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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04960202
Registration number
NCT04960202
Ethics application status
Date submitted
10/07/2021
Date registered
13/07/2021
Date last updated
10/07/2025
Titles & IDs
Public title
EPIC-HR: Study of Oral PF-07321332/Ritonavir Compared With Placebo in Nonhospitalized High Risk Adults With COVID-19
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Scientific title
AN INTERVENTIONAL EFFICACY AND SAFETY, PHASE 2/3, DOUBLE-BLIND, 2-ARM STUDY TO INVESTIGATE ORALLY ADMINISTERED PF-07321332/RITONAVIR COMPARED WITH PLACEBO IN NONHOSPITALIZED SYMPTOMATIC ADULT PARTICIPANTS WITH COVID-19 WHO ARE AT INCREASED RISK OF PROGRESSING TO SEVERE ILLNESS
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Secondary ID [1]
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0
2021-002895-38
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Secondary ID [2]
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C4671005
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
COVID-19
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Condition category
Condition code
Infection
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Other infectious diseases
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Respiratory
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0
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - PF-07321332
Treatment: Drugs - Ritonavir
Treatment: Drugs - Placebo
Experimental: PF-07321332/ritonavir - Orally administered PF-07321332+ritonavir
Placebo comparator: Placebo - Orally administered placebo
Treatment: Drugs: PF-07321332
PF-07321332 (tablet)
Treatment: Drugs: Ritonavir
Ritonavir (capsule)
Treatment: Drugs: Placebo
Placebo (tablet or capsule)
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants With Covid-19 Related Hospitalization or Death From Any Cause Through Day 28- Modified Intent-To-Treat (mITT) Population
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Assessment method [1]
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Percentage of participants with COVID-19 related hospitalization or death from any cause during the first 28 days of the study was estimated using the Kaplan-Meier (KM) method. Using KM method, survival probability for each time interval was calculated as the number of participants surviving divided by the number of participants at risk. Participants who had the event, dropped out, or moved out were not counted as "at risk" i.e., participants who were lost were considered "censored" and were not counted in the denominator.
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Timepoint [1]
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From Day 1 to Day 28
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Secondary outcome [1]
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Number of Participants With Treatment Emergent Adverse Events (TEAEs)
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Assessment method [1]
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An adverse event (AE) was any untoward medical occurrence in a participant, temporarily associated with the use of study intervention, whether or not considered related to the study intervention. Serious adverse event (SAE) was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/ incapacity; congenital anomaly/birth defect; a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic and other important medical events. AEs included both SAEs and all non-SAEs. An AE was considered as TEAE if the event started on or after start date of study intervention.
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Timepoint [1]
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From start of study intervention (Day 1) up to end of safety follow-up (Day 34)
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Secondary outcome [2]
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Number of Participants With AEs Leading to Discontinuation and Serious Adverse Events (SAEs)
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Assessment method [2]
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An AE was any untoward medical occurrence in a participant, temporarily associated with the use of study treatment, whether or not considered related to the study treatment. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/ incapacity; congenital anomaly/birth defect; a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic and other important medical events.
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Timepoint [2]
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From start of study intervention (Day 1) up to end of safety follow-up (Day 34)
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Secondary outcome [3]
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Percentage of Participants With Covid-19 Related Hospitalization or Death From Any Cause Through Day 28- Modified Intent-To-Treat 1 (mITT1) Population
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Assessment method [3]
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Percentage of participants with COVID-19 related hospitalization or death from any cause during the first 28 days of the study was estimated using the Kaplan-Meier method.
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Timepoint [3]
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From Day 1 to Day 28
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Secondary outcome [4]
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Time to Sustained Alleviation of All Targeted COVID-19 Signs and Symptoms Through Day 28- mITT Population
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Assessment method [4]
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Sustained alleviation of all targeted COVID-19 signs/symptoms was defined as the event occurring on the first 4 consecutive days when all symptoms scored as moderate or severe at the time of enrollment were scored as mild or absent and those scored mild or absent at the time of enrollment were scored as absent. The first day of the 4 consecutive-day period was considered date of first event. Time to sustained alleviation (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained alleviation (censored), time was calculated as censoring date (last date on which symptom alleviation was assessed) minus first dose date plus 1 or Day 25 whichever occurred first.
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Timepoint [4]
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From Day 1 (baseline) to Day 28
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Secondary outcome [5]
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Time to Sustained Alleviation of All Targeted COVID-19 Signs and Symptoms Through Day 28- mITT1 Population
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Assessment method [5]
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Sustained alleviation of all targeted COVID-19 signs/symptoms was defined as the event occurring on the first 4 consecutive days when all symptoms scored as moderate or severe at the time of enrollment were scored as mild or absent and those scored mild or absent at the time of enrollment were scored as absent. The first day of the 4 consecutive-day period was considered date of first event. Time to sustained alleviation (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained alleviation (censored), time was calculated as censoring date (last date on which symptom alleviation was assessed) minus first dose date plus 1 or Day 25 whichever occurred first.
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Timepoint [5]
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0
From Day 1 (baseline) to Day 28
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Secondary outcome [6]
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Time to Sustained Alleviation of All Targeted COVID-19 Signs and Symptoms Through Day 28- Modified Intent-to-Treat 2 (mITT2) Population
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Assessment method [6]
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Sustained alleviation of all targeted COVID-19 signs/symptoms was defined as the event occurring on the first 4 consecutive days when all symptoms scored as moderate or severe at the time of enrollment were scored as mild or absent and those scored mild or absent at the time of enrollment were scored as absent. The first day of the 4 consecutive-day period was considered date of first event. Time to sustained alleviation (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained alleviation (censored), time was calculated as censoring date (last date on which symptom alleviation was assessed) minus first dose date plus 1 or Day 25 whichever occurred first.
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Timepoint [6]
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0
From Day 1 (baseline) to Day 28
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Secondary outcome [7]
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Percentage of Participants With Severe Covid-19 Signs and Symptoms Through Day 28- mITT Population
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Assessment method [7]
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Participants were required to record the severity of their Covid-19 symptoms over the past 24 hours daily on a 4-point scale ranging from 0 to 3, higher scores indicated more severity. The scale was reported as 0= no symptoms, 1=mild, 2=moderate and 3=severe. A participant with severe score for any targeted symptoms post-baseline was counted as severe. Percentage of participants with severe Covid-19 signs and symptoms were reported.
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Timepoint [7]
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From Day 1 to Day 28
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Secondary outcome [8]
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Percentage of Participants With Severe Covid-19 Signs and Symptoms Through Day 28- mITT1 Population
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Assessment method [8]
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Participants were required to record the severity of their Covid-19 symptoms over the past 24 hours daily on a 4-point scale ranging from 0 to 3, higher scores indicated more severity. The scale was reported as 0= no symptoms, 1=mild, 2=moderate and 3=severe. A participant with severe score for any targeted symptoms post-baseline was counted as severe. Percentage of participants with severe Covid-19 signs and symptoms were reported.
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Timepoint [8]
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From Day 1 to Day 28
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Secondary outcome [9]
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Percentage of Participants With Severe Covid-19 Signs and Symptoms Through Day 28- mITT2 Population
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Assessment method [9]
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Participants were required to record the severity of their Covid-19 symptoms over the past 24 hours daily on a 4-point scale ranging from 0 to 3, higher scores indicated more severity. The scale was reported as 0= no symptoms, 1=mild, 2=moderate and 3=severe. A participant with severe score for any targeted symptoms post-baseline was counted as severe. Percentage of participants with severe Covid-19 signs and symptoms were reported.
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Timepoint [9]
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From Day 1 to Day 28
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Secondary outcome [10]
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Time to Sustained Resolution of All Targeted COVID-19 Signs and Symptoms Through Day 28- mITT Population
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Assessment method [10]
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Sustained resolution was defined as when all targeted symptoms were scored as absent for 4 consecutive days. Time to sustained resolution (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained resolution (censored), time was calculated as censoring date (last date on which symptom resolution was assessed) minus first dose date plus 1 or Day 25 whichever occurred first.
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Timepoint [10]
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0
From Day 1 (baseline) to Day 28
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Secondary outcome [11]
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Time to Sustained Resolution of All Targeted COVID-19 Signs and Symptoms Through Day 28- mITT1 Population
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Assessment method [11]
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Sustained resolution was defined as when all targeted symptoms were scored as absent for 4 consecutive days. Time to sustained resolution (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained resolution (censored), time was calculated as censoring date (last date on which symptom resolution was assessed) minus first dose date plus 1 or Day 25 whichever occurred first.
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Timepoint [11]
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0
From Day 1 (baseline) to Day 28
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Secondary outcome [12]
0
0
Time to Sustained Resolution of All Targeted COVID-19 Signs and Symptoms Through Day 28- mITT2 Population
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Assessment method [12]
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Sustained resolution was defined as when all targeted symptoms were scored as absent for 4 consecutive days. Time to sustained resolution (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained resolution (censored), time was calculated as censoring date (last date on which symptom resolution was assessed) minus first dose date plus 1 or Day 25 whichever occurred first.
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Timepoint [12]
0
0
From Day 1 (baseline) to Day 28
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Secondary outcome [13]
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0
Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT Population
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Assessment method [13]
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Sustained alleviation of each targeted COVID-19 signs/symptoms was defined as the event occurring on the first 4 consecutive days when each symptom scored as moderate or severe at the time of enrollment were scored as mild or absent and those scored mild or absent at the time of enrollment were scored as absent. The first day of the 4 consecutive-day period was considered date of first event. Time to sustained alleviation (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained alleviation (censored), time was calculated as censoring date (last date on which symptom alleviation was assessed) minus first dose date plus 1 or Day 25 whichever occurred first.
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Timepoint [13]
0
0
From Day 1 (baseline) to Day 28
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Secondary outcome [14]
0
0
Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population
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Assessment method [14]
0
0
Sustained alleviation of each targeted COVID-19 signs/symptoms was defined as the event occurring on the first 4 consecutive days when each symptom scored as moderate or severe at the time of enrollment were scored as mild or absent and those scored mild or absent at the time of enrollment were scored as absent. The first day of the 4 consecutive-day period was considered date of first event. Time to sustained alleviation (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained alleviation (censored), time was calculated as censoring date (last date on which symptom alleviation was assessed) minus first dose date plus 1 or Day 25 whichever occurred first.
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Timepoint [14]
0
0
From Day 1 (baseline) to Day 28
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Secondary outcome [15]
0
0
Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population
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Assessment method [15]
0
0
Sustained alleviation of each targeted COVID-19 signs/symptoms was defined as the event occurring on the first 4 consecutive days when each symptom scored as moderate or severe at the time of enrollment were scored as mild or absent and those scored mild or absent at the time of enrollment were scored as absent. The first day of the 4 consecutive-day period was considered date of first event. Time to sustained alleviation (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained alleviation (censored), time was calculated as censoring date (last date on which symptom alleviation was assessed) minus first dose date plus 1 or Day 25 whichever occurred first.
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Timepoint [15]
0
0
From Day 1 (baseline) to Day 28
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Secondary outcome [16]
0
0
Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT Population
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Assessment method [16]
0
0
Sustained resolution was defined as when each targeted symptom was scored as absent for 4 consecutive days. Time to sustained resolution (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained resolution (censored), time was calculated as censoring date (last date on which symptom resolution was assessed) minus first dose date plus 1 or Day 25 whichever occurred first.
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Timepoint [16]
0
0
From Day 1 (baseline) to Day 28
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Secondary outcome [17]
0
0
Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population
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Assessment method [17]
0
0
Sustained resolution was defined as when each targeted symptom was scored as absent for 4 consecutive days. Time to sustained resolution (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained resolution (censored), time was calculated as censoring date (last date on which symptom resolution was assessed) minus first dose date plus 1 or Day 25 whichever occurred first.
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Timepoint [17]
0
0
From Day 1 (baseline) to Day 28
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Secondary outcome [18]
0
0
Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population
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Assessment method [18]
0
0
Sustained resolution was defined as when each targeted symptom was scored as absent for 4 consecutive days. Time to sustained resolution (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained resolution (censored), time was calculated as censoring date (last date on which symptom resolution was assessed) minus first dose date plus 1 or Day 25 whichever occurred first.
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Timepoint [18]
0
0
From Day 1 (baseline) to Day 28
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Secondary outcome [19]
0
0
Number of Participants With Progression to a Worsening Status in 1 or More Self-reported COVID-19 Associated Symptoms Through Day 28-mITT Population
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Assessment method [19]
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Participants were required to record the severity of their Covid-19 symptoms over the past 24 hours daily on a 4-point scale where 0 = no symptoms; 1= mild; 2= moderate; and 3= severe. Vomiting and diarrhea were each rated on a 4-point frequency scale where 0= no occurrence, 1= mild for 1 to 2 times, 2= moderate for 3 to 4 times, and 3= severe for 5 or greater. Progression to a worsening status for any targeted symptom was based up on increasing severity (i.e. the first time any targeted symptoms worsened after treatment relative to baseline).
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Timepoint [19]
0
0
From Day 1 (baseline) to Day 28
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Secondary outcome [20]
0
0
Number of Participants With Progression to a Worsening Status in 1 or More Self-reported COVID-19 Associated Symptoms Through Day 28-mITT1 Population
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Assessment method [20]
0
0
Participants were required to record the severity of their Covid-19 symptoms over the past 24 hours daily on a 4-point scale where 0 = no symptoms; 1= mild; 2= moderate; and 3= severe. Vomiting and diarrhea were each rated on a 4-point frequency scale where 0= no occurrence, 1= mild for 1 to 2 times, 2= moderate for 3 to 4 times, and 3= severe for 5 or greater. Progression to a worsening status for any targeted symptom was based up on increasing severity (i.e. the first time any targeted symptoms worsened after treatment relative to baseline).
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Timepoint [20]
0
0
From Day 1 (baseline) to Day 28
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Secondary outcome [21]
0
0
Number of Participants With Progression to a Worsening Status in 1 or More Self-reported COVID-19 Associated Symptoms Through Day 28-mITT2 Population
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Assessment method [21]
0
0
Participants were required to record the severity of their Covid-19 symptoms over the past 24 hours daily on a 4-point scale where 0 = no symptoms; 1= mild; 2= moderate; and 3= severe. Vomiting and diarrhea were each rated on a 4-point frequency scale where 0= no occurrence, 1= mild for 1 to 2 times, 2= moderate for 3 to 4 times, and 3= severe for 5 or greater. Progression to a worsening status for any targeted symptom was based up on increasing severity (i.e. the first time any targeted symptoms worsened after treatment relative to baseline).
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Timepoint [21]
0
0
From Day 1 (baseline) to Day 28
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Secondary outcome [22]
0
0
Percentage of Participants With a Resting Peripheral Oxygen Saturation >=95% at Days 1 and 5- mITT Population
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Assessment method [22]
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0
In this outcome measure, the percentage of participants with a resting peripheral oxygen saturation \>=95% were reported.
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Timepoint [22]
0
0
Day 1, 5
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Secondary outcome [23]
0
0
Percentage of Participants With a Resting Peripheral Oxygen Saturation >=95% at Days 1 and 5- mITT1 Population
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Assessment method [23]
0
0
In this outcome measure, the percentage of participants with a resting peripheral oxygen saturation \>=95% were reported.
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Timepoint [23]
0
0
Day 1, 5
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Secondary outcome [24]
0
0
Percentage of Participants With a Resting Peripheral Oxygen Saturation >=95% at Days 1 and 5- mITT2 Population
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Assessment method [24]
0
0
In this outcome measure, the percentage of participants with a resting peripheral oxygen saturation \>=95% were reported.
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Timepoint [24]
0
0
Day 1, 5
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Secondary outcome [25]
0
0
Percentage of Participants Who Died Through Week 24- mITT Population
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Assessment method [25]
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0
In this outcome measure, percentage of participants with death due to any cause was presented.
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Timepoint [25]
0
0
From Day 1 up to Week 24
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Secondary outcome [26]
0
0
Percentage of Participants Who Died Through Week 24- mITT1 Population
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Assessment method [26]
0
0
In this outcome measure, percentage of participants with death due to any cause was presented.
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Timepoint [26]
0
0
From Day 1 up to Week 24
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Secondary outcome [27]
0
0
Percentage of Participants Who Died Through Week 24- mITT2 Population
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Assessment method [27]
0
0
In this outcome measure, percentage of participants with death due to any cause was presented.
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Timepoint [27]
0
0
From Day 1 up to Week 24
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Secondary outcome [28]
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0
Plasma Concentration Versus Time Summary of PF-07321332
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Assessment method [28]
0
0
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Timepoint [28]
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0
1 Hour post-dose on Day 1 and pre-dose on Day 5
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Secondary outcome [29]
0
0
Change From Baseline in Logarithm to Base10 (Log10) Transformed Viral Load at Day 3, 5, 10 and 14- mITT Population
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Assessment method [29]
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0
The viral load was measured in nasal or nasopharyngeal samples using reverse transcription polymerase chain reaction (RT-PCR).
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Timepoint [29]
0
0
Baseline, Day 3, 5, 10 and 14
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Secondary outcome [30]
0
0
Change From Baseline in Log10 Transformed Viral Load at Day 3, 5, 10 and 14- mITT1 Population
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Assessment method [30]
0
0
The viral load was measured in nasal or nasopharyngeal samples using RT-PCR.
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Timepoint [30]
0
0
Baseline, Day 3, 5, 10 and 14
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Secondary outcome [31]
0
0
Change From Baseline in Log10 Transformed Viral Load at Day 3, 5, 10 and 14- mITT2 Population
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Assessment method [31]
0
0
The viral load was measured in nasal or nasopharyngeal samples using RT-PCR.
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Timepoint [31]
0
0
Baseline, Day 3, 5, 10 and 14
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Secondary outcome [32]
0
0
Number of COVID-19 Related Medical Visits- mITT Population
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Assessment method [32]
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0
Medical visits included emergency room, practitioner's office, home healthcare services, urgent care, telephone consultation, outpatient infusion center, other, COVID-19-related-hospitalization (intensive care unit \[ICU\] and non-ICU stays). In this outcome measure, COVID-19-related medical visits of participants were reported.
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Timepoint [32]
0
0
From Day 1 up to Day 34
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Secondary outcome [33]
0
0
Number of COVID-19 Related Medical Visits- mITT1 Population
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Assessment method [33]
0
0
Medical visits included emergency room, practitioner's office, home healthcare services, urgent care, telephone consultation, outpatient infusion center, other, COVID-19-related-hospitalization (ICU and non-ICU stays). In this outcome measure, COVID-19-related medical visits of participants were reported.
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Timepoint [33]
0
0
From Day 1 up to Day 34
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Secondary outcome [34]
0
0
Number of COVID-19 Related Medical Visits- mITT2 Population
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Assessment method [34]
0
0
Medical visits included emergency room, practitioner's office, home healthcare services, urgent care, telephone consultation, outpatient infusion center, other, COVID-19-related-hospitalization (ICU and non-ICU stays). In this outcome measure, COVID-19-related medical visits of participants were reported.
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Timepoint [34]
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0
From Day 1 up to Day 34
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Secondary outcome [35]
0
0
Number of Days in Hospital and ICU for the Treatment of COVID-19- mITT Population
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Assessment method [35]
0
0
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Timepoint [35]
0
0
From Day 1 up to Day 34
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Secondary outcome [36]
0
0
Number of Days in Hospital and ICU for the Treatment of COVID-19- mITT1 Population
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Assessment method [36]
0
0
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Timepoint [36]
0
0
From Day 1 up to Day 34
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Secondary outcome [37]
0
0
Number of Days in Hospital and ICU for the Treatment of COVID-19- mITT2 Population
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Assessment method [37]
0
0
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Timepoint [37]
0
0
From Day 1 up to Day 34
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Eligibility
Key inclusion criteria
* Confirmed SARS-CoV-2 infection within 5 days prior to randomization
* Initial onset of COVID-19 signs/symptoms within 5 days prior to the day of randomization and at least 1 of the specified COVID-19 signs/symptoms present on the day of randomization
* Fertile participants must agree to use a highly effective method of contraception
* Has at least 1 characteristic or underlying medical condition associated with an increased risk of developing severe illness from COVID-19
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* History of or need for hospitalization for the medical treatment of COVID-19
* Prior to current disease episode, any confirmed SARS-CoV-2 infection
* Known medical history of active liver disease
* Receiving dialysis or have known moderate to severe renal impairment
* Known human immunodeficiency virus (HIV) infection with a viral load greater than 400 copies/mL or taking prohibited medications for HIV treatment
* Suspected or confirmed concurrent active systemic infection other than COVID-19
* History of hypersensitivity or other contraindication to any of the components of the study intervention
* Current or expected use of any medications or substances that are highly dependent on CYP3A4 for clearance or are strong inducers of CYP3A4
* Has received or is expected to receive convalescent COVID-19 plasma
* Has received or is expected to receive any dose of a SARS-CoV-2 vaccine before the Day 34 visit
* Participating in another interventional clinical study with an investigational compound or device, including those for COVID-19 through the long-term follow-up visit
* Known prior participation in this trial or other trial involving PF-07321332
* Oxygen saturation of <92% on room air, or on their standard home oxygen supplementation for those who regularly receive chronic supplementary oxygen for an underlying lung condition
* Females who are pregnant or breastfeeding
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
16/07/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
25/04/2022
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Sample size
Target
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Accrual to date
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Final
2091
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
Alabama
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Country [2]
0
0
United States of America
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State/province [2]
0
0
Arizona
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Country [3]
0
0
United States of America
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State/province [3]
0
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California
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India
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Trabzon
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Dnipro
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Kharkiv
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Ukraine
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Kyiv
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Ukraine
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Vinnytsia
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Ukraine
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Zhytomyr
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Pfizer
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to determine whether PF-07321332/ritonavir is safe and effective for the treatment of adults who are ill with COVID-19 and do not need to be in the hospital, but are at an increased risk of developing severe illness. Throughout the study period, provision will be made to allow study visits to be conducted at a participant's home or another non-clinic location if available. The total study duration is up to 24 weeks.
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Trial website
https://clinicaltrials.gov/study/NCT04960202
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Trial related presentations / publications
Hammond J, Leister-Tebbe H, Gardner A, Abreu P, Bao W, Wisemandle W, Baniecki M, Hendrick VM, Damle B, Simon-Campos A, Pypstra R, Rusnak JM; EPIC-HR Investigators. Oral Nirmatrelvir for High-Risk, Nonhospitalized Adults with Covid-19. N Engl J Med. 2022 Apr 14;386(15):1397-1408. doi: 10.1056/NEJMoa2118542. Epub 2022 Feb 16.
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
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Pfizer CT.gov Call Center
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Pfizer
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Contact person for scientific queries
Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/02/NCT04960202/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/02/NCT04960202/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT04960202
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