	-2.293 ± 1.787
Day 10; n=482,447	-4.522 ± 2.105	-3.964 ± 2.115
Day 14; n=486,472	-5.108 ± 2.141	-4.862 ± 2.121

No statistical analyses for this end point

Secondary: Plasma Concentration Versus Time Summary of PF-07321332

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End point title

Plasma Concentration Versus Time Summary of PF-07321332 ^[1]

End point description

SAS population included all subjects who were randomized and took at least one dose of study intervention. Here "Overall Number of subjects Analyzed" signifies subjects evaluable for this endpoint. Here "n" signifies subjects evaluable for the specified time point.

End point type

Secondary

End point timeframe

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

Notes
[1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint was analyzed only for specified reporting arms.

End point values	PF-07321332 300 mg and Ritonavir 100 mg
Number of subjects analysed	772
Units: Nanograms per milliliter
arithmetic mean (standard deviation)
Day 1 (1 Hour post dose); n=267	2201 ± 2130.7
Day 5 (Pre-dose); n=505	3087 ± 2884.3

No statistical analyses for this end point

Secondary: Percentage of Subjects Who Died Through Week 24- mITT2 Population

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End point title

Percentage of Subjects Who Died Through Week 24- mITT2 Population

End point description

In this endpoint, percentage of subjects with death due to any cause was presented. mITT2 population included all subjects who were randomised and took at least one dose of study intervention.

End point type

Secondary

End point timeframe

From Day 1 up to Week 24

End point values	PF-07321332 300 mg and Ritonavir 100 mg	Placebo
Number of subjects analysed	1038	1053
Units: Percentage of Subjects
number (not applicable)	0	1.4

No statistical analyses for this end point

Secondary: Change From Baseline in Log10 Transformed Viral Load at Day 3, 5, 10 and 14- mITT2 Population

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End point title

Change From Baseline in Log10 Transformed Viral Load at Day 3, 5, 10 and 14- mITT2 Population

End point description

The viral load was measured in nasal or nasopharyngeal samples using RT-PCR. mITT2 population included all subjects who were randomised and took at least one dose of study intervention. Here, “n” signifies subjects evaluable for each specified time point.

End point type

Secondary

End point timeframe

Baseline, Day 3, 5, 10 and 14

End point values	PF-07321332 300 mg and Ritonavir 100 mg	Placebo
Number of subjects analysed	1038	1053
Units: Log10 copies per milliliter
arithmetic mean (standard deviation)
Day 3; n=766,781	-1.828 ± 1.715	-1.178 ± 1.663
Day 5; n=735,743	-3.097 ± 1.692	-2.239 ± 1.741
Day 10; n=728,712	-4.322 ± 2.109	-3.777 ± 2.041
Day 14; n=739,752	-4.882 ± 2.142	-4.547 ± 2.146

No statistical analyses for this end point

Secondary: Change From Baseline in Log10 Transformed Viral Load at Day 3, 5, 10 and 14- mITT1 Population

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End point title

Change From Baseline in Log10 Transformed Viral Load at Day 3, 5, 10 and 14- mITT1 Population

End point description

The viral load was measured in nasal or nasopharyngeal samples using RT-PCR. mITT1 population included all subjects who were randomised 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 Subjects Analyzed" signifies subjects evaluable for this endpoint. Here, “n” signifies subjects evaluable for each specified time point.

End point type

Secondary

End point timeframe

Baseline, Day 3, 5, 10 and 14

End point values	PF-07321332 300 mg and Ritonavir 100 mg	Placebo
Number of subjects analysed	977	989
Units: Log10 copies per milliliter
arithmetic mean (standard deviation)
Day 3; n=718,733	-1.790 ± 1.727	-1.182 ± 1.689
Day 5; n=688,694	-3.064 ± 1.708	-2.213 ± 1.754
Day 10; n=682,663	-4.309 ± 2.108	-3.772 ± 2.058
Day 14; n=691,698	-4.878 ± 2.144	-4.556 ± 2.146

No statistical analyses for this end point

Secondary: Number of COVID-19 Related Medical Visits- mITT2 Population

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End point title

Number of COVID-19 Related Medical Visits- mITT2 Population

End point description

Medical visits included emergency room, practitioner's office, home healthcare services, urgent care, telephone consultation, outpatient infusion center, other, COVID-19-related-hospitalisation (ICU and non-ICU stays). In this outcome measure, COVID-19-related medical visits of subjects were reported. mITT2 population included all subjects who were randomised and took at least one dose of study intervention.

End point type

Secondary

End point timeframe

From Day 1 up to Day 34

End point values	PF-07321332 300 mg and Ritonavir 100 mg	Placebo
Number of subjects analysed	1038	1053
Units: Visits	45	144

No statistical analyses for this end point

Secondary: Number of Days in Hospital and ICU for the Treatment of COVID-19- mITT Population

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End point title

Number of Days in Hospital and ICU for the Treatment of COVID-19- mITT Population

End point description

mITT population included all subjects who were randomised 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 subjects (i.e. hospitalised and non-hospitalised subjects were included).

End point type

Secondary

End point timeframe

From Day 1 up to Day 34

End point values	PF-07321332 300 mg and Ritonavir 100 mg	Placebo
Number of subjects analysed	671	647
Units: Days
arithmetic mean (standard deviation)
Duration of hospitalisation visits	0.088 ± 1.049	0.844 ± 4.535
Duration of ICU visits	0.000 ± 0.000	0.179 ± 2.389
Duration of non-ICU visits	0.088 ± 1.049	0.666 ± 3.710

No statistical analyses for this end point

Secondary: Number of COVID-19 Related Medical Visits- mITT Population

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End point title

Number of COVID-19 Related Medical Visits- mITT Population

End point description

Medical visits included emergency room, practitioner's office, home healthcare services, urgent care, telephone consultation, outpatient infusion center, other, COVID-19-related-hospitalisation (intensive care unit [ICU] and non-ICU stays). In this outcome measure, COVID-19-related medical visits of subjects were reported. mITT population included all subjects who were randomised 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.

End point type

Secondary

End point timeframe

From Day 1 up to Day 34

End point values	PF-07321332 300 mg and Ritonavir 100 mg	Placebo
Number of subjects analysed	671	647
Units: Visits	22	81

No statistical analyses for this end point

Secondary: Number of COVID-19 Related Medical Visits- mITT1 Population

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End point title

Number of COVID-19 Related Medical Visits- mITT1 Population

End point description

Medical visits included emergency room, practitioner's office, home healthcare services, urgent care, telephone consultation, outpatient infusion center, other, COVID-19-related-hospitalisation (ICU and non-ICU stays). In this outcome measure, COVID-19-related medical visits of subjects were reported. mITT1 population included all subjects who were randomised 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.

End point type

Secondary

End point timeframe

From Day 1 up to Day 34

End point values	PF-07321332 300 mg and Ritonavir 100 mg	Placebo
Number of subjects analysed	977	989
Units: Visits	40	128

No statistical analyses for this end point

Secondary: Number of Days in Hospital and ICU for the Treatment of COVID-19- mITT1 Population

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End point title

Number of Days in Hospital and ICU for the Treatment of COVID-19- mITT1 Population

End point description

mITT1 population included all subjects who were randomised 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 subjects (i.e. hospitalised and non-hospitalised subjects were included).

End point type

Secondary

End point timeframe

From Day 1 up to Day 34

End point values	PF-07321332 300 mg and Ritonavir 100 mg	Placebo
Number of subjects analysed	977	989
Units: Days
arithmetic mean (standard deviation)
Duration of hospitalisation visits	0.087 ± 0.968	0.766 ± 4.055
Duration of ICU visits	0.000 ± 0.000	0.128 ± 1.964
Duration of non-ICU visits	0.087 ± 0.968	0.639 ± 3.446

No statistical analyses for this end point

Secondary: Number of Days in Hospital and ICU for the Treatment of COVID-19- mITT2 Population

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End point title

Number of Days in Hospital and ICU for the Treatment of COVID-19- mITT2 Population

End point description

mITT2 population included all subjects who were randomised and took at least one dose of study intervention. The analysis was performed on all subjects (i.e. hospitalised and non-hospitalised subjects were included).

End point type

Secondary

End point timeframe

From Day 1 up to Day 34

End point values	PF-07321332 300 mg and Ritonavir 100 mg	Placebo
Number of subjects analysed	1038	1053
Units: Days
arithmetic mean (standard deviation)
Duration of hospitalisation visits	0.092 ± 0.988	0.729 ± 3.940
Duration of ICU visits	0.000 ± 0.000	0.121 ± 1.904
Duration of non-ICU visits	0.092 ± 0.988	0.610 ± 3.350

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

From start of study intervention at Day 1 up to end of long-term safety follow-up (Week 24)

Adverse event reporting additional 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 subject and as non-serious in another subject, or 1 subject may have experienced both serious and non-serious event during the study.

Assessment type

Non-systematic

Dictionary name

MedDRA

Dictionary version

24.1

Reporting group title

Placebo

Reporting group description

Subjects with SARS-CoV-2 infection received placebo orally, q12h for 5 days. Subjects were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.

Reporting group title

PF-07321332 300 mg + Ritonavir 100 mg

Reporting group description

Subjects 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. Subjects were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.

Serious adverse events	Placebo	PF-07321332 300 mg + Ritonavir 100 mg
Total subjects affected by serious adverse events
subjects affected / exposed	72 / 1053 (6.84%)	19 / 1038 (1.83%)
number of deaths (all causes)	15	0
number of deaths resulting from adverse events
Investigations
Oxygen saturation decreased
subjects affected / exposed	0 / 1053 (0.00%)	1 / 1038 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Haemoglobin decreased
subjects affected / exposed	0 / 1053 (0.00%)	1 / 1038 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Fibrin D dimer increased
subjects affected / exposed	1 / 1053 (0.09%)	0 / 1038 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Creatinine renal clearance decreased
subjects affected / exposed	2 / 1053 (0.19%)	1 / 1038 (0.10%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Alanine aminotransferase increased
subjects affected / exposed	1 / 1053 (0.09%)	0 / 1038 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
subjects affected / exposed	1 / 1053 (0.09%)	0 / 1038 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Injury, poisoning and procedural complications
Wrist fracture
subjects affected / exposed	1 / 1053 (0.09%)	0 / 1038 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Road traffic accident
subjects affected / exposed	1 / 1053 (0.09%)	0 / 1038 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hand fracture
subjects affected / exposed	1 / 1053 (0.09%)	0 / 1038 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Eye injury
subjects affected / exposed	1 / 1053 (0.09%)	0 / 1038 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Craniocerebral injury
subjects affected / exposed	1 / 1053 (0.09%)	0 / 1038 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular disorders
Hypertensive crisis
subjects affected / exposed	0 / 1053 (0.00%)	1 / 1038 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac disorders
Palpitations
subjects affected / exposed	0 / 1053 (0.00%)	1 / 1038 (0.10%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Nervous system disorders
Facial paralysis
subjects affected / exposed	0 / 1053 (0.00%)	1 / 1038 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Brain stem stroke
subjects affected / exposed	0 / 1053 (0.00%)	1 / 1038 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pregnancy, puerperium and perinatal conditions
Abortion threatened
subjects affected / exposed	1 / 1053 (0.09%)	0 / 1038 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Blood and lymphatic system disorders
Anaemia
subjects affected / exposed	1 / 1053 (0.09%)	0 / 1038 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
General disorders and administration site conditions
Chest discomfort
subjects affected / exposed	0 / 1053 (0.00%)	1 / 1038 (0.10%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal disorders
Rectal haemorrhage
subjects affected / exposed	1 / 1053 (0.09%)	0 / 1038 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Respiratory failure
subjects affected / exposed	1 / 1053 (0.09%)	0 / 1038 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary embolism
subjects affected / exposed	2 / 1053 (0.19%)	0 / 1038 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonitis
subjects affected / exposed	5 / 1053 (0.47%)	0 / 1038 (0.00%)
occurrences causally related to treatment / all	0 / 7	0 / 0
deaths causally related to treatment / all	0 / 2	0 / 0
Interstitial lung disease
subjects affected / exposed	2 / 1053 (0.19%)	0 / 1038 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hypoxia
subjects affected / exposed	2 / 1053 (0.19%)	0 / 1038 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Dyspnoea
subjects affected / exposed	3 / 1053 (0.28%)	2 / 1038 (0.19%)
occurrences causally related to treatment / all	0 / 3	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Acute respiratory failure
subjects affected / exposed	5 / 1053 (0.47%)	0 / 1038 (0.00%)
occurrences causally related to treatment / all	0 / 5	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Nasal obstruction
subjects affected / exposed	0 / 1053 (0.00%)	1 / 1038 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Infections and infestations
Sepsis
subjects affected / exposed	0 / 1053 (0.00%)	1 / 1038 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia
subjects affected / exposed	11 / 1053 (1.04%)	1 / 1038 (0.10%)
occurrences causally related to treatment / all	0 / 11	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Abscess
subjects affected / exposed	0 / 1053 (0.00%)	1 / 1038 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Atypical pneumonia
subjects affected / exposed	1 / 1053 (0.09%)	0 / 1038 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
COVID-19
subjects affected / exposed	7 / 1053 (0.66%)	2 / 1038 (0.19%)
occurrences causally related to treatment / all	0 / 10	0 / 2
deaths causally related to treatment / all	0 / 3	0 / 0
COVID-19 pneumonia
subjects affected / exposed	36 / 1053 (3.42%)	7 / 1038 (0.67%)
occurrences causally related to treatment / all	0 / 44	0 / 7
deaths causally related to treatment / all	0 / 8	0 / 0

Frequency threshold for reporting non-serious adverse events: 0%

Non-serious adverse events	Placebo	PF-07321332 300 mg + Ritonavir 100 mg
Total subjects affected by non serious adverse events
subjects affected / exposed	228 / 1053 (21.65%)	234 / 1038 (22.54%)
Vascular disorders
Vein collapse
subjects affected / exposed	1 / 1053 (0.09%)	0 / 1038 (0.00%)
occurrences all number	1	0
Deep vein thrombosis
subjects affected / exposed	1 / 1053 (0.09%)	0 / 1038 (0.00%)
occurrences all number	1	0
Embolism
subjects affected / exposed	2 / 1053 (0.19%)	0 / 1038 (0.00%)
occurrences all number	2	0
Hyperaemia
subjects affected / exposed	1 / 1053 (0.09%)	0 / 1038 (0.00%)
occurrences all number	1	0
Hypertension
subjects affected / exposed	4 / 1053 (0.38%)	8 / 1038 (0.77%)
occurrences all number	4	8
Hypotension
subjects affected / exposed	4 / 1053 (0.38%)	1 / 1038 (0.10%)
occurrences all number	4	1
Orthostatic hypotension
subjects affected / exposed	1 / 1053 (0.09%)	0 / 1038 (0.00%)
occurrences all number	1	0
Thrombophlebitis
subjects affected / exposed	1 / 1053 (0.09%)	0 / 1038 (0.00%)
occurrences all number	1	0
General disorders and administration site conditions
Asthenia
subjects affected / exposed	3 / 1053 (0.28%)	3 / 1038 (0.29%)
occurrences all number	3	3
Catheter site pain
subjects affected / exposed	0 / 1053 (0.00%)	1 / 1038 (0.10%)
occurrences all number	0	1
Chest discomfort
subjects affected / exposed	0 / 1053 (0.00%)	1 / 1038 (0.10%)
occurrences all number	0	1
Chest pain
subjects affected / exposed	1 / 1053 (0.09%)	2 / 1038 (0.19%)
occurrences all number	1	2
Chills
subjects affected / exposed	0 / 1053 (0.00%)	5 / 1038 (0.48%)
occurrences all number	0	5
Fatigue
subjects affected / exposed	5 / 1053 (0.47%)	2 / 1038 (0.19%)
occurrences all number	5	2
Non-cardiac chest pain
subjects affected / exposed	0 / 1053 (0.00%)	1 / 1038 (0.10%)
occurrences all number	0	1
Oedema due to cardiac disease
subjects affected / exposed	0 / 1053 (0.00%)	1 / 1038 (0.10%)
occurrences all number	0	1
Pain
subjects affected / exposed	3 / 1053 (0.28%)	0 / 1038 (0.00%)
occurrences all number	3	0
Peripheral swelling
subjects affected / exposed	1 / 1053 (0.09%)	0 / 1038 (0.00%)
occurrences all number	1	0
Pyrexia
subjects affected / exposed	7 / 1053 (0.66%)	8 / 1038 (0.77%)
occurrences all number	7	8
Immune system disorders
Mycotic allergy
subjects affected / exposed	0 / 1053 (0.00%)	1 / 1038 (0.10%)
occurrences all number	0	1
Seasonal allergy
subjects affected / exposed	0 / 1053 (0.00%)	1 / 1038 (0.10%)
occurrences all number	0	1
Social circumstances
Disease risk factor
subjects affected / exposed	0 / 1053 (0.00%)	1 / 1038 (0.10%)
occurrences all number	0	1
Reproductive system and breast disorders
Vaginal haemorrhage
subjects affected / exposed	1 / 1053 (0.09%)	1 / 1038 (0.10%)
occurrences all number	1	1
Intermenstrual bleeding
subjects affected / exposed	1 / 1053 (0.09%)	0 / 1038 (0.00%)
occurrences all number	1	0
Heavy menstrual bleeding
subjects affected / exposed	1 / 1053 (0.09%)	0 / 1038 (0.00%)
occurrences all number	1	0
Respiratory, thoracic and mediastinal disorders
Asthma
subjects affected / exposed	1 / 1053 (0.09%)	1 / 1038 (0.10%)
occurrences all number	1	1
Acute respiratory failure
subjects affected / exposed	0 / 1053 (0.00%)	1 / 1038 (0.10%)
occurrences all number	0	1
Allergic cough
subjects affected / exposed	0 / 1053 (0.00%)	1 / 1038 (0.10%)
occurrences all number	0	1
Hiccups
subjects affected / exposed	0 / 1053 (0.00%)	1 / 1038 (0.10%)
occurrences all number	0	1
Dyspnoea
subjects affected / exposed	7 / 1053 (0.66%)	7 / 1038 (0.67%)
occurrences all number	8	7
Epistaxis
subjects affected / exposed	1 / 1053 (0.09%)	1 / 1038 (0.10%)
occurrences all number	1	1
Haemoptysis
subjects affected / exposed	0 / 1053 (0.00%)	1 / 1038 (0.10%)
occurrences all number	0	1
Hypoxia
subjects affected / exposed	3 / 1053 (0.28%)	0 / 1038 (0.00%)
occurrences all number	3	0
Interstitial lung disease
subjects affected / exposed	0 / 1053 (0.00%)	1 / 1038 (0.10%)
occurrences all number	0	1
Nasal congestion
subjects affected / exposed	0 / 1053 (0.00%)	4 / 1038 (0.39%)
occurrences all number	0	4
Oropharyngeal pain
subjects affected / exposed	0 / 1053 (0.00%)	5 / 1038 (0.48%)
occurrences all number	0	5
Pulmonary mass
subjects affected / exposed	1 / 1053 (0.09%)	0 / 1038 (0.00%)
occurrences all number	1	0
Rhinorrhoea
subjects affected / exposed	1 / 1053 (0.09%)	1 / 1038 (0.10%)
occurrences all number	1	1
Cough
subjects affected / exposed	6 / 1053 (0.57%)	6 / 1038 (0.58%)
occurrences all number	6	6
Psychiatric disorders
Stress
subjects affected / exposed	1 / 1053 (0.09%)	0 / 1038 (0.00%)
occurrences all number	1	0
Insomnia
subjects affected / exposed	2 / 1053 (0.19%)	2 / 1038 (0.19%)
occurrences all number	2	2
Depression
subjects affected / exposed	0 / 1053 (0.00%)	1 / 1038 (0.10%)
occurrences all number	0	1
Confusional state
subjects affected / exposed	1 / 1053 (0.09%)	1 / 1038 (0.10%)
occurrences all number	1	1
Anxiety
subjects affected / exposed	1 / 1053 (0.09%)	3 / 1038 (0.29%)
occurrences all number	1	3
Product issues
Product after taste
subjects affected / exposed	0 / 1053 (0.00%)	3 / 1038 (0.29%)
occurrences all number	0	3
Investigations
C-reactive protein
subjects affected / exposed	1 / 1053 (0.09%)	2 / 1038 (0.19%)
occurrences all number	1	2
Activated partial thromboplastin time prolonged
subjects affected / exposed	12 / 1053 (1.14%)	9 / 1038 (0.87%)
occurrences all number	13	9
Alanine aminotransferase increased
subjects affected / exposed	26 / 1053 (2.47%)	18 / 1038 (1.73%)
occurrences all number	26	19
Aspartate aminotransferase increased
subjects affected / exposed	14 / 1053 (1.33%)	11 / 1038 (1.06%)
occurrences all number	14	12
Blood albumin decreased
subjects affected / exposed	1 / 1053 (0.09%)	0 / 1038 (0.00%)
occurrences all number	1	0
Blood alkaline phosphatase increased
subjects affected / exposed	0 / 1053 (0.00%)	1 / 1038 (0.10%)
occurrences all number	0	1
Blood bicarbonate decreased
subjects affected / exposed	1 / 1053 (0.09%)	1 / 1038 (0.10%)
occurrences all number	1	1
Blood calcium decreased
subjects affected / exposed	1 / 1053 (0.09%)	0 / 1038 (0.00%)
occurrences all number	1	0
Blood calcium increased
subjects affected / exposed	1 / 1053 (0.09%)	0 / 1038 (0.00%)
occurrences all number	1	0
Blood creatine phosphokinase increased
subjects affected / exposed	5 / 1053 (0.47%)	1 / 1038 (0.10%)
occurrences all number	5	1
Blood creatinine decreased
subjects affected / exposed	1 / 1053 (0.09%)	0 / 1038 (0.00%)
occurrences all number	1	0
Blood creatinine increased
subjects affected / exposed	1 / 1053 (0.09%)	0 / 1038 (0.00%)
occurrences all number	1	0
Blood fibrinogen decreased
subjects affected / exposed	3 / 1053 (0.28%)	5 / 1038 (0.48%)
occurrences all number	3	5
Blood glucose decreased
subjects affected / exposed	0 / 1053 (0.00%)	1 / 1038 (0.10%)
occurrences all number	0	1
Blood glucose increased
subjects affected / exposed	7 / 1053 (0.66%)	1 / 1038 (0.10%)
occurrences all number	7	2
Blood lactate dehydrogenase increased
subjects affected / exposed	1 / 1053 (0.09%)	0 / 1038 (0.00%)
occurrences all number	1	0
Blood potassium increased
subjects affected / exposed	0 / 1053 (0.00%)	1 / 1038 (0.10%)
occurrences all number	0	1
Blood pressure increased
subjects affected / exposed	1 / 1053 (0.09%)	1 / 1038 (0.10%)
occurrences all number	1	1
Blood sodium decreased
subjects affected / exposed	2 / 1053 (0.19%)	0 / 1038 (0.00%)
occurrences all number	2	0
Blood thyroid stimulating hormone decreased
subjects affected / exposed	0 / 1053 (0.00%)	1 / 1038 (0.10%)
occurrences all number	0	1
Blood thyroid stimulating hormone increased
subjects affected / exposed	7 / 1053 (0.66%)	5 / 1038 (0.48%)
occurrences all number	8	5
Blood urea increased
subjects affected / exposed	1 / 1053 (0.09%)	1 / 1038 (0.10%)
occurrences all number	1	1
Breath sounds abnormal
subjects affected / exposed	0 / 1053 (0.00%)	1 / 1038 (0.10%)
occurrences all number	0	1
C-reactive protein increased
subjects affected / exposed	13 / 1053 (1.23%)	10 / 1038 (0.96%)
occurrences all number	13	10
Coagulation time prolonged
subjects affected / exposed	0 / 1053 (0.00%)	1 / 1038 (0.10%)
occurrences all number	0	1
Creatinine renal clearance decreased
subjects affected / exposed	14 / 1053 (1.33%)	14 / 1038 (1.35%)
occurrences all number	14	15
Creatinine renal clearance increased
subjects affected / exposed	1 / 1053 (0.09%)	1 / 1038 (0.10%)
occurrences all number	1	1
Differential white blood cell count abnormal
subjects affected / exposed	0 / 1053 (0.00%)	1 / 1038 (0.10%)
occurrences all number	0	1
Fibrin D dimer
subjects affected / exposed	0 / 1053 (0.00%)	1 / 1038 (0.10%)
occurrences all number	0	2
Fibrin D dimer increased
subjects affected / exposed	30 / 1053 (2.85%)	25 / 1038 (2.41%)
occurrences all number	30	26
Glomerular filtration rate abnormal
subjects affected / exposed	1 / 1053 (0.09%)	0 / 1038 (0.00%)
occurrences all number	1	0
Glomerular filtration rate decreased
subjects affected / exposed	2 / 1053 (0.19%)	3 / 1038 (0.29%)
occurrences all number	2	3
Glycosylated haemoglobin increased
subjects affected / exposed	1 / 1053 (0.09%)	0 / 1038 (0.00%)
occurrences all number	1	0
Haematocrit increased
subjects affected / exposed	1 / 1053 (0.09%)	1 / 1038 (0.10%)
occurrences all number	1	1
Haemoglobin decreased
subjects affected / exposed	0 / 1053 (0.00%)	1 / 1038 (0.10%)
occurrences all number	0	1
Haemoglobin increased
subjects affected / exposed	1 / 1053 (0.09%)	0 / 1038 (0.00%)
occurrences all number	1	0
Haptoglobin increased
subjects affected / exposed	3 / 1053 (0.28%)	4 / 1038 (0.39%)
occurrences all number	3	4
Hepatic enzyme abnormal
subjects affected / exposed	1 / 1053 (0.09%)	0 / 1038 (0.00%)
occurrences all number	1	0
Hepatic enzyme increased
subjects affected / exposed	3 / 1053 (0.28%)	2 / 1038 (0.19%)
occurrences all number	3	2
Hepatitis C virus test positive
subjects affected / exposed	0 / 1053 (0.00%)	1 / 1038 (0.10%)
occurrences all number	0	1
International normalised ratio abnormal
subjects affected / exposed	0 / 1053 (0.00%)	1 / 1038 (0.10%)
occurrences all number	0	1
International normalised ratio increased
subjects affected / exposed	5 / 1053 (0.47%)	3 / 1038 (0.29%)
occurrences all number	5	3
Lymphocyte count decreased
subjects affected / exposed	3 / 1053 (0.28%)	0 / 1038 (0.00%)
occurrences all number	3	0
Neutrophil count decreased
subjects affected / exposed	2 / 1053 (0.19%)	0 / 1038 (0.00%)
occurrences all number	2	0
Neutrophil count increased
subjects affected / exposed	0 / 1053 (0.00%)	2 / 1038 (0.19%)
occurrences all number	0	2
Oxygen saturation decreased
subjects affected / exposed	1 / 1053 (0.09%)	0 / 1038 (0.00%)
occurrences all number	1	0
Platelet count decreased
subjects affected / exposed	1 / 1053 (0.09%)	1 / 1038 (0.10%)
occurrences all number	1	1
Platelet count increased
subjects affected / exposed	1 / 1053 (0.09%)	2 / 1038 (0.19%)
occurrences all number	1	2
Procalcitonin increased
subjects affected / exposed	2 / 1053 (0.19%)	1 / 1038 (0.10%)
occurrences all number	2	1
Prothrombin time prolonged
subjects affected / exposed	5 / 1053 (0.47%)	3 / 1038 (0.29%)
occurrences all number	5	3
Red blood cell count increased
subjects affected / exposed	1 / 1053 (0.09%)	0 / 1038 (0.00%)
occurrences all number	1	0
Serum ferritin decreased
subjects affected / exposed	0 / 1053 (0.00%)	1 / 1038 (0.10%)
occurrences all number	0	1
Serum ferritin increased
subjects affected / exposed	6 / 1053 (0.57%)	2 / 1038 (0.19%)
occurrences all number	6	2
Thyroxine free increased
subjects affected / exposed	1 / 1053 (0.09%)	0 / 1038 (0.00%)
occurrences all number	1	0
Thyroxine increased
subjects affected / exposed	0 / 1053 (0.00%)	1 / 1038 (0.10%)
occurrences all number	0	1
Transaminases increased
subjects affected / exposed	1 / 1053 (0.09%)	0 / 1038 (0.00%)
occurrences all number	1	0
White blood cell count increased
subjects affected / exposed	0 / 1053 (0.00%)	2 / 1038 (0.19%)
occurrences all number	0	2
White blood cell count decreased
subjects affected / exposed	3 / 1053 (0.28%)	2 / 1038 (0.19%)
occurrences all number	3	2
Weight increased
subjects affected / exposed	1 / 1053 (0.09%)	0 / 1038 (0.00%)
occurrences all number	1	0
Injury, poisoning and procedural complications
Fall
subjects affected / exposed	2 / 1053 (0.19%)	0 / 1038 (0.00%)
occurrences all number	2	0
Hand fracture
subjects affected / exposed	1 / 1053 (0.09%)	0 / 1038 (0.00%)
occurrences all number	1	0
Ligament rupture
subjects affected / exposed	1 / 1053 (0.09%)	0 / 1038 (0.00%)
occurrences all number	1	0
Meniscus injury
subjects affected / exposed	1 / 1053 (0.09%)	0 / 1038 (0.00%)
occurrences all number	1	0
Cardiac disorders
Palpitations
subjects affected / exposed	2 / 1053 (0.19%)	1 / 1038 (0.10%)
occurrences all number	2	1
Pericardial effusion
subjects affected / exposed	1 / 1053 (0.09%)	0 / 1038 (0.00%)
occurrences all number	1	0
Sinus bradycardia
subjects affected / exposed	1 / 1053 (0.09%)	0 / 1038 (0.00%)
occurrences all number	1	0
Sinus tachycardia
subjects affected / exposed	1 / 1053 (0.09%)	0 / 1038 (0.00%)
occurrences all number	1	0
Ventricular arrhythmia
subjects affected / exposed	1 / 1053 (0.09%)	0 / 1038 (0.00%)
occurrences all number	1	0
Nervous system disorders
Vascular dementia
subjects affected / exposed	0 / 1053 (0.00%)	1 / 1038 (0.10%)
occurrences all number	0	1
Tremor
subjects affected / exposed	1 / 1053 (0.09%)	0 / 1038 (0.00%)
occurrences all number	1	0
Tension headache
subjects affected / exposed	1 / 1053 (0.09%)	0 / 1038 (0.00%)
occurrences all number	1	0
Syncope
subjects affected / exposed	1 / 1053 (0.09%)	0 / 1038 (0.00%)
occurrences all number	1	0
Restless legs syndrome
subjects affected / exposed	1 / 1053 (0.09%)	0 / 1038 (0.00%)
occurrences all number	1	0
Parosmia
subjects affected / exposed	0 / 1053 (0.00%)	1 / 1038 (0.10%)
occurrences all number	0	1
Paraesthesia
subjects affected / exposed	0 / 1053 (0.00%)	1 / 1038 (0.10%)
occurrences all number	0	1
Memory impairment
subjects affected / exposed	0 / 1053 (0.00%)	1 / 1038 (0.10%)
occurrences all number	0	1
Hypersomnia
subjects affected / exposed	1 / 1053 (0.09%)	0 / 1038 (0.00%)
occurrences all number	1	0
Headache
subjects affected / exposed	13 / 1053 (1.23%)	12 / 1038 (1.16%)
occurrences all number	13	17
Facial paralysis
subjects affected / exposed	0 / 1053 (0.00%)	1 / 1038 (0.10%)
occurrences all number	0	1
Dysgeusia
subjects affected / exposed	1 / 1053 (0.09%)	48 / 1038 (4.62%)
occurrences all number	1	48
Dizziness
subjects affected / exposed	5 / 1053 (0.47%)	3 / 1038 (0.29%)
occurrences all number	5	3
Anosmia
subjects affected / exposed	0 / 1053 (0.00%)	3 / 1038 (0.29%)
occurrences all number	0	3
Amnesia
subjects affected / exposed	1 / 1053 (0.09%)	0 / 1038 (0.00%)
occurrences all number	1	0
Blood and lymphatic system disorders
Anaemia
subjects affected / exposed	2 / 1053 (0.19%)	1 / 1038 (0.10%)
occurrences all number	2	1
Leukopenia
subjects affected / exposed	2 / 1053 (0.19%)	2 / 1038 (0.19%)
occurrences all number	2	2
Lymphadenopathy mediastinal
subjects affected / exposed	1 / 1053 (0.09%)	0 / 1038 (0.00%)
occurrences all number	1	0
Microcytic anaemia
subjects affected / exposed	1 / 1053 (0.09%)	0 / 1038 (0.00%)
occurrences all number	1	0
Neutropenia
subjects affected / exposed	2 / 1053 (0.19%)	0 / 1038 (0.00%)
occurrences all number	2	0
Thrombocytopenia
subjects affected / exposed	3 / 1053 (0.28%)	0 / 1038 (0.00%)
occurrences all number	3	0
Leukocytosis
subjects affected / exposed	0 / 1053 (0.00%)	2 / 1038 (0.19%)
occurrences all number	0	2
Ear and labyrinth disorders
Hyperacusis
subjects affected / exposed	1 / 1053 (0.09%)	0 / 1038 (0.00%)
occurrences all number	1	0
Vertigo
subjects affected / exposed	1 / 1053 (0.09%)	1 / 1038 (0.10%)
occurrences all number	1	1
Eye disorders
Eye pain
subjects affected / exposed	0 / 1053 (0.00%)	1 / 1038 (0.10%)
occurrences all number	0	1
Gastrointestinal disorders
Abdominal pain lower
subjects affected / exposed	0 / 1053 (0.00%)	1 / 1038 (0.10%)
occurrences all number	0	1
Abdominal pain
subjects affected / exposed	3 / 1053 (0.28%)	2 / 1038 (0.19%)
occurrences all number	3	2
Abdominal pain upper
subjects affected / exposed	2 / 1053 (0.19%)	5 / 1038 (0.48%)
occurrences all number	2	5
Colitis
subjects affected / exposed	0 / 1053 (0.00%)	1 / 1038 (0.10%)
occurrences all number	0	1
Constipation
subjects affected / exposed	3 / 1053 (0.28%)	1 / 1038 (0.10%)
occurrences all number	3	1
Diarrhoea
subjects affected / exposed	16 / 1053 (1.52%)	31 / 1038 (2.99%)
occurrences all number	19	32
Dyspepsia
subjects affected / exposed	4 / 1053 (0.38%)	4 / 1038 (0.39%)
occurrences all number	4	4
Faeces soft
subjects affected / exposed	0 / 1053 (0.00%)	1 / 1038 (0.10%)
occurrences all number	0	1
Gastritis
subjects affected / exposed	1 / 1053 (0.09%)	1 / 1038 (0.10%)
occurrences all number	1	1
Gastrooesophageal reflux disease
subjects affected / exposed	1 / 1053 (0.09%)	2 / 1038 (0.19%)
occurrences all number	1	2
Hiatus hernia
subjects affected / exposed	2 / 1053 (0.19%)	0 / 1038 (0.00%)
occurrences all number	2	0
Hyperchlorhydria
subjects affected / exposed	1 / 1053 (0.09%)	0 / 1038 (0.00%)
occurrences all number	1	0
Large intestine polyp
subjects affected / exposed	1 / 1053 (0.09%)	0 / 1038 (0.00%)
occurrences all number	1	0
Nausea
subjects affected / exposed	19 / 1053 (1.80%)	15 / 1038 (1.45%)
occurrences all number	20	16
Toothache
subjects affected / exposed	1 / 1053 (0.09%)	0 / 1038 (0.00%)
occurrences all number	1	0
Vomiting
subjects affected / exposed	9 / 1053 (0.85%)	12 / 1038 (1.16%)
occurrences all number	9	12
Aphthous ulcer
subjects affected / exposed	0 / 1053 (0.00%)	1 / 1038 (0.10%)
occurrences all number	0	1
Hepatobiliary disorders
Hepatic function abnormal
subjects affected / exposed	1 / 1053 (0.09%)	2 / 1038 (0.19%)
occurrences all number	1	2
Cholestasis
subjects affected / exposed	0 / 1053 (0.00%)	1 / 1038 (0.10%)
occurrences all number	0	1
Hepatic steatosis
subjects affected / exposed	1 / 1053 (0.09%)	0 / 1038 (0.00%)
occurrences all number	1	0
Hyperbilirubinaemia
subjects affected / exposed	0 / 1053 (0.00%)	1 / 1038 (0.10%)
occurrences all number	0	1
Liver injury
subjects affected / exposed	1 / 1053 (0.09%)	0 / 1038 (0.00%)
occurrences all number	1	0
Steatohepatitis
subjects affected / exposed	0 / 1053 (0.00%)	1 / 1038 (0.10%)
occurrences all number	0	1
Hepatitis toxic
subjects affected / exposed	0 / 1053 (0.00%)	1 / 1038 (0.10%)
occurrences all number	0	1
Skin and subcutaneous tissue disorders
Acne
subjects affected / exposed	1 / 1053 (0.09%)	0 / 1038 (0.00%)
occurrences all number	1	0
Alopecia
subjects affected / exposed	3 / 1053 (0.28%)	1 / 1038 (0.10%)
occurrences all number	3	1
Erythema
subjects affected / exposed	4 / 1053 (0.38%)	0 / 1038 (0.00%)
occurrences all number	4	0
Hyperhidrosis
subjects affected / exposed	0 / 1053 (0.00%)	1 / 1038 (0.10%)
occurrences all number	0	2
Hyperkeratosis
subjects affected / exposed	0 / 1053 (0.00%)	1 / 1038 (0.10%)
occurrences all number	0	1
Pruritus
subjects affected / exposed	0 / 1053 (0.00%)	1 / 1038 (0.10%)
occurrences all number	0	1
Rash
subjects affected / exposed	3 / 1053 (0.28%)	2 / 1038 (0.19%)
occurrences all number	3	2
Rash maculo-papular
subjects affected / exposed	0 / 1053 (0.00%)	1 / 1038 (0.10%)
occurrences all number	0	1
Skin exfoliation
subjects affected / exposed	0 / 1053 (0.00%)	2 / 1038 (0.19%)
occurrences all number	0	2
Skin oedema
subjects affected / exposed	0 / 1053 (0.00%)	1 / 1038 (0.10%)
occurrences all number	0	1
Urticaria
subjects affected / exposed	2 / 1053 (0.19%)	0 / 1038 (0.00%)
occurrences all number	2	0
Renal and urinary disorders
Renal impairment
subjects affected / exposed	2 / 1053 (0.19%)	0 / 1038 (0.00%)
occurrences all number	2	0
Nephrosclerosis
subjects affected / exposed	1 / 1053 (0.09%)	0 / 1038 (0.00%)
occurrences all number	1	0
Chronic kidney disease
subjects affected / exposed	2 / 1053 (0.19%)	1 / 1038 (0.10%)
occurrences all number	2	1
Endocrine disorders
Thyroiditis chronic
subjects affected / exposed	1 / 1053 (0.09%)	0 / 1038 (0.00%)
occurrences all number	1	0
Musculoskeletal and connective tissue disorders
Pain in extremity
subjects affected / exposed	1 / 1053 (0.09%)	1 / 1038 (0.10%)
occurrences all number	1	1
Myalgia
subjects affected / exposed	1 / 1053 (0.09%)	7 / 1038 (0.67%)
occurrences all number	1	7
Musculoskeletal stiffness
subjects affected / exposed	1 / 1053 (0.09%)	0 / 1038 (0.00%)
occurrences all number	1	0
Muscle spasms
subjects affected / exposed	2 / 1053 (0.19%)	0 / 1038 (0.00%)
occurrences all number	2	0
Intervertebral disc protrusion
subjects affected / exposed	1 / 1053 (0.09%)	0 / 1038 (0.00%)
occurrences all number	1	0
Intervertebral disc degeneration
subjects affected / exposed	1 / 1053 (0.09%)	0 / 1038 (0.00%)
occurrences all number	1	0
Fibromyalgia
subjects affected / exposed	0 / 1053 (0.00%)	1 / 1038 (0.10%)
occurrences all number	0	1
Back pain
subjects affected / exposed	3 / 1053 (0.28%)	2 / 1038 (0.19%)
occurrences all number	3	2
Arthralgia
subjects affected / exposed	1 / 1053 (0.09%)	3 / 1038 (0.29%)
occurrences all number	1	4
Spinal osteoarthritis
subjects affected / exposed	1 / 1053 (0.09%)	0 / 1038 (0.00%)
occurrences all number	1	0
Infections and infestations
Urinary tract infection
subjects affected / exposed	1 / 1053 (0.09%)	1 / 1038 (0.10%)
occurrences all number	1	1
Bronchitis
subjects affected / exposed	1 / 1053 (0.09%)	1 / 1038 (0.10%)
occurrences all number	1	1
Bronchopulmonary aspergillosis
subjects affected / exposed	1 / 1053 (0.09%)	0 / 1038 (0.00%)
occurrences all number	1	0
COVID-19
subjects affected / exposed	7 / 1053 (0.66%)	7 / 1038 (0.67%)
occurrences all number	7	7
COVID-19 pneumonia
subjects affected / exposed	6 / 1053 (0.57%)	1 / 1038 (0.10%)
occurrences all number	6	1
Gastroenteritis viral
subjects affected / exposed	1 / 1053 (0.09%)	0 / 1038 (0.00%)
occurrences all number	1	0
Hepatitis viral
subjects affected / exposed	0 / 1053 (0.00%)	1 / 1038 (0.10%)
occurrences all number	0	1
Influenza
subjects affected / exposed	1 / 1053 (0.09%)	0 / 1038 (0.00%)
occurrences all number	1	0
Mumps
subjects affected / exposed	1 / 1053 (0.09%)	0 / 1038 (0.00%)
occurrences all number	1	0
Nasopharyngitis
subjects affected / exposed	0 / 1053 (0.00%)	1 / 1038 (0.10%)
occurrences all number	0	1
Oral candidiasis
subjects affected / exposed	1 / 1053 (0.09%)	0 / 1038 (0.00%)
occurrences all number	1	0
Oral herpes
subjects affected / exposed	2 / 1053 (0.19%)	1 / 1038 (0.10%)
occurrences all number	2	1
Oropharyngeal candidiasis
subjects affected / exposed	0 / 1053 (0.00%)	1 / 1038 (0.10%)
occurrences all number	0	1
Pharyngitis
subjects affected / exposed	0 / 1053 (0.00%)	1 / 1038 (0.10%)
occurrences all number	0	1
Pneumonia
subjects affected / exposed	4 / 1053 (0.38%)	1 / 1038 (0.10%)
occurrences all number	4	1
Pneumonia viral
subjects affected / exposed	1 / 1053 (0.09%)	0 / 1038 (0.00%)
occurrences all number	1	0
Pyelonephritis chronic
subjects affected / exposed	0 / 1053 (0.00%)	1 / 1038 (0.10%)
occurrences all number	0	1
Respiratory tract infection bacterial
subjects affected / exposed	0 / 1053 (0.00%)	1 / 1038 (0.10%)
occurrences all number	0	1
Respiratory tract infection viral
subjects affected / exposed	1 / 1053 (0.09%)	2 / 1038 (0.19%)
occurrences all number	1	2
Staphylococcal bacteraemia
subjects affected / exposed	1 / 1053 (0.09%)	0 / 1038 (0.00%)
occurrences all number	1	0
Tonsillitis
subjects affected / exposed	1 / 1053 (0.09%)	0 / 1038 (0.00%)
occurrences all number	1	0
Upper respiratory tract infection
subjects affected / exposed	0 / 1053 (0.00%)	1 / 1038 (0.10%)
occurrences all number	0	1
Viral rhinitis
subjects affected / exposed	1 / 1053 (0.09%)	0 / 1038 (0.00%)
occurrences all number	1	0
Vulvovaginal candidiasis
subjects affected / exposed	0 / 1053 (0.00%)	1 / 1038 (0.10%)
occurrences all number	0	1
Viral sepsis
subjects affected / exposed	0 / 1053 (0.00%)	1 / 1038 (0.10%)
occurrences all number	0	1
Metabolism and nutrition disorders
Type 2 diabetes mellitus
subjects affected / exposed	4 / 1053 (0.38%)	1 / 1038 (0.10%)
occurrences all number	4	1
Lack of satiety
subjects affected / exposed	1 / 1053 (0.09%)	0 / 1038 (0.00%)
occurrences all number	1	0
Impaired fasting glucose
subjects affected / exposed	1 / 1053 (0.09%)	0 / 1038 (0.00%)
occurrences all number	1	0
Hypophosphataemia
subjects affected / exposed	1 / 1053 (0.09%)	1 / 1038 (0.10%)
occurrences all number	1	1
Hyponatraemia
subjects affected / exposed	0 / 1053 (0.00%)	2 / 1038 (0.19%)
occurrences all number	0	2
Hypomagnesaemia
subjects affected / exposed	1 / 1053 (0.09%)	0 / 1038 (0.00%)
occurrences all number	1	0
Hypokalaemia
subjects affected / exposed	3 / 1053 (0.28%)	3 / 1038 (0.29%)
occurrences all number	4	3
Hypervolaemia
subjects affected / exposed	1 / 1053 (0.09%)	0 / 1038 (0.00%)
occurrences all number	1	0
Hypertriglyceridaemia
subjects affected / exposed	1 / 1053 (0.09%)	0 / 1038 (0.00%)
occurrences all number	1	0
Hyperkalaemia
subjects affected / exposed	1 / 1053 (0.09%)	0 / 1038 (0.00%)
occurrences all number	1	0
Hyperglycaemia
subjects affected / exposed	4 / 1053 (0.38%)	2 / 1038 (0.19%)
occurrences all number	4	2
Gout
subjects affected / exposed	0 / 1053 (0.00%)	1 / 1038 (0.10%)
occurrences all number	0	1
Glucose tolerance impaired
subjects affected / exposed	0 / 1053 (0.00%)	1 / 1038 (0.10%)
occurrences all number	0	1
Diabetes mellitus inadequate control
subjects affected / exposed	1 / 1053 (0.09%)	2 / 1038 (0.19%)
occurrences all number	1	2
Diabetes mellitus
subjects affected / exposed	0 / 1053 (0.00%)	2 / 1038 (0.19%)
occurrences all number	0	2
Dehydration
subjects affected / exposed	1 / 1053 (0.09%)	2 / 1038 (0.19%)
occurrences all number	1	2
Decreased appetite
subjects affected / exposed	0 / 1053 (0.00%)	1 / 1038 (0.10%)
occurrences all number	0	1

More information

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Were there any global substantial amendments to the protocol? Yes

20 Nov 2021

To remove the second interim analysis (70% interim analysis that was added under Amendment 3) from the protocol because the objective of the planned 45% interim analysis was met.

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Percentage of Subjects With Covid-19 Related Hospitalisation or Death From any Cause Through Day 28- Modified Intent-To-Treat (mITT) Population

Primary: Percentage of Subjects With Covid-19 Related Hospitalisation or Death From any Cause Through Day 28- Modified Intent-To-Treat (mITT) Population

Secondary: Percentage of Subjects With Covid-19 Related Hospitalisation or Death From any Cause Through Day 28- Modified Intent-To-Treat 1 (mITT1) Population

Secondary: Percentage of Subjects With Covid-19 Related Hospitalisation or Death From any Cause Through Day 28- Modified Intent-To-Treat 1 (mITT1) Population

Secondary: Number of Subjects With AEs Leading to Discontinuation and Serious Adverse Events (SAEs)

Secondary: Number of Subjects With AEs Leading to Discontinuation and Serious Adverse Events (SAEs)

Secondary: Number of Subjects With Treatment Emergent Adverse Events (TEAEs)

Secondary: Number of Subjects With Treatment Emergent Adverse Events (TEAEs)

Secondary: Time to Sustained Alleviation of all Targeted COVID-19 Signs and Symptoms Through Day 28- mITT Population

Secondary: Time to Sustained Alleviation of all Targeted COVID-19 Signs and Symptoms Through Day 28- mITT Population

Secondary: Time to Sustained Alleviation of all Targeted COVID-19 Signs and Symptoms Through Day 28- mITT2 Population

Secondary: Time to Sustained Alleviation of all Targeted COVID-19 Signs and Symptoms Through Day 28- mITT2 Population

Secondary: Time to Sustained Alleviation of all Targeted COVID-19 Signs and Symptoms Through Day 28- mITT1 Population

Secondary: Time to Sustained Alleviation of all Targeted COVID-19 Signs and Symptoms Through Day 28- mITT1 Population

Secondary: Percentage of Subjects With Severe Covid-19 Signs and Symptoms Through Day 28- mITT2 Population

Secondary: Percentage of Subjects With Severe Covid-19 Signs and Symptoms Through Day 28- mITT2 Population

Secondary: Percentage of Subjects With Severe Covid-19 Signs and Symptoms Through Day 28- mITT1 Population

Secondary: Percentage of Subjects With Severe Covid-19 Signs and Symptoms Through Day 28- mITT1 Population

Secondary: Percentage of Subjects With Severe Covid-19 Signs and Symptoms Through Day 28- mITT Population

Secondary: Percentage of Subjects With Severe Covid-19 Signs and Symptoms Through Day 28- mITT Population

Secondary: Time to Sustained Resolution of all Targeted COVID-19 Signs and Symptoms Through Day 28- mITT Population

Secondary: Time to Sustained Resolution of all Targeted COVID-19 Signs and Symptoms Through Day 28- mITT Population

Secondary: Time to Sustained Resolution of all Targeted COVID-19 Signs and Symptoms Through Day 28- mITT2 Population

Secondary: Time to Sustained Resolution of all Targeted COVID-19 Signs and Symptoms Through Day 28- mITT2 Population

Secondary: Time to Sustained Resolution of all Targeted COVID-19 Signs and Symptoms Through Day 28- mITT1 Population

Secondary: Time to Sustained Resolution of all Targeted COVID-19 Signs and Symptoms Through Day 28- mITT1 Population

Secondary: Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT Population

Secondary: Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT Population

Secondary: Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population

Secondary: Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population

Secondary: Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population

Secondary: Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population

Secondary: Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT Population

Secondary: Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT Population

Secondary: Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population

Secondary: Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population

Secondary: Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population

Secondary: Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population

Secondary: Number of Subjects With Progression to a Worsening Status in 1 or More Self-reported COVID-19 Associated Symptoms Through Day 28-mITT Population

Secondary: Number of Subjects With Progression to a Worsening Status in 1 or More Self-reported COVID-19 Associated Symptoms Through Day 28-mITT Population

Secondary: Number of Subjects With Progression to a Worsening Status in 1 or More Self-reported COVID-19 Associated Symptoms Through Day 28-mITT1 Population

Secondary: Number of Subjects With Progression to a Worsening Status in 1 or More Self-reported COVID-19 Associated Symptoms Through Day 28-mITT1 Population

Secondary: Number of Subjects With Progression to a Worsening Status in 1 or More Self-reported COVID-19 Associated Symptoms Through Day 28-mITT2 Population

Secondary: Number of Subjects With Progression to a Worsening Status in 1 or More Self-reported COVID-19 Associated Symptoms Through Day 28-mITT2 Population

Secondary: Percentage of Subjects With a Resting Peripheral Oxygen Saturation >=95% at Days 1 and 5- mITT1 Population

Secondary: Percentage of Subjects With a Resting Peripheral Oxygen Saturation >=95% at Days 1 and 5- mITT1 Population

Secondary: Percentage of Subjects With a Resting Peripheral Oxygen Saturation >=95% at Days 1 and 5- mITT Population

Secondary: Percentage of Subjects With a Resting Peripheral Oxygen Saturation >=95% at Days 1 and 5- mITT Population

Secondary: Percentage of Subjects Who Died Through Week 24- mITT Population

Secondary: Percentage of Subjects Who Died Through Week 24- mITT Population

Secondary: Percentage of Subjects With a Resting Peripheral Oxygen Saturation >=95% at Days 1 and 5- mITT2 Population

Secondary: Percentage of Subjects With a Resting Peripheral Oxygen Saturation >=95% at Days 1 and 5- mITT2 Population

Secondary: Percentage of Subjects Who Died Through Week 24- mITT1 Population

Secondary: Percentage of Subjects Who Died Through Week 24- mITT1 Population

Secondary: Change From Baseline in Logarithm to Base10 (Log10) Transformed Viral Load at Day 3, 5, 10 and 14- mITT Population

Secondary: Change From Baseline in Logarithm to Base10 (Log10) Transformed Viral Load at Day 3, 5, 10 and 14- mITT Population

Secondary: Plasma Concentration Versus Time Summary of PF-07321332

Secondary: Plasma Concentration Versus Time Summary of PF-07321332

Secondary: Percentage of Subjects Who Died Through Week 24- mITT2 Population

Secondary: Percentage of Subjects Who Died Through Week 24- mITT2 Population

Secondary: Change From Baseline in Log10 Transformed Viral Load at Day 3, 5, 10 and 14- mITT2 Population

Secondary: Change From Baseline in Log10 Transformed Viral Load at Day 3, 5, 10 and 14- mITT2 Population

Secondary: Change From Baseline in Log10 Transformed Viral Load at Day 3, 5, 10 and 14- mITT1 Population

Secondary: Change From Baseline in Log10 Transformed Viral Load at Day 3, 5, 10 and 14- mITT1 Population

Secondary: Number of COVID-19 Related Medical Visits- mITT2 Population

Secondary: Number of COVID-19 Related Medical Visits- mITT2 Population

Secondary: Number of Days in Hospital and ICU for the Treatment of COVID-19- mITT Population

Secondary: Number of Days in Hospital and ICU for the Treatment of COVID-19- mITT Population

Secondary: Number of COVID-19 Related Medical Visits- mITT Population

Secondary: Number of COVID-19 Related Medical Visits- mITT Population

Secondary: Number of COVID-19 Related Medical Visits- mITT1 Population