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    Clinical Trial Results:
    A Phase 2/3, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled Study to Evaluate the Safety and Efficacy of 2 Regimens of Orally Administered PF-07321332/Ritonavir in Preventing Symptomatic SARS-CoV-2 Infection in Adult Household Contacts of an Individual With Symptomatic COVID-19

    Summary
    EudraCT number
    		 2021-002894-24
    Trial protocol
    		 ES   BG   HU  
    Global end of trial date
    12 Apr 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Apr 2023
    First version publication date
    27 Apr 2023
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    C4671006
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05047601
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Pfizer Inc.
    Sponsor organisation address
    235 E 42nd 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 18007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    27 May 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Apr 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the efficacy of 5-day and 10-day regimens of PF-07321332/ritonavir versus placebo in preventing symptomatic Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) or Rapid Antigen Test (RAT)-confirmed SARS-CoV-2 infection in adult subjects who have a negative RT-PCR result at baseline and who are household contacts of an individual with symptomatic COVID-19.
    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 Council for Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trials subjects were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    09 Sep 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 6
    Country: Number of subjects enrolled
    Brazil: 3
    Country: Number of subjects enrolled
    Bulgaria: 229
    Country: Number of subjects enrolled
    Colombia: 3
    Country: Number of subjects enrolled
    Czechia: 3
    Country: Number of subjects enrolled
    Hungary: 2
    Country: Number of subjects enrolled
    Japan: 10
    Country: Number of subjects enrolled
    Malaysia: 2
    Country: Number of subjects enrolled
    Mexico: 195
    Country: Number of subjects enrolled
    Poland: 2
    Country: Number of subjects enrolled
    Russian Federation: 127
    Country: Number of subjects enrolled
    South Africa: 140
    Country: Number of subjects enrolled
    Spain: 1
    Country: Number of subjects enrolled
    Thailand: 4
    Country: Number of subjects enrolled
    Turkey: 8
    Country: Number of subjects enrolled
    Ukraine: 99
    Country: Number of subjects enrolled
    United States: 1902
    Worldwide total number of subjects
    2736
    EEA total number of subjects
    237
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    2508
    From 65 to 84 years
    221
    85 years and over
    7

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects who had a negative screening severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) rapid antigen test result and were asymptomatic household contacts of individuals who were symptomatic and recently tested positive for SARS-CoV-2, were included in the study.

    Pre-assignment
    Screening details
    		 A total of 2880 subjects were screened. Out of which, 122 subjects were screen failures. 22 subjects were not screen failures and were not randomised. 2736 subjects were randomised and 2721 subjects received study drug.

    Period 1
    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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days
    Arm description
    		 Subjects were randomised 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.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nirmatrelvir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Nirmatrelvir 300 mg every 12 hours

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet, Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo every 12 hours

    Investigational medicinal product name
    Ritonavir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Ritonavir 100 mg every 12 hours

    Arm title
    		 Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days
    Arm description
    		 Subjects were randomised to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 10.
    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
    Ritonavir 100 mg every 12 hours

    Investigational medicinal product name
    Nirmatrelvir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Nirmatrelvir 300 mg every 12 hours

    Arm title
    		 Placebo
    Arm description
    		 Subjects were randomised to receive placebo matched to nirmatrelvir/ritonavir every 12 hours for 10 days from Day 1 through Day 10.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet, Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo every 12 hours

    Number of subjects in period 1
    		Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days Placebo
    Started
    921
    917
    898
    Treated
    913
    911
    897
    Completed
    877
    864
    863
    Not completed
    44
    53
    35
         Consent withdrawn by subject
    25
    36
    23
         Unspecified
    10
    6
    5
         Lost to follow-up
    9
    11
    7

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days
    Reporting group description
    		 Subjects were randomised 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.

    Reporting group title
    Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days
    Reporting group description
    		 Subjects were randomised to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 10.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects were randomised to receive placebo matched to nirmatrelvir/ritonavir every 12 hours for 10 days from Day 1 through Day 10.

    Reporting group values
    		 Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days Placebo Total
    Number of subjects
    		 921 917 898 2736
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 842 834 832 2508
        From 65-84 years
    		 76 81 64 221
        85 years and over
    		 3 2 2 7
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 43.92 ± 14.88 42.85 ± 15.02 42.39 ± 14.36 -
    Sex: Female, Male
    Units: Subjects
        Female
    		 502 479 474 1455
        Male
    		 419 438 424 1281
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 58 52 49 159
        Asian
    		 8 15 11 34
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0
        Black or African American
    		 139 136 132 407
        White
    		 714 711 704 2129
        More than one race
    		 1 1 1 3
        Unknown or Not Reported
    		 1 2 1 4
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 664 642 643 1949
        Not Hispanic or Latino
    		 257 275 255 787
        Unknown or Not Reported
    		 0 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days
    Reporting group description
    		 Subjects were randomised 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.

    Reporting group title
    Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days
    Reporting group description
    		 Subjects were randomised to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 10.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects were randomised to receive placebo matched to nirmatrelvir/ritonavir every 12 hours for 10 days from Day 1 through Day 10.

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

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    End point title
    		 Percentage of Subjects who Developed Symptomatic RT-PCR or RAT Confirmed SARS-CoV-2 Infection Through Day 14: Among Participants With Negative RT-PCR at Baseline
    End point description
    Percentage of subjects who developed symptomatic RT-PCR or RAT confirmed SARS-Cov-2 infection were reported in this end point. Modified Intent-To-Treat (mITT) population included all subjects randomly assigned to study intervention who received at least 1 dose of study intervention and had a negative RT-PCR result at baseline.
    End point type
    Primary
    End point timeframe
    From Day 1 to Day 14
    End point values
    		 Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days Placebo
    Number of subjects analysed
    844
    830
    840
    Units: Percentage of subjects
        number (not applicable)
    2.607
    2.410
    3.929
    Statistical analysis title
    		 Nirmatrelvir300 mg+Ritonavir100 mg10 Days,Placebo
    Statistical analysis description
    Model included the fixed effects of treatment, geographic regions and presence of risk factors. Compound symmetry variance-covariance structure.
    Comparison groups
    Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days v Placebo
    Number of subjects included in analysis
    1670
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1163
    Method
    		 GEE
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    0.645
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.373
         upper limit
    		 1.115
    Statistical analysis title
    		 Nirmatrelvir300 mg +Ritonavir100mg 5 Days,Placebo
    Statistical analysis description
    Model included the fixed effects of treatment, geographic regions and presence of risk factors. Compound symmetry variance-covariance structure.
    Comparison groups
    Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days v Placebo
    Number of subjects included in analysis
    1684
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1722
    Method
    		 Generalized estimating equation (GEE)
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    0.702
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.422
         upper limit
    		 1.167

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

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    End point title
    		 Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious AEs and AEs Leading to Study and Study Drug Discontinuation
    End point description
    An AE was defined as any untoward medical occurrence in a subject 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 hospitalisation or prolongation of existing hospitalisation; 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 end point. Safety analysis set included all subjects randomly assigned to study intervention and who received at least 1 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 38)
    End point values
    		 Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days Placebo
    Number of subjects analysed
    912
    911
    898
    Units: Subjects
        TEAEs
    218
    212
    195
        SAEs
    3
    1
    2
        AEs led to discontinuation of study
    0
    0
    0
        AEs:discontinue study intervention,continued study
    10
    11
    14
    No statistical analyses for this end point

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

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    End point title
    		 Percentage of Subjects who Developed Symptomatic RT-PCR or RAT Confirmed SARS-CoV-2 Infection Through Day 14: Among Subjects With Negative RT-PCR at Baseline With Increased Risk of Severe COVID-19 Illness
    End point description
    Percentage of subjects who had a symptomatic RT-PCR or RAT confirmed SARS-Cov-2 infection were reported in this end point. 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. Modified Intent-To-Treat (mITT2) population included all subjects 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.
    End point type
    Secondary
    End point timeframe
    From Day 1 to Day 14
    End point values
    		 Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days Placebo
    Number of subjects analysed
    627
    605
    606
    Units: Percentage of subjects
        number (not applicable)
    2.871
    2.645
    3.465
    Statistical analysis title
    		 Nirmatrelvir300 mg+Ritonavir100 mg 10 Days,Placebo
    Statistical analysis description
    Model included the fixed effects of treatment, geographic regions. Compound symmetry variance-covariance structure.
    Comparison groups
    Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days v Placebo
    Number of subjects included in analysis
    1211
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.507
    Method
    		 GEE
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    0.809
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.433
         upper limit
    		 1.512
    Statistical analysis title
    		 Nirmatrelvir300 mg+Ritonavir100 mg 5 Days,Placebo
    Statistical analysis description
    Model included the fixed effects of treatment, geographic regions. Compound symmetry variance-covariance structure.
    Comparison groups
    Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days v Placebo
    Number of subjects included in analysis
    1233
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6766
    Method
    		 GEE
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    0.88
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.484
         upper limit
    		 1.602

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

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    End point title
    		 Percentage of Subjects With COVID-19 Related Hospitalization or Death From any Cause Through Day 28: Among Subjects With Negative RT-PCR at Baseline With Increased Risk of Severe COVID-19 Illness
    End point description
    The risk factors associated with severe covid-19 illness included age greater than or equal to 60 years, body mass index greater than 25, social history of smoking and presence of comorbidities. mITT2 population included all subjects 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.
    End point type
    Secondary
    End point timeframe
    From Day 1 to Day 28
    End point values
    		 Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days Placebo
    Number of subjects analysed
    627
    605
    606
    Units: Percentage of subjects
        number (not applicable)
    0
    0
    0.165
    No statistical analyses for this end point

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

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    End point title
    		 Percentage of Subjects With Asymptomatic RT-PCR or RAT Confirmed SARS-CoV-2 Infection Through Day 14: Among Subjects With Negative RT-PCR at Baseline
    End point description
    Percentage of subjects who had asymptomatic RT-PCR or RAT confirmed SARS-CoV-2 infection through day 14 among subjects with negative RT-PCR at baseline were reported in this end point. Index case was defined as subjects with symptomatic COVID-19. mITT population included all subjects randomly assigned to study intervention who received at least 1 dose of study intervention and had a negative RT-PCR result at baseline.
    End point type
    Secondary
    End point timeframe
    From Day 1 to Day 14
    End point values
    		 Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days Placebo
    Number of subjects analysed
    844
    830
    840
    Units: Percentage of subjects
        number (not applicable)
    2.014
    1.928
    3.095
    Statistical analysis title
    		 Nirmatrelvir 300 mg+Ritonavir100mg 10 Days,Placebo
    Statistical analysis description
    Model included the fixed effects of treatment, geographic regions and presence of risk factors. Compound symmetry variance-covariance structure.
    Comparison groups
    Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days v Placebo
    Number of subjects included in analysis
    1670
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1221
    Method
    		 GEE
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    0.633
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.355
         upper limit
    		 1.13
    Statistical analysis title
    		 Nirmatrelvir300 mg+Ritonavir100 mg 5 Days,Placebo
    Statistical analysis description
    Model included the fixed effects of treatment, geographic regions and presence of risk factors. Compound symmetry variance-covariance structure.
    Comparison groups
    Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days v Placebo
    Number of subjects included in analysis
    1684
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1869
    Method
    		 GEE
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    0.672
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.373
         upper limit
    		 1.213

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

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    End point title
    		 Time to RT-PCR or RAT Confirmed SARS-CoV-2 Infection Through Day 14: Among Subjects With Negative RT-PCR at Baseline
    End point description
    Number of days between first dose and confirmation of the SARS-CoV-2 infection by RT-PCR or RAT was reported in this end point. mITT population included all subjects randomly assigned to study intervention who received at least 1 dose of study intervention and had a negative RT-PCR result at baseline. 99999 indicates median and the corresponding 95% confidence interval could not be calculated as there were less number of subjects with event.
    End point type
    Secondary
    End point timeframe
    From Day 1 to Day 14
    End point values
    		 Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days Placebo
    Number of subjects analysed
    844
    830
    840
    Units: Days
        median (confidence interval 95%)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    Statistical analysis title
    		 Nirmatrelvir300 mg+Ritonavir100 mg 10 Days,Placebo
    Comparison groups
    Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days v Placebo
    Number of subjects included in analysis
    1670
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0186
    Method
    		 Logrank
    Confidence interval
    Statistical analysis title
    		 Nirmatrelvir300 mg+Ritonavir100mg 5 Days,Placebo
    Comparison groups
    Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days v Placebo
    Number of subjects included in analysis
    1684
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0368
    Method
    		 Logrank
    Confidence interval

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

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    End point title
    		 Percentage of Subjects With Symptomatic RT-PCR or RAT Confirmed SARS-CoV-2 Infection Through Day 14: Among Subjects With Positive RT-PCR at Baseline
    End point description
    Percentage of subjects 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 end point. mITT1 population included all subjects randomly assigned to study intervention who received at least 1 dose of study intervention and had a positive RT-PCR result at baseline.
    End point type
    Secondary
    End point timeframe
    From Day 1 to Day 14
    End point values
    		 Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days Placebo
    Number of subjects analysed
    38
    48
    29
    Units: Percentage of subjects
        number (not applicable)
    28.947
    45.833
    37.931
    Statistical analysis title
    		 Nirmatrelvir300 mg+Ritonavir100 mg 10 Days,Placebo
    Statistical analysis description
    Model included the fixed effects of treatment, geographic regions and presence of risk factors. Compound symmetry variance-covariance structure.
    Comparison groups
    Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days v Placebo
    Number of subjects included in analysis
    77
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4273
    Method
    		 GEE
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    1.244
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.725
         upper limit
    		 2.135
    Statistical analysis title
    		 Nirmatrelvir300 mg+Ritonavir100 mg 5 Days,Placebo
    Statistical analysis description
    Model included the fixed effects of treatment, geographic regions and presence of risk factors. Compound symmetry variance-covariance structure.
    Comparison groups
    Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days v Placebo
    Number of subjects included in analysis
    67
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4126
    Method
    		 GEE
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    0.75
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.378
         upper limit
    		 1.491

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

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    End point title
    		 Percentage of Subjects With Symptomatic RT-PCR or RAT Confirmed SARS-CoV-2 Infection Through Day 14: Among Subjects With Negative, Positive or Missing RT-PCR at Baseline
    End point description
    Percentage of subjects 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 end point. Index case was defined as subjects with symptomatic COVID-19. Modified Intent-To-Treat (mITT3) population included all subjects 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.
    End point type
    Secondary
    End point timeframe
    From Day 1 to Day 14
    End point values
    		 Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days Placebo
    Number of subjects analysed
    889
    887
    873
    Units: Percentage of subjects
        number (not applicable)
    3.712
    4.848
    5.269
    Statistical analysis title
    		 Nirmatrelvir300 mg+Ritonavir100 mg 5 Days,Placebo
    Statistical analysis description
    Model included the fixed effects of treatment, geographic regions and presence of risk factors. Compound symmetry variance-covariance structure.
    Comparison groups
    Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days v Placebo
    Number of subjects included in analysis
    1762
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1333
    Method
    		 GEE
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    0.726
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.478
         upper limit
    		 1.103
    Statistical analysis title
    		 Nirmatrelvir 300 mg + Ritonavir 100 mg 10 Days
    Statistical analysis description
    Model included the fixed effects of treatment, geographic regions and presence of risk factors. Compound symmetry variance-covariance structure.
    Comparison groups
    Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days v Placebo
    Number of subjects included in analysis
    1760
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8088
    Method
    		 GEE
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    0.953
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.645
         upper limit
    		 1.408

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

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    End point title
    		 Percentage of Subjects With no, Mild, Moderate, or Severe Signs and Symptoms Attributed to COVID-19 Through Day 28: Among Subjects With Negative RT-PCR at Baseline
    End point description
    Subjects were categorised according to severity of signs and symptoms as no, mild, moderate, severe in this end point. 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. Subjects 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 subjects randomly assigned to study intervention who received at least 1 dose of study intervention and had a negative RT-PCR result at baseline.
    End point type
    Secondary
    End point timeframe
    From Day 1 to Day 28
    End point values
    		 Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days Placebo
    Number of subjects analysed
    844
    830
    840
    Units: Percentage of subjects
    number (not applicable)
        No
    81.517
    83.373
    81.667
        Mild
    7.820
    8.193
    7.619
        Moderate
    6.872
    5.060
    7.143
        Severe
    2.133
    2.048
    2.738
        Missing
    1.659
    1.325
    0.833
    No statistical analyses for this end point

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

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    End point title
    		 Number of Days of Symptomatic RT-PCR or RAT Confirmed SARS-CoV- 2 Infection Through Day 28: Among Subjects With Negative RT-PCR at Baseline
    End point description
    This end point has been reported in terms of number of subjects according to days of symptomatic SARS-CoV-2 infection through Day 28. mITT population included all subjects 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 of Subjects Analysed'' signifies subjects evaluable for this end point.
    End point type
    Secondary
    End point timeframe
    From Day 1 to Day 28
    End point values
    		 Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days Placebo
    Number of subjects analysed
    22
    20
    33
    Units: Subjects
        1 Day of Symptoms
    1
    7
    2
        2 Days of Symptoms
    2
    0
    1
        3 Days of Symptoms
    0
    1
    4
        4 Days of Symptoms
    5
    0
    2
        5 Days of Symptoms
    1
    3
    3
        6 Days of Symptoms
    0
    1
    3
        7 Days of Symptoms
    3
    4
    4
        8 Days of Symptoms
    2
    0
    5
        9 Days of Symptoms
    0
    1
    1
        10 Days of Symptoms
    0
    0
    1
        11 Days of Symptoms
    0
    1
    1
        12 Days of Symptoms
    2
    0
    4
        13 Days of Symptoms
    1
    1
    2
        14 Days of Symptoms
    1
    1
    0
        18 Days of Symptoms
    2
    0
    0
        20 Days of Symptoms
    1
    0
    0
        26 Days of Symptoms
    1
    0
    0
    No statistical analyses for this end point

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

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    End point title
    		 Plasma Concentration Versus Time Summary of Nirmatrelvir (PF-07321332) [1]
    End point description
    Safety analysis set included all subjects randomly assigned to study intervention and who received at least 1 dose of study intervention. This end point was not planned to be analyzed for placebo arm. Here, ‘’Overall Number of Subjects Analysed signifies subjects evaluable for this end point and ‘’Number Analyzed’’ signifies subjects evaluable at specific time points.
    End point type
    Secondary
    End point timeframe
    Day 1: 1 hour post dose; Day 5: 2 hours pre-dose
    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: Only descriptive analysis was planned for this endpoint.
    End point values
    		 Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days
    Number of subjects analysed
    476
    476
    Units: Nanograms per milliliter
    arithmetic mean (standard deviation)
        Day 1: 1 hour post-dose (n=159, 156)
    1489 ± 1481.4
    1472 ± 1488.2
        Day 5: 2 hours pre-dose (n=476, 476)
    1688 ± 2093.3
    1657 ± 2068.2
    No statistical analyses for this end point

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

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    End point title
    		 Percentage of Subjects With Death Event Through Day 38: Among Participants With Negative RT-PCR at Baseline
    End point description
    Percentage of subjects with death (all-cause) event were reported in this end point. 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.
    End point type
    Secondary
    End point timeframe
    From Day 1 to Day 38
    End point values
    		 Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days Placebo
    Number of subjects analysed
    844
    830
    840
    Units: Percentage of subjects
    0
    0
    0
    No statistical analyses for this end point

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

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    End point title
    		 Viral Load in Nasal Samples Over Time: Among Subjects With Negative RT-PCR at Baseline
    End point description
    Nasal samples were collected to estimate the viral load in terms of logarithm to base 10 (log10) copies per millilitre in subjects with negative RT-PCR at baseline and were reported in this end point. mITT population included all subjects 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 subjects evaluable at specific time points.
    End point type
    Secondary
    End point timeframe
    From Day 1 to Day 14
    End point values
    		 Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days Placebo
    Number of subjects analysed
    844
    830
    840
    Units: Log 10 copies per millilitre
    arithmetic mean (standard deviation)
        Day 1(n=844, 830,840)
    0.042 ± 0.265
    0.035 ± 0.241
    0.038 ± 0.253
        Day 2(n=810,802,809)
    0.078 ± 0.523
    0.053 ± 0.409
    0.108 ± 0.611
        Day 3(n=823, 812,812)
    0.090 ± 0.586
    0.048 ± 0.374
    0.147 ± 0.760
        Day 4(n=820,808,813)
    0.081 ± 0.537
    0.057 ± 0.409
    0.165 ± 0.859
        Day 5(n=736,737,742)
    0.079 ± 0.528
    0.074 ± 0.573
    0.217 ± 1.063
        Day 6(n=817,799,812)
    0.074 ± 0.575
    0.090 ± 0.670
    0.189 ± 0.978
        Day 7(n=815,798,806)
    0.088 ± 0.586
    0.053 ± 0.536
    0.186 ± 0.883
        Day 8(n=814,796,805)
    0.096 ± 0.627
    0.081 ± 0.669
    0.159 ± 0.860
        Day 9(n=810,795,807)
    0.094 ± 0.672
    0.062 ± 0.596
    0.135 ± 0.784
        Day 10(n=733,715,714)
    0.080 ± 0.616
    0.064 ± 0.590
    0.133 ± 0.725
        Day 11(n=797,789,793)
    0.103 ± 0.673
    0.053 ± 0.511
    0.115 ± 0.707
        Day 12(n=803,783,798)
    0.106 ± 0.748
    0.051 ± 0.447
    0.103 ± 0.662
        Day 13(n=797,791,794)
    0.085 ± 0.642
    0.052 ± 0.425
    0.117 ± 0.714
        Day 14(n=696,670,686)
    0.108 ± 0.717
    0.035 ± 0.386
    0.146 ± 0.798
    No statistical analyses for this end point

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

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    End point title
    		 Viral Load in Nasal Samples Over Time: Among Subjects With Positive RT-PCR at Baseline
    End point description
    Nasal samples were collected to estimate the viral load in terms of logarithm to base 10 (log10) copies per millilitre in subjects with negative RT-PCR at baseline and were reported in this end point. mITT1 population included all subjects 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 subjects evaluable at specific time points.
    End point type
    Secondary
    End point timeframe
    From Day 1 to Day 14
    End point values
    		 Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days Placebo
    Number of subjects analysed
    38
    48
    29
    Units: Log 10 copies per millilitre
    arithmetic mean (standard deviation)
        Day 1(n=38,48,29)
    4.870 ± 2.041
    4.470 ± 1.542
    4.837 ± 1.577
        Day 2(n=38,45,28)
    3.286 ± 2.534
    2.724 ± 2.208
    3.104 ± 2.909
        Day 3(n=38,46,28)
    2.880 ± 2.641
    2.051 ± 2.212
    3.255 ± 2.702
        Day 4(n=36,47,28)
    2.600 ± 2.427
    1.514 ± 2.064
    2.721 ± 2.640
        Day 5(n=35,43,27)
    1.470 ± 2.057
    1.413 ± 1.745
    2.994 ± 2.677
        Day 6(n=38,44,28)
    1.065 ± 1.656
    0.997 ± 1.696
    2.466 ± 2.561
        Day 7(n=37,45,28)
    1.199 ± 1.747
    0.913 ± 1.762
    1.478 ± 2.212
        Day 8(n=37,45,28)
    1.212 ± 1.829
    0.942 ± 1.908
    1.072 ± 1.663
        Day 9(n=38,44,28)
    1.169 ± 1.852
    0.766 ± 1.858
    1.103 ± 1.545
        Day 10(n=35,45,28)
    0.819 ± 1.656
    0.541 ± 1.605
    0.965 ± 1.514
        Day 11(n=36,44,28)
    0.623 ± 1.170
    0.603 ± 1.044
    0.707 ± 1.116
        Day 12(n=37,44,28)
    0.532 ± 1.136
    0.670 ± 1.204
    0.436 ± 0.919
        Day 13(n=36,45,26)
    0.413 ± 1.098
    0.313 ± 1.018
    0.361 ± 0.770
        Day 14(n=31,40,25)
    0.284 ± 1.040
    0.345 ± 0.808
    0.358 ± 0.735
    No statistical analyses for this end point

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

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    End point title
    		 Number of Days of Hospitalisation and Intensive Care Unit (ICU) Stay: Among Subjects With Negative RT-PCR at Baseline
    End point description
    This end point has been presented in terms of subjects according to number of days of hospitalisation and in ICU as 0 days and more than or equal to 1 day. mITT population included all subjects randomly assigned to study intervention who received at least 1 dose of study intervention and had a negative RT-PCR result at baseline.
    End point type
    Secondary
    End point timeframe
    From Day 1 to Day 28
    End point values
    		 Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days Placebo
    Number of subjects analysed
    844
    830
    840
    Units: Subjects
        ICU Visits: 0 Day
    844
    830
    840
        ICU Visits: More than or equal to 1 day
    0
    0
    0
        Hospitalization Visits: 0 Day
    844
    830
    839
        Hospitalization Visit: More than or equal to 1 day
    0
    0
    1
    No statistical analyses for this end point

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

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    End point title
    		 Number of COVID-19 Related Medical Visits Through Day 28: Among Subjects With Negative RT-PCR at Baseline
    End point description
    In this end point, 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 subjects randomly assigned to study intervention who received at least 1 dose of study intervention and had a negative RT-PCR result at baseline.
    End point type
    Secondary
    End point timeframe
    From Day 1 to Day 28
    End point values
    		 Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days Placebo
    Number of subjects analysed
    844
    830
    840
    Units: Medical visits per day
        arithmetic mean (standard deviation)
    0.0067 ± 0.0200
    0.0057 ± 0.0201
    0.0066 ± 0.0182
    Statistical analysis title
    		 Nirmatrelvir300 mg+Ritonavir100 mg 5 Days,Placebo
    Comparison groups
    Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days v Placebo
    Number of subjects included in analysis
    1684
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7991
    Method
    		 Negative binomial regression model
    Parameter type
    		 LS Mean Ratio
    Point estimate
    0.969
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.758
         upper limit
    		 1.238
    Statistical analysis title
    		 Nirmatrelvir 300 mg + Ritonavir 100 mg 10 Days
    Comparison groups
    Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days v Placebo
    Number of subjects included in analysis
    1670
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1985
    Method
    		 Negative binomial regression model
    Parameter type
    		 LS Mean Ratio
    Point estimate
    0.847
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.657
         upper limit
    		 1.091

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From Day 1 to Day 38
    Adverse event reporting additional description
    Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. Safety population comprised of all subjects who received at least 1 dose of study intervention during the study.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.1
    Reporting groups
    Reporting group title
    Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days
    Reporting group description
    		 Subjects were randomised 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.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects were randomised to receive placebo matched to nirmatrelvir/ritonavir every 12 hours for 10 days from Day 1 through Day 10.

    Reporting group title
    Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days
    Reporting group description
    		 Subjects were randomised to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 10.

    Serious adverse events
    		 Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days Placebo Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 912 (0.33%)
    2 / 898 (0.22%)
    1 / 911 (0.11%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Injury, poisoning and procedural complications
    Overdose
         subjects affected / exposed
    0 / 912 (0.00%)
    1 / 898 (0.11%)
    0 / 911 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    1 / 912 (0.11%)
    0 / 898 (0.00%)
    0 / 911 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tibia fracture
         subjects affected / exposed
    1 / 912 (0.11%)
    0 / 898 (0.00%)
    0 / 911 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis acute
         subjects affected / exposed
    1 / 912 (0.11%)
    0 / 898 (0.00%)
    0 / 911 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    COVID-19 pneumonia
         subjects affected / exposed
    1 / 912 (0.11%)
    1 / 898 (0.11%)
    1 / 911 (0.11%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days Placebo Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    176 / 912 (19.30%)
    152 / 898 (16.93%)
    173 / 911 (18.99%)
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    2 / 912 (0.22%)
    11 / 898 (1.22%)
    6 / 911 (0.66%)
         occurrences all number
    2
    12
    8
    Activated partial thromboplastin time prolonged
         subjects affected / exposed
    11 / 912 (1.21%)
    22 / 898 (2.45%)
    14 / 911 (1.54%)
         occurrences all number
    11
    23
    15
    Fibrin D dimer increased
         subjects affected / exposed
    18 / 912 (1.97%)
    4 / 898 (0.45%)
    13 / 911 (1.43%)
         occurrences all number
    18
    5
    13
    Blood thyroid stimulating hormone increased
         subjects affected / exposed
    11 / 912 (1.21%)
    10 / 898 (1.11%)
    8 / 911 (0.88%)
         occurrences all number
    11
    11
    8
    Blood creatine phosphokinase increased
         subjects affected / exposed
    12 / 912 (1.32%)
    13 / 898 (1.45%)
    15 / 911 (1.65%)
         occurrences all number
    12
    14
    15
    Nervous system disorders
    Headache
         subjects affected / exposed
    15 / 912 (1.64%)
    29 / 898 (3.23%)
    17 / 911 (1.87%)
         occurrences all number
    16
    31
    19
    Dysgeusia
         subjects affected / exposed
    54 / 912 (5.92%)
    6 / 898 (0.67%)
    62 / 911 (6.81%)
         occurrences all number
    54
    6
    62
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    10 / 912 (1.10%)
    17 / 898 (1.89%)
    7 / 911 (0.77%)
         occurrences all number
    11
    18
    7
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    23 / 912 (2.52%)
    15 / 898 (1.67%)
    22 / 911 (2.41%)
         occurrences all number
    24
    15
    26
    Nausea
         subjects affected / exposed
    16 / 912 (1.75%)
    14 / 898 (1.56%)
    12 / 911 (1.32%)
         occurrences all number
    16
    16
    13
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    10 / 912 (1.10%)
    12 / 898 (1.34%)
    2 / 911 (0.22%)
         occurrences all number
    11
    15
    2
    Nasal congestion
         subjects affected / exposed
    4 / 912 (0.44%)
    10 / 898 (1.11%)
    3 / 911 (0.33%)
         occurrences all number
    5
    10
    3
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    20 / 912 (2.19%)
    18 / 898 (2.00%)
    17 / 911 (1.87%)
         occurrences all number
    21
    19
    17
    Nasopharyngitis
         subjects affected / exposed
    13 / 912 (1.43%)
    6 / 898 (0.67%)
    9 / 911 (0.99%)
         occurrences all number
    13
    6
    9
    COVID-19
         subjects affected / exposed
    27 / 912 (2.96%)
    36 / 898 (4.01%)
    26 / 911 (2.85%)
         occurrences all number
    27
    36
    26

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    25 Jan 2022
    Updated the secondary objective and secondary endpoint to assess viral titers in subjects with a positive RT-PCR result at baseline.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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