A Study of a Potential Oral Treatment to Prevent COVID-19... | NCT05047601

ID	Type	Description	Link
2021-002894-24	EudraCT Number
EPIC-PEP	Other Identifier	Alias Study Number

A Study of a Potential Oral Treatment to Prevent COVID-19... | NCT05047601 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PF-07321332/ritonavir (5 days)	Experimental	Participants will receive PF-07321332/ritonavir every 12 hours from Day 1 through Day 5 followed by Placebo every 12 hours from Day 6 through Day 10	Drug: PF-07321332 Drug: Placebo for PF-07321332 Drug: Placebo for Ritonavir Drug: Ritonavir
PF-07321332/ritonavir (10-Day)	Experimental	Participants will receive PF-07321332/ritonavir every 12 hours from Day 1 through Day 10.	Drug: PF-07321332 Drug: Ritonavir
Placebo	Placebo Comparator	Participants will receive placebo every 12 hours from Day 1 through Day 10.	Drug: Placebo for PF-07321332 Drug: Placebo for Ritonavir

Name	Type	Description	Arm Group Labels	Other Names
PF-07321332	Drug	PF-07321332	PF-07321332/ritonavir (10-Day) PF-07321332/ritonavir (5 days)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants Who Developed Symptomatic RT-PCR or RAT Confirmed SARS-CoV-2 Infection Through Day 14: Among Participants With Negative RT-PCR at Baseline	Percentage of participants who developed symptomatic Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) or Rapid Antigen Test (RAT) confirmed SARS-Cov-2 infection were reported in this outcome measure. Index case was defined as participants with symptomatic COVID-19.	From Day 1 to Day 14

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious AEs and AEs Leading to Study and Study Drug Discontinuation	An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening ; required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity ; congenital anomaly/birth defect; or that was considered as an important medical event. TEAEs were defined as events that started on or after the study medication start date and time. AEs included both serious and all non-serious adverse events. AEs that led to study discontinuation and AEs that led to discontinuation of study intervention and then continued study were also reported in this outcome measure.

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Cahaba Research Inc		Pelham	Alabama	35124	United States
The Institute for Liver Health dba Arizona Clinical Trials

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39018532	Derived	Hammond J, Yunis C, Fountaine RJ, Luscan G, Burr AM, Zhang W, Wisemandle W, Soares H, Baniecki ML, Hendrick VM, Kalfov V, Pypstra R, Rusnak JM. Oral Nirmatrelvir-Ritonavir as Postexposure Prophylaxis for Covid-19. N Engl J Med. 2024 Jul 18;391(3):224-234. doi: 10.1056/NEJMoa2309002.

Label	URL
To obtain contact information for a study center near you, click here.	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days	Participants were randomized to receive nirmatrelvir 300 milligrams (mg) and ritonavir 100 mg orally every 12 hours from Day 1 to 5, followed by matching placebo every 12 hours from Day 6 through Day 10.
FG001	Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jan 25, 2022	Apr 11, 2023

Type	Comment	Reasons
Lost to Follow-up		FG0009 subjects FG00111 subjects FG0027 subjects
Withdrawal by Subject		FG00025 subjects FG00136 subjects FG00223 subjects
Other		FG00010 subjects FG0016 subjects FG0025 subjects

Arm/Group Information

ID	Title	Description
BG000	Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days	Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 5, followed by matching placebo every 12 hours from Day 6 through Day 10.
BG001	Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days	Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 10.
BG002	Placebo	Participants were randomized to receive placebo matched to nirmatrelvir/ritonavir every 12 hours for 10 days from Day 1 through Day 10.
BG003	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	BG00043.92± 14.88 BG00142.85± 15.02 BG00242.39± 14.36 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000502 BG001479 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG000664 BG001642 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG00058 BG00152 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participants Who Developed Symptomatic RT-PCR or RAT Confirmed SARS-CoV-2 Infection Through Day 14: Among Participants With Negative RT-PCR at Baseline

Percentage of participants who developed symptomatic Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) or Rapid Antigen Test (RAT) confirmed SARS-Cov-2 infection were reported in this outcome measure. Index case was defined as participants with symptomatic COVID-19.

Modified Intent-To-Treat (mITT) population included all participants randomly assigned to study intervention who received at least 1 dose of study intervention and had a negative RT-PCR result at baseline.

Posted

Number

Percentage of participants

From Day 1 to Day 14

ID	Title	Description
OG000	Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days	Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 5, followed by matching placebo every 12 hours from Day 6 through Day 10.
OG001	Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days	Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 10.
OG002	Placebo	Participants were randomized to receive placebo matched to nirmatrelvir/ritonavir every 12 hours for 10 days from Day 1 through Day 10.

Units	Counts
Participants	OG000844 OG001830 OG002840

Title

Denominators

Categories

Title	Measurements
	OG0002.607 OG0012.410 OG0023.929

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG002		Generalized estimating equation (GEE)	Model included the fixed effects of treatment, geographic regions and presence of risk factors. Compound symmetry variance-covariance structure.	0.1722		Risk Ratio (RR)	0.702			2-Sided	95	0.422	1.167					Superiority
OG001 OG002

Secondary

Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious AEs and AEs Leading to Study and Study Drug Discontinuation

An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening ; required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity ; congenital anomaly/birth defect; or that was considered as an important medical event. TEAEs were defined as events that started on or after the study medication start date and time. AEs included both serious and all non-serious adverse events. AEs that led to study discontinuation and AEs that led to discontinuation of study intervention and then continued study were also reported in this outcome measure.

Safety analysis set included all participants randomly assigned to study intervention and who received at least 1 dose of study intervention.

Posted

Count of Participants

Participants

From start of study intervention (Day 1) up to end of safety follow-up (Day 38)

ID	Title	Description
OG000	Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days	Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 5, followed by matching placebo every 12 hours from Day 6 through Day 10.
OG001

Secondary

Percentage of Participants Who Developed Symptomatic RT-PCR or RAT Confirmed SARS-CoV-2 Infection Through Day 14: Among Participants With Negative RT-PCR at Baseline With Increased Risk of Severe COVID-19 Illness

Percentage of participants who had a symptomatic RT-PCR or RAT confirmed SARS-Cov-2 infection were reported in this outcome measure. The risk factors associated with severe covid-19 illness included age greater than or equal to 60 years, body mass index greater than 25, social history of smoking and presence of comorbidities. Index case was defined as participants with symptomatic COVID-19.

Modified Intent-To-Treat (mITT2) population included all participants randomly assigned to study intervention who received at least 1 dose of study intervention and had a negative RT-PCR result at baseline and were at increased risk of severe COVID-19 illness.

Posted

Number

Percentage of participants

From Day 1 to Day 14

ID	Title	Description
OG000	Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days	Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 5, followed by matching placebo every 12 hours from Day 6 through Day 10.
OG001	Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days	Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 10.

Secondary

Percentage of Participants With COVID-19 Related Hospitalization or Death From Any Cause Through Day 28: Among Participants With Negative RT-PCR at Baseline With Increased Risk of Severe COVID-19 Illness

The risk factors associated with severe covid-19 illness included age greater than or equal to 60 years, body mass index greater than 25, social history of smoking and presence of comorbidities.

mITT2 population included all participants randomly assigned to study intervention who received at least 1 dose of study intervention and had a negative RT-PCR result at baseline and were at increased risk of severe COVID-19 illness.

Posted

Number

Percentage of participants

From Day 1 to Day 28

ID	Title	Description
OG000	Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days	Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 5, followed by matching placebo every 12 hours from Day 6 through Day 10.
OG001	Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days	Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 10.
OG002	Placebo	Participants were randomized to receive placebo matched to nirmatrelvir/ritonavir every 12 hours for 10 days from Day 1 through Day 10.

Secondary

Percentage of Participants With Asymptomatic RT-PCR or RAT Confirmed SARS-CoV-2 Infection Through Day 14: Among Participants With Negative RT-PCR at Baseline

Percentage of participants who had asymptomatic RT-PCR or RAT confirmed SARS-CoV-2 infection through day 14 among participants with negative RT-PCR at baseline were reported in this outcome measure. Index case was defined as participants with symptomatic COVID-19.

mITT population included all participants randomly assigned to study intervention who received at least 1 dose of study intervention and had a negative RT-PCR result at baseline.

Posted

Number

Percentage of participants

From Day 1 to Day 14

ID	Title	Description
OG000	Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days	Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 5, followed by matching placebo every 12 hours from Day 6 through Day 10.
OG001	Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days	Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 10.
OG002	Placebo	Participants were randomized to receive placebo matched to nirmatrelvir/ritonavir every 12 hours for 10 days from Day 1 through Day 10.

Secondary

Time to RT-PCR or RAT Confirmed SARS-CoV-2 Infection Through Day 14: Among Participants With Negative RT-PCR at Baseline

Number of days between first dose and confirmation of the SARS-CoV-2 infection by RT-PCR or RAT was reported in this outcome measure.

mITT population included all participants randomly assigned to study intervention who received at least 1 dose of study intervention and had a negative RT-PCR result at baseline.

Posted

Median

95% Confidence Interval

Days

From Day 1 to Day 14

ID	Title	Description
OG000	Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days	Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 5, followed by matching placebo every 12 hours from Day 6 through Day 10.
OG001	Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days	Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 10.
OG002	Placebo	Participants were randomized to receive placebo matched to nirmatrelvir/ritonavir every 12 hours for 10 days from Day 1 through Day 10.

Secondary

Percentage of Participants With Symptomatic RT-PCR or RAT Confirmed SARS-CoV-2 Infection Through Day 14: Among Participants With Positive RT-PCR at Baseline

Percentage of participants with a positive RT-PCR result at baseline who had a symptomatic SARS-CoV-2 infection confirmed by RAT or RT-PCR through Day 14 were reported in this outcome measure. Index case was defined as participants with symptomatic COVID-19.

mITT1 population included all participants randomly assigned to study intervention who received at least 1 dose of study intervention and had a positive RT-PCR result at baseline.

Posted

Number

Percentage of participants

From Day 1 to Day 14

ID	Title	Description
OG000	Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days	Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 5, followed by matching placebo every 12 hours from Day 6 through Day 10.
OG001	Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days	Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 10.
OG002	Placebo	Participants were randomized to receive placebo matched to nirmatrelvir/ritonavir every 12 hours for 10 days from Day 1 through Day 10.

Secondary

Percentage of Participants With Symptomatic RT-PCR or RAT Confirmed SARS-CoV-2 Infection Through Day 14: Among Participants With Negative, Positive or Missing RT-PCR at Baseline

Percentage of participants with a negative, positive, or missing RT-PCR result at baseline, who had a symptomatic SARS-CoV-2 infection confirmed by RAT or RT-PCR through Day 14 were reported in this outcome measure. Index case was defined as participants with symptomatic COVID-19.

Modified Intent-To-Treat (mITT3) population included all participants randomly assigned to study intervention who received at least 1 dose of study intervention and had a negative, positive or missing RT-PCR result at baseline.

Posted

Number

Percentage of Participants

From Day 1 to Day 14

ID	Title	Description
OG000	Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days	Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 5, followed by matching placebo every 12 hours from Day 6 through Day 10.
OG001	Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days	Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 10.
OG002	Placebo

Secondary

Percentage of Participants With no, Mild, Moderate, or Severe Signs and Symptoms Attributed to COVID-19 Through Day 28: Among Participants With Negative RT-PCR at Baseline

Participants were categorized according to severity of signs and symptoms as no, mild, moderate, severe in this outcome measure. The 12 signs and symptoms included stuffy or runny nose, sore throat, shortness of breath or difficulty breathing, cough, low energy or tiredness, muscle or body aches, headache, chills or shivering, feeling hot or feverish, nausea, vomiting, diarrhea. Participants recorded their daily severity rating of their symptoms over the past 24 hours based on a 4-point scale in which 0 was reported if no symptoms were present; 1 if mild; 2 if moderate; and 3 if severe.

mITT population included all participants randomly assigned to study intervention who received at least 1 dose of study intervention and had a negative RT-PCR result at baseline.

Posted

Number

Percentage of participants

From Day 1 to Day 28

ID	Title	Description
OG000	Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days	Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 5, followed by matching placebo every 12 hours from Day 6 through Day 10.
OG001	Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days	Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 10.

Secondary

Number of Days of Symptomatic RT-PCR or RAT Confirmed SARS-CoV- 2 Infection Through Day 28: Among Participants With Negative RT-PCR at Baseline

This outcome measure has been reported in terms of number of participants according to days of symptomatic SARS-CoV-2 infection through Day 28.

mITT population included all participants randomly assigned to study intervention who received at least 1 dose of study intervention and had a negative RT-PCR result at baseline. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.

Posted

Count of Participants

Participants

From Day 1 to Day 28

ID	Title	Description
OG000	Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days	Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 5, followed by matching placebo every 12 hours from Day 6 through Day 10.
OG001	Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days	Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 10.
OG002	Placebo	Participants were randomized to receive placebo matched to nirmatrelvir/ritonavir every 12 hours for 10 days from Day 1 through Day 10.

Secondary

Plasma Concentration Versus Time Summary of Nirmatrelvir (PF-07321332)

Safety analysis set included all participants randomly assigned to study intervention and who received at least 1 dose of study intervention. This outcome measure was not planned to be analyzed for placebo arm. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure and ''Number Analyzed'' signifies participants evaluable at specific time points.

Posted

Mean

Standard Deviation

Nanograms per milliliter

Day 1: 1 hour post dose; Day 5: 2 hours pre-dose

ID	Title	Description
OG000	Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days	Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 5, followed by matching placebo every 12 hours from Day 6 through Day 10.
OG001	Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days	Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 10.

Units	Counts
Participants

Secondary

Percentage of Participants With Death Event Through Day 38: Among Participants With Negative RT-PCR at Baseline

Percentage of participants with death (all-cause) event were reported in this outcome measure.

mITT population included all participants randomly assigned to study intervention who received at least 1 dose of study intervention and had a negative RT-PCR result at baseline.

Posted

Number

Percentage of participants

From Day 1 to Day 38

ID	Title	Description
OG000	Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days	Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 5, followed by matching placebo every 12 hours from Day 6 through Day 10.
OG001	Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days	Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 10.
OG002	Placebo	Participants were randomized to receive placebo matched to nirmatrelvir/ritonavir every 12 hours for 10 days from Day 1 through Day 10.

Secondary

Viral Load in Nasal Samples Over Time: Among Participants With Negative RT-PCR at Baseline

Nasal samples were collected to estimate the viral load in terms of logarithm to base 10 (log10) copies per milliliter in participants with negative RT-PCR at baseline and were reported in this outcome measure.

mITT population included all participants randomly assigned to study intervention who received at least 1 dose of study intervention and had a negative RT-PCR result at baseline. Here 'Number Analyzed' signifies participants evaluable for the specific time points.

Posted

Mean

Standard Deviation

Log 10 copies per milliliter

From Day 1 to Day 14

ID	Title	Description
OG000	Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days	Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 5, followed by matching placebo every 12 hours from Day 6 through Day 10.
OG001	Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days	Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 10.
OG002	Placebo	Participants were randomized to receive placebo matched to nirmatrelvir/ritonavir every 12 hours for 10 days from Day 1 through Day 10.

Secondary

Viral Load in Nasal Samples Over Time: Among Participants With Positive RT-PCR at Baseline

Nasal samples were collected to estimate the viral load in terms of logarithm to base 10 (log10) copies per milliliter in participants with positive RT-PCR at baseline and were reported in this outcome measure.

mITT1 population included all participants randomly assigned to study intervention who received at least 1 dose of study intervention and had a positive RT-PCR result at baseline. Here 'Number Analyzed' signifies participants evaluable for the specific time points.

Posted

Mean

Standard Deviation

Log 10 copies per milliliter

From Day 1 to Day 14

ID	Title	Description
OG000	Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days	Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 5, followed by matching placebo every 12 hours from Day 6 through Day 10.
OG001	Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days	Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 10.
OG002	Placebo	Participants were randomized to receive placebo matched to nirmatrelvir/ritonavir every 12 hours for 10 days from Day 1 through Day 10.

Secondary

Number of Days of Hospitalization and Intensive Care Unit (ICU) Stay: Among Participants With Negative RT-PCR at Baseline

This outcome measure has been presented in terms of participants according to number of days of hospitalization and in ICU as 0 days and more than or equal to 1 day.

mITT population included all participants randomly assigned to study intervention who received at least 1 dose of study intervention and had a negative RT-PCR result at baseline.

Posted

Count of Participants

Participants

From Day 1 to Day 28

ID	Title	Description
OG000	Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days	Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 5, followed by matching placebo every 12 hours from Day 6 through Day 10.
OG001	Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days	Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 10.
OG002	Placebo	Participants were randomized to receive placebo matched to nirmatrelvir/ritonavir every 12 hours for 10 days from Day 1 through Day 10.

Secondary

Number of COVID-19 Related Medical Visits Through Day 28: Among Participants With Negative RT-PCR at Baseline

In this outcome measure number of COVID-19 related medical visits per day were reported. Number of medical visits per day = number of medical visits/number of days follow up through day 28 visit or the last collection date on or before day 28, if day 28 visit was missing.

mITT population included all participants randomly assigned to study intervention who received at least 1 dose of study intervention and had a negative RT-PCR result at baseline.

Posted

Mean

Standard Deviation

Medical visits per day

From Day 1 to Day 28

ID	Title	Description
OG000	Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days	Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 5, followed by matching placebo every 12 hours from Day 6 through Day 10.
OG001	Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days	Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 10.
OG002	Placebo	Participants were randomized to receive placebo matched to nirmatrelvir/ritonavir every 12 hours for 10 days from Day 1 through Day 10.

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days	Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 5, followed by matching placebo every 12 hours from Day 6 through Day 10.	912	3	912	176	912
EG001	Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days	Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 10.	911	1	911	173	911
EG002	Placebo	Participants were randomized to receive placebo matched to nirmatrelvir/ritonavir every 12 hours for 10 days from Day 1 through Day 10.	898	2	898	152	898

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Cholecystitis acute	Hepatobiliary disorders	MedDRA v24.1	Non-systematic Assessment	EG0001 affected912 at risk EG0010 affected911 at risk EG0020 affected898 at risk
COVID-19 pneumonia	Infections and infestations	MedDRA v24.1	Non-systematic Assessment	EG0001 affected912 at risk EG0011 affected911 at risk EG0021 affected898 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA v24.1	Non-systematic Assessment	EG0000 affected912 at risk EG0010 affected911 at risk EG0021 affected898 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA v24.1	Non-systematic Assessment	EG0001 affected912 at risk EG0010 affected911 at risk EG0020 affected898 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA v24.1	Non-systematic Assessment	EG0001 affected912 at risk EG0010 affected911 at risk EG0020 affected898 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA v24.1	Non-systematic Assessment	EG00023 affected912 at risk EG00122 affected911 at risk EG00215 affected898 at risk
Nausea	Gastrointestinal disorders	MedDRA v24.1	Non-systematic Assessment	EG00016 affected912 at risk EG00112 affected911 at risk EG00214 affected898 at risk
Asthenia	General disorders	MedDRA v24.1	Non-systematic Assessment	EG00010 affected912 at risk EG0017 affected911 at risk EG00217 affected898 at risk
COVID-19	Infections and infestations	MedDRA v24.1	Non-systematic Assessment	EG00027 affected912 at risk EG00126 affected911 at risk EG00236 affected898 at risk
Nasopharyngitis	Infections and infestations	MedDRA v24.1	Non-systematic Assessment	EG00013 affected912 at risk EG0019 affected911 at risk EG0026 affected898 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA v24.1	Non-systematic Assessment	EG00020 affected912 at risk EG00117 affected911 at risk EG00218 affected898 at risk
Activated partial thromboplastin time prolonged	Investigations	MedDRA v24.1	Non-systematic Assessment	EG00011 affected912 at risk EG00114 affected911 at risk EG00222 affected898 at risk
Alanine aminotransferase increased	Investigations	MedDRA v24.1	Non-systematic Assessment	EG0002 affected912 at risk EG0016 affected911 at risk EG00211 affected898 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA v24.1	Non-systematic Assessment	EG00012 affected912 at risk EG00115 affected911 at risk EG00213 affected898 at risk
Blood thyroid stimulating hormone increased	Investigations	MedDRA v24.1	Non-systematic Assessment	EG00011 affected912 at risk EG0018 affected911 at risk EG00210 affected898 at risk
Fibrin D dimer increased	Investigations	MedDRA v24.1	Non-systematic Assessment	EG00018 affected912 at risk EG00113 affected911 at risk EG0024 affected898 at risk
Dysgeusia	Nervous system disorders	MedDRA v24.1	Non-systematic Assessment	EG00054 affected912 at risk EG00162 affected911 at risk EG0026 affected898 at risk
Headache	Nervous system disorders	MedDRA v24.1	Non-systematic Assessment	EG00015 affected912 at risk EG00117 affected911 at risk EG00229 affected898 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA v24.1	Non-systematic Assessment	EG00010 affected912 at risk EG0012 affected911 at risk EG00212 affected898 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA v24.1	Non-systematic Assessment	EG0004 affected912 at risk EG0013 affected911 at risk EG00210 affected898 at risk

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections
D014777	Virus Diseases
D018352	Coronavirus Infections
D003333	Coronaviridae Infections
D030341	Nidovirales Infections
D012327	RNA Virus Infections
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

Title

Denominators

Categories

TEAEs

Title	Measurements
	OG000218 OG001212 OG002195

SAEs

Title	Measurements
	OG0003 OG0011 OG0022

AEs led to discontinuation of study

Title	Measurements
	OG0000 OG0010 OG0020

AEs led to discontinue study intervention and continued study

Title	Measurements
	OG00010 OG00111 OG00214

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG002		GEE	Model included the fixed effects of treatment, geographic regions. Compound symmetry variance-covariance structure.	0.6766		Risk Ratio (RR)	0.880			2-Sided	95	0.484	1.602					Superiority
OG001 OG002		GEE	Model included the fixed effects of treatment, geographic regions. Compound symmetry variance-covariance structure.	0.5070		Risk Ratio (RR)	0.809			2-Sided	95	0.433	1.512					Superiority

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG002		GEE	Model included the fixed effects of treatment, geographic regions and presence of risk factors. Compound symmetry variance-covariance structure.	0.1869		Risk Ratio (RR)	0.672			2-Sided	95	0.373	1.213					Superiority
OG001 OG002		GEE	Model included the fixed effects of treatment, geographic regions and presence of risk factors. Compound symmetry variance-covariance structure.	0.1221		Risk Ratio (RR)	0.633			2-Sided	95	0.355	1.130					Superiority

Title

Denominators

Categories

Title

Measurements

OG000NA(NA to NA)Median and the corresponding 95% CI could not be calculated as the proportion of participants who achieved the event were low.
OG001NA(NA to NA)Median and the corresponding 95% CI could not be calculated as the proportion of participants who achieved the event were low.
OG002NA(NA to NA)Median and the corresponding 95% CI could not be calculated as the proportion of participants who achieved the event were low.

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG002		Log Rank		0.0368														Superiority
OG001 OG002		Log Rank		0.0186														Superiority

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG002		GEE	Model included the fixed effects of treatment, geographic regions and presence of risk factors. Compound symmetry variance-covariance structure.	0.4126		Risk Ratio (RR)	0.750			2-Sided	95	0.378	1.491					Superiority
OG001 OG002		GEE	Model included the fixed effects of treatment, geographic regions and presence of risk factors. Compound symmetry variance-covariance structure.	0.4273		Risk Ratio (RR)	1.244			2-Sided	95	0.725	2.135					Superiority

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG002		GEE	Model included the fixed effects of treatment, geographic regions and presence of risk factors. Compound symmetry variance-covariance structure.	0.1333		Risk Ratio (RR)	0.726			2-Sided	95	0.478	1.103					Superiority
OG001 OG002		GEE	Model included the fixed effects of treatment, geographic regions and presence of risk factors. Compound symmetry variance-covariance structure.	0.8088		Risk Ratio (RR)	0.953			2-Sided	95	0.645	1.408					Superiority

Title

Denominators

Categories

Title	Measurements
	OG00081.517 OG00183.373 OG00281.667

Mild

Title	Measurements
	OG0007.820 OG0018.193 OG0027.619

Moderate

Title	Measurements
	OG0006.872 OG0015.060 OG0027.143

Severe

Title	Measurements
	OG0002.133 OG0012.048 OG0022.738

Missing

Title	Measurements
	OG0001.659 OG0011.325 OG0020.833

Title

Denominators

Categories

Title	Measurements
1 Day of Symptoms	OG0001 OG0017 OG0022
2 Days of Symptoms	OG0002 OG0010 OG0021
3 Days of Symptoms	OG0000 OG0011 OG0024
4 Days of Symptoms	OG0005 OG0010 OG0022
5 Days of Symptoms	OG0001 OG0013 OG0023
6 Days of Symptoms	OG0000 OG0011 OG0023
7 Days of Symptoms	OG0003 OG0014 OG0024
8 Days of Symptoms	OG0002 OG0010 OG0025
9 Days of Symptoms	OG0000 OG0011 OG0021
10 Days of Symptoms	OG0000 OG0010 OG0021
11 Days of Symptoms	OG0000 OG0011 OG0021
12 Days of Symptoms	OG0002 OG0010 OG0024
13 Days of Symptoms	OG0001 OG0011 OG0022
14 Days of Symptoms	OG0001 OG0011 OG0020
18 Days of Symptoms	OG0002 OG0010 OG0020
20 Days of Symptoms	OG0001 OG0010 OG0020
26 Days of Symptoms	OG0001 OG0010 OG0020

Title

Denominators

Categories

Day 1 (1 hour post-dose)

- ParticipantsOG000159
- ParticipantsOG001156

Title	Measurements
	OG0001489± 1481.4 OG0011472± 1488.2

Day 5 (2 hours pre-dose)

- ParticipantsOG000476
- ParticipantsOG001476

Title	Measurements
	OG0001688± 2093.3 OG001

Title

Denominators

Categories

Day 1

- ParticipantsOG000844
- ParticipantsOG001830
- ParticipantsOG002840

Title	Measurements
	OG0000.042± 0.265 OG0010.035± 0.241 OG0020.038± 0.253

Day 2

- ParticipantsOG000810
- ParticipantsOG001802
- ParticipantsOG002809

Title	Measurements
	OG000

Day 3

- ParticipantsOG000823
- ParticipantsOG001812
- ParticipantsOG002812

Title	Measurements
	OG000

Day 4

- ParticipantsOG000820
- ParticipantsOG001808
- ParticipantsOG002813

Title	Measurements
	OG000

Day 5

- ParticipantsOG000736
- ParticipantsOG001737
- ParticipantsOG002742

Title	Measurements
	OG000

Day 6

- ParticipantsOG000817
- ParticipantsOG001799
- ParticipantsOG002812

Title	Measurements
	OG000

Day 7

- ParticipantsOG000815
- ParticipantsOG001798
- ParticipantsOG002806

Title	Measurements
	OG000

Day 8

- ParticipantsOG000814
- ParticipantsOG001796
- ParticipantsOG002805

Title	Measurements
	OG000

Day 9

- ParticipantsOG000810
- ParticipantsOG001795
- ParticipantsOG002807

Title	Measurements
	OG000

Day 10

- ParticipantsOG000733
- ParticipantsOG001715
- ParticipantsOG002714

Title	Measurements
	OG000

Day 11

- ParticipantsOG000797
- ParticipantsOG001789
- ParticipantsOG002793

Title	Measurements
	OG000

Day 12

- ParticipantsOG000803
- ParticipantsOG001783
- ParticipantsOG002798

Title	Measurements
	OG000

Day 13

- ParticipantsOG000797
- ParticipantsOG001791
- ParticipantsOG002794

Title	Measurements
	OG000

Day 14

- ParticipantsOG000696
- ParticipantsOG001670
- ParticipantsOG002686

Title	Measurements
	OG000

Title

Denominators

Categories

Day 1

- ParticipantsOG00038
- ParticipantsOG00148
- ParticipantsOG00229

Title	Measurements
	OG0004.870± 2.041 OG0014.470± 1.542 OG0024.837± 1.577

Day 2

- ParticipantsOG00038
- ParticipantsOG00145
- ParticipantsOG00228

Title	Measurements
	OG000

Day 3

- ParticipantsOG00038
- ParticipantsOG00146
- ParticipantsOG00228

Title	Measurements
	OG000

Day 4

- ParticipantsOG00036
- ParticipantsOG00147
- ParticipantsOG00228

Title	Measurements
	OG000

Day 5

- ParticipantsOG00035
- ParticipantsOG00143
- ParticipantsOG00227

Title	Measurements
	OG000

Day 6

- ParticipantsOG00038
- ParticipantsOG00144
- ParticipantsOG00228

Title	Measurements
	OG000

Day 7

- ParticipantsOG00037
- ParticipantsOG00145
- ParticipantsOG00228

Title	Measurements
	OG000

Day 8

- ParticipantsOG00037
- ParticipantsOG00145
- ParticipantsOG00228

Title	Measurements
	OG000

Day 9

- ParticipantsOG00038
- ParticipantsOG00144
- ParticipantsOG00228

Title	Measurements
	OG000

Day 10

- ParticipantsOG00035
- ParticipantsOG00145
- ParticipantsOG00228

Title	Measurements
	OG000

Day 11

- ParticipantsOG00036
- ParticipantsOG00144
- ParticipantsOG00228

Title	Measurements
	OG000

Day 12

- ParticipantsOG00037
- ParticipantsOG00144
- ParticipantsOG00228

Title	Measurements
	OG000

Day 13

- ParticipantsOG00036
- ParticipantsOG00145
- ParticipantsOG00226

Title	Measurements
	OG000

Day 14

- ParticipantsOG00031
- ParticipantsOG00140
- ParticipantsOG00225

Title	Measurements
	OG000

Title

Denominators

Categories

ICU Visits: 0 Day

Title	Measurements
	OG000844 OG001830 OG002840

ICU Visits: More than or equal to 1 day

Title	Measurements
	OG0000 OG0010 OG0020

Hospitalization Visits: 0 Day

Title	Measurements
	OG000844 OG001830 OG002839

Hospitalization Visits: More than or equal to 1 day

Title	Measurements
	OG0000 OG0010 OG0021

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG002		Negative binomial regression model		0.7991		LS Mean Ratio	0.969			2-Sided	95	0.758	1.238					Superiority
OG001 OG002		Negative binomial regression model		0.1985		LS Mean Ratio	0.847			2-Sided	95	0.657	1.091					Superiority

ID	Term
D013844	Thiazoles
D013457	Sulfur Compounds
D009930	Organic Chemicals
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds