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

Primary Purpose

COVID-19

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
PF-07321332
Ritonavir
Placebo
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

Sites / Locations

  • Cahaba Research Inc
  • The Institute for Liver Health dba Arizona Clinical Trials
  • The Institute for Liver Health dba Arizona Clinical Trials
  • Hope Clinical Research
  • Ascada Research
  • Atella Clinical Research LLC.
  • Ark Clinical Research
  • American Institute of Research
  • South Bay Clinical Research Institute
  • Hope Clinical Research (COVID Satellite Site)
  • Future Innovative Treatments, LLC
  • Xera Med Research
  • MOORE Clinical Research, Inc.
  • Innovative Research of West Florida, Inc.
  • Herco Medical and Research Center Inc
  • Advance Clinical Research Group
  • Beautiful Minds Clinical Research Center
  • Unlimited Medical Research Group, LLC
  • Qway Research
  • Eastern Research Inc
  • Inpatient Research Clinic
  • Doral Medical Research LLC.
  • Doral Medical Research,LLC
  • Advanced Pulmonary Research Institute
  • Savin Medical Group, LLC
  • Angels Clinical Research Institute
  • LCC Medical Research Institute, LLC
  • Premium Medical Research Corp
  • Global Health Clinical Trials Corp
  • South Florida Research Center, Inc.
  • Suncoast Research Group, LLC
  • I.V.A.M. Clinical & Investigational Center, LLC
  • C'A Research
  • ProLive Medical Research, Corp.
  • Entrust Clinical Research
  • Reed Medical Research
  • Kendall South Medical Center
  • Clinical Site Partners, Inc d/b/a CSP Miami
  • Coral Research Clinic Corp
  • Omega Research Orlando, LLC
  • NAPA Research LLC
  • CDC Research Institute
  • GCP, Global Clinical Professionals
  • USPA Advance Concept Medical Research Group LLC
  • Sunrise Research Institute
  • Santos Research Center, CORP
  • Clinical Site Partners, Inc. dba CSP Orlando
  • Research by Design, LLC
  • New Orleans Sinus Center (COVID-19 Testing)
  • Tandem Clinical Research GI, LLC
  • Mercury Street Medical Group, PLLC
  • Excel Clinical Research
  • Meridian Clinical Research, LLC
  • Monroe Biomedical Research
  • Accellacare
  • Premier Medical Group
  • PharmaTex Research, LLC
  • ARC Clinical Research at William Cannon
  • St Hope Foundation
  • Conroe Willis Medical Research
  • South Texas Clinical Research
  • SignatureCare Emergency Center
  • Trio Clinical Trials, LLC
  • C & R Research Services USA
  • Next Level Urgent Care
  • SMS Clinical Research, LLC
  • SMS Clinical Research
  • LinQ Research, LLC
  • Epic Medical Research
  • Sun Research Institute
  • BFHC Research
  • Tranquility Research
  • TPMG (Tidewater Physicians Multispecialty Group) Clinical Research
  • Instituto de Investigaciones Clinicas Zarate
  • Hospital De Clínicas Presidente Dr.Nicolas Avellaneda
  • Chronos Pesquisa Clinica
  • Hospital Agamenon Magalhaes
  • CECIP JAÚ - Centro de Estudos Clínicos do Interior Paulista - LTDA
  • Individual Practice for Primary Medical Care - IPPMC - Dr. P. Panayotov EOOD
  • "Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases-Haskovo" Ltd
  • MHAT "Sv.Ivan. Rilski'' Kozloduy EOOD
  • Diagnostic-Consultative Center I Lom EOOD
  • Multiprofile Hospital for Active Treatment- Sveti Nikolay Chudotvoretz EOOD
  • Medical centre Leo Clinic EOOD
  • MHAT Heart and Brain EAD
  • DCC Sveti Georgi EOOD
  • MHAT "St. Panteleimon "- Plovdiv
  • Multiprofile Hospital for Active Treatment Sveti Ivan Rilski - Razgrad AD
  • "Specialized Hospital for Active Treatment of Pneumo-Physiatric Diseases Dr. Dimitar Gramatikov -
  • UMHAT Medica Ruse OOD
  • Multiprofile Hospital for Active Treatment - Samokov EOOD
  • Medical Center-1-Sevlievo EOOD
  • Multiprofile Hospital For Active Treatment Shumen AD
  • Multiprofile hospital for active treatment - Sliven to Military Medical Academy
  • MHAT "Dr. Ivan Seliminski" AD, Sliven
  • Diagnostic-Consultative Center XXII- Sofia ЕООD
  • MHAT "St. Sofia" EOOD
  • Specialized hospital for active treatment in pulmonology and phthisiology "Stara Zagora" EOOD
  • Multiprofile Hospital for Active Treatment Targovishte AD
  • Outpatient Clinic for Primary Outpatient Medical Care "Puls" - Dr. Mladen Buchvarov EOOD
  • Medical center Leo Clinic EOOD
  • Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases Vratsa EOOD
  • Fundacion Cardiomet Cequin
  • Zdraví-Fit, s.r.o.
  • Nemocnice Slany
  • Trial Pharma Kft.
  • Debreceni Egyetem Klinikai Kozpont Infektologiai Klinika
  • Agria-Study Kft.
  • Trial Pharma Kft.
  • Medifarma-98 Kft.
  • AIIMS Raipur
  • Jupiter Hospital
  • BGS Global Institute of Medical Sciences and Hospital
  • Lisie Hospital
  • Jehangir Clinical Development Centre Pvt. Ltd
  • Lifepoint Research LLP
  • Jawahar Lal Nehru Medical College
  • Apex Hospitals Pvt Ltd
  • Maharaja Agrasen Superspeciality Hospital
  • Nil Ratan Sircar Medical College and Hospital
  • Aakash Healthcare Private Limited
  • Sardar Patel Medical College
  • International University of Health and Welfare Narita Hospital
  • National Hokkaido Medical Center
  • Rinku General Medical Center
  • Tokyo Medical University Hachioji Medical Center
  • National Center for Global Health and Medicine
  • Kyungpook National University Chilgok Hospital
  • Incheon Medical Center
  • Chonnam National University Bitgoeul Hospital
  • SMG-SNU Boramae Medical Center
  • Hospital Umum Sarawak
  • Hospital Miri
  • Clinical Research Institute Saltillo S.A. de C.V.
  • Asociacion Mexicana para la Investigacion Clinica A.C. (AMIC)
  • Instituto Jalisciense de Metabolismo, S.C.
  • JM Research SC
  • Christus - Latam Hub Center of Excellence and Innovation Center S.C.
  • Eukarya Pharmasite S.C.
  • Oaxaca Site Management Organization
  • InfectoLab Consultorios de Especialidad en Infectologia
  • Kohler & Milstein Research S.A. de C.V.
  • EME RED Hospitalaria
  • Centro de Investigacion Clinica Del Pacifico SA de CV
  • Hospital Cardiologica Aguascalientes
  • Instituto de Investigaciones Clínicas para la Salud
  • FAICIC S. de R.L. de C.V.
  • Sociedad de Metabolismo y Corazon S.C.
  • Arké SMO S.A de C.V
  • KLIMED Marek Klimkiewicz
  • Centrum Badań Klinicznych Piotr Napora Lekarze Spółka Partnerska
  • Clinical Research Management Group Inc
  • Advance Medical Research Center
  • LLC Trekhgorka Medicine
  • Barnaul City Hospital Number 5
  • KDC "Evromedservis", OJSC
  • Smolensk State Medical University
  • MERC Welkom
  • East Rand Research Centre T/A Worthwhile Clinical Trials
  • Botho Ke Bontle Health Services
  • Synapta Clinical Research Center
  • Limpopo Clinical Research Initiative
  • MERC Middelburg
  • Eba Centelles
  • Complexo Hospitalario Universitario da Coruna
  • Bangkok Centre Hotel
  • Chula Field Hospital, Chulalongkorn University Sport center (Chantanayingyong Gymnasium)
  • Thai Red Cross Emerging Infectious Diseases (EDI) Clinic
  • The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT),
  • Faculty of Medicine - Khon Kaen University
  • Department of Internal Medicine, Faculty of Medicine, Prince of Songkla University,
  • Ankara University Medical Faculty, Ibni-Sina Hospital
  • Hacettepe University Medical Faculty Hospital
  • Akdeniz Universitesi Hastanesi
  • Istanbul Medipol University Clinical Research Ethics Committee
  • Gaziantep University Medical Faculty
  • Istanbul Yedikule Gogus Hastaliklari ve Gogus Cerrahisi Egitim Arastirma Hastanesi
  • Istanbul University Cerrahpasa-Cerrahpasa Medical Faculty
  • Acibadem Saglik Hizmetleri ve Tic.A.S, Acibadem Atakent Hastanesi
  • Istanbul Universitesi Klinik Arastirmalar Mukemmeliyet Uygulama ve Arastirma Merkezi
  • Basaksehir Cam ve Sakura Sehir Hastanesi
  • Kocaeli University Medical Faculty
  • Sbü Dr. Suat Seren Göğüs Hastaliklari Ve Cerrahisi Eğitim Ve Araştirma Hastanesi
  • Mersin University Health Research and Application Hospital
  • Sakarya University Training and Research Hospital
  • Karadeniz Teknik Universitesi Farabi Hastanesi
  • Communal non-profit enterprise "City Clinical Hospital #16" of Dnipro City Council
  • Municipal Nonprofit Enterprise "Ivano-Frankivsk Regional Clinical Infectious Diseases Hospital of
  • Communal nonprofit enterprise "Central City Clinical Hospital of Ivano-Frankivsk City Council"
  • Municipal Nonprofit Enterprise "City Student Hospital" of Kharkiv City Council
  • Municipal Nonprofit Enterprise of Kharkiv Regional Council "Regional Clinical Infectious Diseases
  • "Municipal Non-Profit Enterprise "Alexander Clinical Hospital of Kyiv" of the Kyiv City Council
  • Municipal non-commercial enterprise "Kyiv City Clinical Hospital #1" Of Executive Body Of the Kyiv
  • Kyiv Railway Clinical Hospital No.2 of Branch "Health Center of the Public Joint Stock Company
  • Polyclinic of Center for Medical Services and Rehabilitation of State Joint-Stock Holding Company
  • Municipal NonProfit Enterprise of the Lviv Regional Council Lviv Regional Information and Analitical
  • Municipal Nonprofit Enterprise "Lviv City Clinic Hospital #4"
  • Municipal Enterprise "Poltava Regional Clinical Infectious Diseases Hospital" of Poltava Regional
  • Municipal Enterprise "Volyn Regional Clinical Hospital" of Volyn Regional Council
  • Municipal Non-commercial Enterprise "Vinnytsia City Clinical Hospital №1"
  • Communal Enterprise "Hospital #1" of Zhytomyr City Council

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

PF-07321332/ritonavir

Placebo

Arm Description

Orally administered PF-07321332+ritonavir

Orally administered placebo

Outcomes

Primary Outcome Measures

Percentage of Participants With Covid-19 Related Hospitalization or Death From Any Cause Through Day 28- Modified Intent-To-Treat (mITT) Population
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.

Secondary Outcome Measures

Number of Participants With Treatment Emergent Adverse Events (TEAEs)
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.
Number of Participants With AEs Leading to Discontinuation and Serious Adverse Events (SAEs)
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.
Percentage of Participants With Covid-19 Related Hospitalization or Death From Any Cause Through Day 28- Modified Intent-To-Treat 1 (mITT1) Population
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.
Time to Sustained Alleviation of All Targeted COVID-19 Signs and Symptoms Through Day 28- mITT Population
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.
Time to Sustained Alleviation of All Targeted COVID-19 Signs and Symptoms Through Day 28- mITT1 Population
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.
Time to Sustained Alleviation of All Targeted COVID-19 Signs and Symptoms Through Day 28- Modified Intent-to-Treat 2 (mITT2) Population
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.
Percentage of Participants With Severe Covid-19 Signs and Symptoms Through Day 28- mITT Population
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.
Percentage of Participants With Severe Covid-19 Signs and Symptoms Through Day 28- mITT1 Population
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.
Percentage of Participants With Severe Covid-19 Signs and Symptoms Through Day 28- mITT2 Population
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.
Time to Sustained Resolution of All Targeted COVID-19 Signs and Symptoms Through Day 28- mITT Population
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.
Time to Sustained Resolution of All Targeted COVID-19 Signs and Symptoms Through Day 28- mITT1 Population
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.
Time to Sustained Resolution of All Targeted COVID-19 Signs and Symptoms Through Day 28- mITT2 Population
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.
Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT Population
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.
Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population
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.
Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population
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.
Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT Population
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.
Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population
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.
Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population
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.
Number of Participants With Progression to a Worsening Status in 1 or More Self-reported COVID-19 Associated Symptoms Through Day 28-mITT Population
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).
Number of Participants With Progression to a Worsening Status in 1 or More Self-reported COVID-19 Associated Symptoms Through Day 28-mITT1 Population
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).
Number of Participants With Progression to a Worsening Status in 1 or More Self-reported COVID-19 Associated Symptoms Through Day 28-mITT2 Population
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).
Percentage of Participants With a Resting Peripheral Oxygen Saturation >=95% at Days 1 and 5- mITT Population
In this outcome measure, the percentage of participants with a resting peripheral oxygen saturation >=95% were reported.
Percentage of Participants With a Resting Peripheral Oxygen Saturation >=95% at Days 1 and 5- mITT1 Population
In this outcome measure, the percentage of participants with a resting peripheral oxygen saturation >=95% were reported.
Percentage of Participants With a Resting Peripheral Oxygen Saturation >=95% at Days 1 and 5- mITT2 Population
In this outcome measure, the percentage of participants with a resting peripheral oxygen saturation >=95% were reported.
Percentage of Participants Who Died Through Week 24- mITT Population
In this outcome measure, percentage of participants with death due to any cause was presented.
Percentage of Participants Who Died Through Week 24- mITT1 Population
In this outcome measure, percentage of participants with death due to any cause was presented.
Percentage of Participants Who Died Through Week 24- mITT2 Population
In this outcome measure, percentage of participants with death due to any cause was presented.
Plasma Concentration Versus Time Summary of PF-07321332
Change From Baseline in Logarithm to Base10 (Log10) Transformed Viral Load at Day 3, 5, 10 and 14- mITT Population
The viral load was measured in nasal or nasopharyngeal samples using reverse transcription polymerase chain reaction (RT-PCR).
Change From Baseline in Log10 Transformed Viral Load at Day 3, 5, 10 and 14- mITT1 Population
The viral load was measured in nasal or nasopharyngeal samples using RT-PCR.
Change From Baseline in Log10 Transformed Viral Load at Day 3, 5, 10 and 14- mITT2 Population
The viral load was measured in nasal or nasopharyngeal samples using RT-PCR.
Number of COVID-19 Related Medical Visits- mITT Population
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.
Number of COVID-19 Related Medical Visits- mITT1 Population
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.
Number of COVID-19 Related Medical Visits- mITT2 Population
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.
Number of Days in Hospital and ICU for the Treatment of COVID-19- mITT Population
Number of Days in Hospital and ICU for the Treatment of COVID-19- mITT1 Population
Number of Days in Hospital and ICU for the Treatment of COVID-19- mITT2 Population

Full Information

First Posted
July 10, 2021
Last Updated
January 13, 2023
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT04960202
Brief Title
EPIC-HR: Study of Oral PF-07321332/Ritonavir Compared With Placebo in Nonhospitalized High Risk Adults With COVID-19
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
July 16, 2021 (Actual)
Primary Completion Date
December 9, 2021 (Actual)
Study Completion Date
April 25, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Eligible participants with a confirmed diagnosis of SARS-CoV-2 infection will be randomized (1:1) to receive PF-07321332/ritonavir or placebo orally every 12 hours for 5 days (10 doses total).
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2246 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PF-07321332/ritonavir
Arm Type
Experimental
Arm Description
Orally administered PF-07321332+ritonavir
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Orally administered placebo
Intervention Type
Drug
Intervention Name(s)
PF-07321332
Intervention Description
PF-07321332 (tablet)
Intervention Type
Drug
Intervention Name(s)
Ritonavir
Intervention Description
Ritonavir (capsule)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo (tablet or capsule)
Primary Outcome Measure Information:
Title
Percentage of Participants With Covid-19 Related Hospitalization or Death From Any Cause Through Day 28- Modified Intent-To-Treat (mITT) Population
Description
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.
Time Frame
From Day 1 to Day 28
Secondary Outcome Measure Information:
Title
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Description
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.
Time Frame
From start of study intervention (Day 1) up to end of safety follow-up (Day 34)
Title
Number of Participants With AEs Leading to Discontinuation and Serious Adverse Events (SAEs)
Description
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.
Time Frame
From start of study intervention (Day 1) up to end of safety follow-up (Day 34)
Title
Percentage of Participants With Covid-19 Related Hospitalization or Death From Any Cause Through Day 28- Modified Intent-To-Treat 1 (mITT1) Population
Description
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.
Time Frame
From Day 1 to Day 28
Title
Time to Sustained Alleviation of All Targeted COVID-19 Signs and Symptoms Through Day 28- mITT Population
Description
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.
Time Frame
From Day 1 (baseline) to Day 28
Title
Time to Sustained Alleviation of All Targeted COVID-19 Signs and Symptoms Through Day 28- mITT1 Population
Description
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.
Time Frame
From Day 1 (baseline) to Day 28
Title
Time to Sustained Alleviation of All Targeted COVID-19 Signs and Symptoms Through Day 28- Modified Intent-to-Treat 2 (mITT2) Population
Description
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.
Time Frame
From Day 1 (baseline) to Day 28
Title
Percentage of Participants With Severe Covid-19 Signs and Symptoms Through Day 28- mITT Population
Description
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.
Time Frame
From Day 1 to Day 28
Title
Percentage of Participants With Severe Covid-19 Signs and Symptoms Through Day 28- mITT1 Population
Description
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.
Time Frame
From Day 1 to Day 28
Title
Percentage of Participants With Severe Covid-19 Signs and Symptoms Through Day 28- mITT2 Population
Description
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.
Time Frame
From Day 1 to Day 28
Title
Time to Sustained Resolution of All Targeted COVID-19 Signs and Symptoms Through Day 28- mITT Population
Description
Sustained resolution was defined as when all targeted symptoms were scored as absent for 4 consecutive days. Time to sustained resolution (event) was calculated as first event date minus first dose date plus 1, for 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.
Time Frame
From Day 1 (baseline) to Day 28
Title
Time to Sustained Resolution of All Targeted COVID-19 Signs and Symptoms Through Day 28- mITT1 Population
Description
Sustained resolution was defined as when all targeted symptoms were scored as absent for 4 consecutive days. Time to sustained resolution (event) was calculated as first event date minus first dose date plus 1, for 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.
Time Frame
From Day 1 (baseline) to Day 28
Title
Time to Sustained Resolution of All Targeted COVID-19 Signs and Symptoms Through Day 28- mITT2 Population
Description
Sustained resolution was defined as when all targeted symptoms were scored as absent for 4 consecutive days. Time to sustained resolution (event) was calculated as first event date minus first dose date plus 1, for 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.
Time Frame
From Day 1 (baseline) to Day 28
Title
Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT Population
Description
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.
Time Frame
From Day 1 (baseline) to Day 28
Title
Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population
Description
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.
Time Frame
From Day 1 (baseline) to Day 28
Title
Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population
Description
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.
Time Frame
From Day 1 (baseline) to Day 28
Title
Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT Population
Description
Sustained resolution was defined as when each targeted symptom was scored as absent for 4 consecutive days. Time to sustained resolution (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained resolution (censored), time was calculated as censoring date (last date on which symptom resolution was assessed) minus first dose date plus 1 or Day 25 whichever occurred first.
Time Frame
From Day 1 (baseline) to Day 28
Title
Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population
Description
Sustained resolution was defined as when each targeted symptom was scored as absent for 4 consecutive days. Time to sustained resolution (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained resolution (censored), time was calculated as censoring date (last date on which symptom resolution was assessed) minus first dose date plus 1 or Day 25 whichever occurred first.
Time Frame
From Day 1 (baseline) to Day 28
Title
Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population
Description
Sustained resolution was defined as when each targeted symptom was scored as absent for 4 consecutive days. Time to sustained resolution (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained resolution (censored), time was calculated as censoring date (last date on which symptom resolution was assessed) minus first dose date plus 1 or Day 25 whichever occurred first.
Time Frame
From Day 1 (baseline) to Day 28
Title
Number of Participants With Progression to a Worsening Status in 1 or More Self-reported COVID-19 Associated Symptoms Through Day 28-mITT Population
Description
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).
Time Frame
From Day 1 (baseline) to Day 28
Title
Number of Participants With Progression to a Worsening Status in 1 or More Self-reported COVID-19 Associated Symptoms Through Day 28-mITT1 Population
Description
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).
Time Frame
From Day 1 (baseline) to Day 28
Title
Number of Participants With Progression to a Worsening Status in 1 or More Self-reported COVID-19 Associated Symptoms Through Day 28-mITT2 Population
Description
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).
Time Frame
From Day 1 (baseline) to Day 28
Title
Percentage of Participants With a Resting Peripheral Oxygen Saturation >=95% at Days 1 and 5- mITT Population
Description
In this outcome measure, the percentage of participants with a resting peripheral oxygen saturation >=95% were reported.
Time Frame
Day 1, 5
Title
Percentage of Participants With a Resting Peripheral Oxygen Saturation >=95% at Days 1 and 5- mITT1 Population
Description
In this outcome measure, the percentage of participants with a resting peripheral oxygen saturation >=95% were reported.
Time Frame
Day 1, 5
Title
Percentage of Participants With a Resting Peripheral Oxygen Saturation >=95% at Days 1 and 5- mITT2 Population
Description
In this outcome measure, the percentage of participants with a resting peripheral oxygen saturation >=95% were reported.
Time Frame
Day 1, 5
Title
Percentage of Participants Who Died Through Week 24- mITT Population
Description
In this outcome measure, percentage of participants with death due to any cause was presented.
Time Frame
From Day 1 up to Week 24
Title
Percentage of Participants Who Died Through Week 24- mITT1 Population
Description
In this outcome measure, percentage of participants with death due to any cause was presented.
Time Frame
From Day 1 up to Week 24
Title
Percentage of Participants Who Died Through Week 24- mITT2 Population
Description
In this outcome measure, percentage of participants with death due to any cause was presented.
Time Frame
From Day 1 up to Week 24
Title
Plasma Concentration Versus Time Summary of PF-07321332
Time Frame
1 Hour post-dose on Day 1 and pre-dose on Day 5
Title
Change From Baseline in Logarithm to Base10 (Log10) Transformed Viral Load at Day 3, 5, 10 and 14- mITT Population
Description
The viral load was measured in nasal or nasopharyngeal samples using reverse transcription polymerase chain reaction (RT-PCR).
Time Frame
Baseline, Day 3, 5, 10 and 14
Title
Change From Baseline in Log10 Transformed Viral Load at Day 3, 5, 10 and 14- mITT1 Population
Description
The viral load was measured in nasal or nasopharyngeal samples using RT-PCR.
Time Frame
Baseline, Day 3, 5, 10 and 14
Title
Change From Baseline in Log10 Transformed Viral Load at Day 3, 5, 10 and 14- mITT2 Population
Description
The viral load was measured in nasal or nasopharyngeal samples using RT-PCR.
Time Frame
Baseline, Day 3, 5, 10 and 14
Title
Number of COVID-19 Related Medical Visits- mITT Population
Description
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.
Time Frame
From Day 1 up to Day 34
Title
Number of COVID-19 Related Medical Visits- mITT1 Population
Description
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.
Time Frame
From Day 1 up to Day 34
Title
Number of COVID-19 Related Medical Visits- mITT2 Population
Description
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.
Time Frame
From Day 1 up to Day 34
Title
Number of Days in Hospital and ICU for the Treatment of COVID-19- mITT Population
Time Frame
From Day 1 up to Day 34
Title
Number of Days in Hospital and ICU for the Treatment of COVID-19- mITT1 Population
Time Frame
From Day 1 up to Day 34
Title
Number of Days in Hospital and ICU for the Treatment of COVID-19- mITT2 Population
Time Frame
From Day 1 up to Day 34

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Cahaba Research Inc
City
Pelham
State/Province
Alabama
ZIP/Postal Code
35124
Country
United States
Facility Name
The Institute for Liver Health dba Arizona Clinical Trials
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85210
Country
United States
Facility Name
The Institute for Liver Health dba Arizona Clinical Trials
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Hope Clinical Research
City
Canoga Park
State/Province
California
ZIP/Postal Code
91303
Country
United States
Facility Name
Ascada Research
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Atella Clinical Research LLC.
City
La Palma
State/Province
California
ZIP/Postal Code
90623
Country
United States
Facility Name
Ark Clinical Research
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
American Institute of Research
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Facility Name
South Bay Clinical Research Institute
City
Redondo Beach
State/Province
California
ZIP/Postal Code
90277
Country
United States
Facility Name
Hope Clinical Research (COVID Satellite Site)
City
West Hills
State/Province
California
ZIP/Postal Code
91304
Country
United States
Facility Name
Future Innovative Treatments, LLC
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Xera Med Research
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33487
Country
United States
Facility Name
MOORE Clinical Research, Inc.
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
Innovative Research of West Florida, Inc.
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
Herco Medical and Research Center Inc
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Advance Clinical Research Group
City
Cutler Bay
State/Province
Florida
ZIP/Postal Code
33157
Country
United States
Facility Name
Beautiful Minds Clinical Research Center
City
Cutler Bay
State/Province
Florida
ZIP/Postal Code
33157
Country
United States
Facility Name
Unlimited Medical Research Group, LLC
City
Hialeah Gardens
State/Province
Florida
ZIP/Postal Code
33018
Country
United States
Facility Name
Qway Research
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33010
Country
United States
Facility Name
Eastern Research Inc
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33013
Country
United States
Facility Name
Inpatient Research Clinic
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33013
Country
United States
Facility Name
Doral Medical Research LLC.
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Doral Medical Research,LLC
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Advanced Pulmonary Research Institute
City
Loxahatchee Groves
State/Province
Florida
ZIP/Postal Code
33470
Country
United States
Facility Name
Savin Medical Group, LLC
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
Angels Clinical Research Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33122
Country
United States
Facility Name
LCC Medical Research Institute, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
Premium Medical Research Corp
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
Global Health Clinical Trials Corp
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Facility Name
South Florida Research Center, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Facility Name
Suncoast Research Group, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Facility Name
I.V.A.M. Clinical & Investigational Center, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
C'A Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33174
Country
United States
Facility Name
ProLive Medical Research, Corp.
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Facility Name
Entrust Clinical Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Reed Medical Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Kendall South Medical Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33185
Country
United States
Facility Name
Clinical Site Partners, Inc d/b/a CSP Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33186
Country
United States
Facility Name
Coral Research Clinic Corp
City
Miami
State/Province
Florida
ZIP/Postal Code
33186
Country
United States
Facility Name
Omega Research Orlando, LLC
City
Orlando
State/Province
Florida
ZIP/Postal Code
32808
Country
United States
Facility Name
NAPA Research LLC
City
Pompano Beach
State/Province
Florida
ZIP/Postal Code
33064
Country
United States
Facility Name
CDC Research Institute
City
Port Saint Lucie
State/Province
Florida
ZIP/Postal Code
34952
Country
United States
Facility Name
GCP, Global Clinical Professionals
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Facility Name
USPA Advance Concept Medical Research Group LLC
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Sunrise Research Institute
City
Sunrise
State/Province
Florida
ZIP/Postal Code
33325
Country
United States
Facility Name
Santos Research Center, CORP
City
Tampa
State/Province
Florida
ZIP/Postal Code
33615
Country
United States
Facility Name
Clinical Site Partners, Inc. dba CSP Orlando
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Research by Design, LLC
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60643
Country
United States
Facility Name
New Orleans Sinus Center (COVID-19 Testing)
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072
Country
United States
Facility Name
Tandem Clinical Research GI, LLC
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072
Country
United States
Facility Name
Mercury Street Medical Group, PLLC
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
Facility Name
Excel Clinical Research
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
Meridian Clinical Research, LLC
City
Endwell
State/Province
New York
ZIP/Postal Code
13760
Country
United States
Facility Name
Monroe Biomedical Research
City
Monroe
State/Province
North Carolina
ZIP/Postal Code
28112
Country
United States
Facility Name
Accellacare
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Premier Medical Group
City
Clarksville
State/Province
Tennessee
ZIP/Postal Code
37040
Country
United States
Facility Name
PharmaTex Research, LLC
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79109
Country
United States
Facility Name
ARC Clinical Research at William Cannon
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
St Hope Foundation
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Facility Name
Conroe Willis Medical Research
City
Conroe
State/Province
Texas
ZIP/Postal Code
77304
Country
United States
Facility Name
South Texas Clinical Research
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78413
Country
United States
Facility Name
SignatureCare Emergency Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77008
Country
United States
Facility Name
Trio Clinical Trials, LLC
City
Houston
State/Province
Texas
ZIP/Postal Code
77008
Country
United States
Facility Name
C & R Research Services USA
City
Houston
State/Province
Texas
ZIP/Postal Code
77022
Country
United States
Facility Name
Next Level Urgent Care
City
Houston
State/Province
Texas
ZIP/Postal Code
77057
Country
United States
Facility Name
SMS Clinical Research, LLC
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75149
Country
United States
Facility Name
SMS Clinical Research
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75149
Country
United States
Facility Name
LinQ Research, LLC
City
Pearland
State/Province
Texas
ZIP/Postal Code
77584
Country
United States
Facility Name
Epic Medical Research
City
Red Oak
State/Province
Texas
ZIP/Postal Code
75154
Country
United States
Facility Name
Sun Research Institute
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
BFHC Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78249
Country
United States
Facility Name
Tranquility Research
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Facility Name
TPMG (Tidewater Physicians Multispecialty Group) Clinical Research
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23606
Country
United States
Facility Name
Instituto de Investigaciones Clinicas Zarate
City
Zarate
State/Province
Buenos Aires
ZIP/Postal Code
B2800DGH
Country
Argentina
Facility Name
Hospital De Clínicas Presidente Dr.Nicolas Avellaneda
City
San Miguel de Tucuman
State/Province
Tucuman
ZIP/Postal Code
4000
Country
Argentina
Facility Name
Chronos Pesquisa Clinica
City
Brasilia
State/Province
Distrito Federal
ZIP/Postal Code
72145-450
Country
Brazil
Facility Name
Hospital Agamenon Magalhaes
City
Recife
State/Province
Pernambuco
ZIP/Postal Code
52051-380
Country
Brazil
Facility Name
CECIP JAÚ - Centro de Estudos Clínicos do Interior Paulista - LTDA
City
Jau
State/Province
SAO Paulo
ZIP/Postal Code
17201-130
Country
Brazil
Facility Name
Individual Practice for Primary Medical Care - IPPMC - Dr. P. Panayotov EOOD
City
Burgas
ZIP/Postal Code
8001
Country
Bulgaria
Facility Name
"Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases-Haskovo" Ltd
City
Haskovo
ZIP/Postal Code
6300
Country
Bulgaria
Facility Name
MHAT "Sv.Ivan. Rilski'' Kozloduy EOOD
City
Kozloduy
ZIP/Postal Code
3320
Country
Bulgaria
Facility Name
Diagnostic-Consultative Center I Lom EOOD
City
Lom
ZIP/Postal Code
3600
Country
Bulgaria
Facility Name
Multiprofile Hospital for Active Treatment- Sveti Nikolay Chudotvoretz EOOD
City
Lom
ZIP/Postal Code
3600
Country
Bulgaria
Facility Name
Medical centre Leo Clinic EOOD
City
Lovech
ZIP/Postal Code
5500
Country
Bulgaria
Facility Name
MHAT Heart and Brain EAD
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
DCC Sveti Georgi EOOD
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
Facility Name
MHAT "St. Panteleimon "- Plovdiv
City
Plovdiv
ZIP/Postal Code
4004
Country
Bulgaria
Facility Name
Multiprofile Hospital for Active Treatment Sveti Ivan Rilski - Razgrad AD
City
Razgrad
ZIP/Postal Code
7200
Country
Bulgaria
Facility Name
"Specialized Hospital for Active Treatment of Pneumo-Physiatric Diseases Dr. Dimitar Gramatikov -
City
Ruse
ZIP/Postal Code
7002
Country
Bulgaria
Facility Name
UMHAT Medica Ruse OOD
City
Ruse
ZIP/Postal Code
7013
Country
Bulgaria
Facility Name
Multiprofile Hospital for Active Treatment - Samokov EOOD
City
Samokov
ZIP/Postal Code
2000
Country
Bulgaria
Facility Name
Medical Center-1-Sevlievo EOOD
City
Sevlievo
ZIP/Postal Code
5400
Country
Bulgaria
Facility Name
Multiprofile Hospital For Active Treatment Shumen AD
City
Shumen
ZIP/Postal Code
9700
Country
Bulgaria
Facility Name
Multiprofile hospital for active treatment - Sliven to Military Medical Academy
City
Sliven
ZIP/Postal Code
8800
Country
Bulgaria
Facility Name
MHAT "Dr. Ivan Seliminski" AD, Sliven
City
Sliven
ZIP/Postal Code
8801
Country
Bulgaria
Facility Name
Diagnostic-Consultative Center XXII- Sofia ЕООD
City
Sofia
ZIP/Postal Code
1113
Country
Bulgaria
Facility Name
MHAT "St. Sofia" EOOD
City
Sofia
ZIP/Postal Code
1618
Country
Bulgaria
Facility Name
Specialized hospital for active treatment in pulmonology and phthisiology "Stara Zagora" EOOD
City
Stara Zagora
ZIP/Postal Code
6000
Country
Bulgaria
Facility Name
Multiprofile Hospital for Active Treatment Targovishte AD
City
Targovishte
ZIP/Postal Code
7700
Country
Bulgaria
Facility Name
Outpatient Clinic for Primary Outpatient Medical Care "Puls" - Dr. Mladen Buchvarov EOOD
City
Tsarevo
ZIP/Postal Code
8260
Country
Bulgaria
Facility Name
Medical center Leo Clinic EOOD
City
Varna
ZIP/Postal Code
9020
Country
Bulgaria
Facility Name
Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases Vratsa EOOD
City
Vratsa
ZIP/Postal Code
3000
Country
Bulgaria
Facility Name
Fundacion Cardiomet Cequin
City
Armenia
State/Province
Quindio
ZIP/Postal Code
630004
Country
Colombia
Facility Name
Zdraví-Fit, s.r.o.
City
Protivín
ZIP/Postal Code
398 11
Country
Czechia
Facility Name
Nemocnice Slany
City
Slany
ZIP/Postal Code
274 01
Country
Czechia
Facility Name
Trial Pharma Kft.
City
Bekescsaba
ZIP/Postal Code
5600
Country
Hungary
Facility Name
Debreceni Egyetem Klinikai Kozpont Infektologiai Klinika
City
Debrecen
ZIP/Postal Code
4031
Country
Hungary
Facility Name
Agria-Study Kft.
City
Eger
ZIP/Postal Code
3300
Country
Hungary
Facility Name
Trial Pharma Kft.
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
Facility Name
Medifarma-98 Kft.
City
Nyiregyhaza
ZIP/Postal Code
4400
Country
Hungary
Facility Name
AIIMS Raipur
City
Raipur
State/Province
Chhattisgarh
ZIP/Postal Code
492099
Country
India
Facility Name
Jupiter Hospital
City
Vadodara
State/Province
Gujarat
ZIP/Postal Code
390012
Country
India
Facility Name
BGS Global Institute of Medical Sciences and Hospital
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560060
Country
India
Facility Name
Lisie Hospital
City
Kochi
State/Province
Kerala
ZIP/Postal Code
682018
Country
India
Facility Name
Jehangir Clinical Development Centre Pvt. Ltd
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411001
Country
India
Facility Name
Lifepoint Research LLP
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411057
Country
India
Facility Name
Jawahar Lal Nehru Medical College
City
Ajmer
State/Province
Rajasthan
ZIP/Postal Code
305001
Country
India
Facility Name
Apex Hospitals Pvt Ltd
City
Jaipur
State/Province
Rajasthan
ZIP/Postal Code
302017
Country
India
Facility Name
Maharaja Agrasen Superspeciality Hospital
City
Jaipur
State/Province
Rajasthan
ZIP/Postal Code
302039
Country
India
Facility Name
Nil Ratan Sircar Medical College and Hospital
City
Kolkata
State/Province
WEST Bengal
ZIP/Postal Code
700014
Country
India
Facility Name
Aakash Healthcare Private Limited
City
New Delhi
ZIP/Postal Code
110075
Country
India
Facility Name
Sardar Patel Medical College
City
Pavan PURI Bikaner, Rajasthan
ZIP/Postal Code
334003
Country
India
Facility Name
International University of Health and Welfare Narita Hospital
City
Narita
State/Province
Chiba
ZIP/Postal Code
286-8520
Country
Japan
Facility Name
National Hokkaido Medical Center
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
063-0005
Country
Japan
Facility Name
Rinku General Medical Center
City
Izumisano
State/Province
Osaka
ZIP/Postal Code
598-8577
Country
Japan
Facility Name
Tokyo Medical University Hachioji Medical Center
City
Hachioji
State/Province
Tokyo
ZIP/Postal Code
1930998
Country
Japan
Facility Name
National Center for Global Health and Medicine
City
Shinjuku City
State/Province
Tokyo
ZIP/Postal Code
162-8655
Country
Japan
Facility Name
Kyungpook National University Chilgok Hospital
City
Daegu
ZIP/Postal Code
41404
Country
Korea, Republic of
Facility Name
Incheon Medical Center
City
Incheon
ZIP/Postal Code
22532
Country
Korea, Republic of
Facility Name
Chonnam National University Bitgoeul Hospital
City
Nam-gu
ZIP/Postal Code
61748
Country
Korea, Republic of
Facility Name
SMG-SNU Boramae Medical Center
City
Seoul
ZIP/Postal Code
07061
Country
Korea, Republic of
Facility Name
Hospital Umum Sarawak
City
Kuching
State/Province
Sarawak
ZIP/Postal Code
93586
Country
Malaysia
Facility Name
Hospital Miri
City
Miri
State/Province
Sarawak
ZIP/Postal Code
98000
Country
Malaysia
Facility Name
Clinical Research Institute Saltillo S.A. de C.V.
City
Saltillo
State/Province
Coahuila
ZIP/Postal Code
25020
Country
Mexico
Facility Name
Asociacion Mexicana para la Investigacion Clinica A.C. (AMIC)
City
Pachuca de Soto
State/Province
Hidalgo
ZIP/Postal Code
42070
Country
Mexico
Facility Name
Instituto Jalisciense de Metabolismo, S.C.
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44670
Country
Mexico
Facility Name
JM Research SC
City
Cuernavaca
State/Province
Morelos
ZIP/Postal Code
62290
Country
Mexico
Facility Name
Christus - Latam Hub Center of Excellence and Innovation Center S.C.
City
Monterrey
State/Province
Nuevo LEON
ZIP/Postal Code
64060
Country
Mexico
Facility Name
Eukarya Pharmasite S.C.
City
Monterrey
State/Province
Nuevo LEON
ZIP/Postal Code
64718
Country
Mexico
Facility Name
Oaxaca Site Management Organization
City
Oaxaca de Juarez
State/Province
Oaxaca
ZIP/Postal Code
68000
Country
Mexico
Facility Name
InfectoLab Consultorios de Especialidad en Infectologia
City
Baja California
State/Province
Tijuana
ZIP/Postal Code
22010
Country
Mexico
Facility Name
Kohler & Milstein Research S.A. de C.V.
City
Merida
State/Province
Yucatan
ZIP/Postal Code
97070
Country
Mexico
Facility Name
EME RED Hospitalaria
City
Mérida
State/Province
Yucatán
ZIP/Postal Code
97000
Country
Mexico
Facility Name
Centro de Investigacion Clinica Del Pacifico SA de CV
City
Acapulco
Country
Mexico
Facility Name
Hospital Cardiologica Aguascalientes
City
Aguascalientes
ZIP/Postal Code
CP 201230
Country
Mexico
Facility Name
Instituto de Investigaciones Clínicas para la Salud
City
Durango
ZIP/Postal Code
34000
Country
Mexico
Facility Name
FAICIC S. de R.L. de C.V.
City
Veracruz
ZIP/Postal Code
91900
Country
Mexico
Facility Name
Sociedad de Metabolismo y Corazon S.C.
City
Veracruz
ZIP/Postal Code
91900
Country
Mexico
Facility Name
Arké SMO S.A de C.V
City
Veracruz
ZIP/Postal Code
91910
Country
Mexico
Facility Name
KLIMED Marek Klimkiewicz
City
Bialystok
ZIP/Postal Code
15-704
Country
Poland
Facility Name
Centrum Badań Klinicznych Piotr Napora Lekarze Spółka Partnerska
City
Wroclaw
ZIP/Postal Code
51-162
Country
Poland
Facility Name
Clinical Research Management Group Inc
City
Ponce
ZIP/Postal Code
00780
Country
Puerto Rico
Facility Name
Advance Medical Research Center
City
San Juan
ZIP/Postal Code
00926
Country
Puerto Rico
Facility Name
LLC Trekhgorka Medicine
City
Odintsovo
State/Province
Moscow Region
ZIP/Postal Code
143005
Country
Russian Federation
Facility Name
Barnaul City Hospital Number 5
City
Barnaul
ZIP/Postal Code
656045
Country
Russian Federation
Facility Name
KDC "Evromedservis", OJSC
City
Moscow
ZIP/Postal Code
115419
Country
Russian Federation
Facility Name
Smolensk State Medical University
City
Smolensk
ZIP/Postal Code
214019
Country
Russian Federation
Facility Name
MERC Welkom
City
Welkom
State/Province
FREE State
ZIP/Postal Code
9460
Country
South Africa
Facility Name
East Rand Research Centre T/A Worthwhile Clinical Trials
City
Benoni
State/Province
Gauteng
ZIP/Postal Code
1500
Country
South Africa
Facility Name
Botho Ke Bontle Health Services
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0122
Country
South Africa
Facility Name
Synapta Clinical Research Center
City
Durban
State/Province
Kwazulu Natal
ZIP/Postal Code
4001
Country
South Africa
Facility Name
Limpopo Clinical Research Initiative
City
Thabazimbi
State/Province
Limpopo
ZIP/Postal Code
0380
Country
South Africa
Facility Name
MERC Middelburg
City
Middelburg
State/Province
Mpumalanga
ZIP/Postal Code
1055
Country
South Africa
Facility Name
Eba Centelles
City
Centelles
State/Province
Barcelona [barcelona]
ZIP/Postal Code
08540
Country
Spain
Facility Name
Complexo Hospitalario Universitario da Coruna
City
A Coruña
ZIP/Postal Code
15006
Country
Spain
Facility Name
Bangkok Centre Hotel
City
Bangrak
State/Province
Bangkok
ZIP/Postal Code
10500
Country
Thailand
Facility Name
Chula Field Hospital, Chulalongkorn University Sport center (Chantanayingyong Gymnasium)
City
Pathum Wan District,
State/Province
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Facility Name
Thai Red Cross Emerging Infectious Diseases (EDI) Clinic
City
Pathumwan,
State/Province
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Facility Name
The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT),
City
Pathumwan
State/Province
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Facility Name
Faculty of Medicine - Khon Kaen University
City
Muang
State/Province
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
Facility Name
Department of Internal Medicine, Faculty of Medicine, Prince of Songkla University,
City
Hat Yai
State/Province
Songkhla
ZIP/Postal Code
90110
Country
Thailand
Facility Name
Ankara University Medical Faculty, Ibni-Sina Hospital
City
Ankara
ZIP/Postal Code
06230
Country
Turkey
Facility Name
Hacettepe University Medical Faculty Hospital
City
Ankara
ZIP/Postal Code
06230
Country
Turkey
Facility Name
Akdeniz Universitesi Hastanesi
City
Antalya
ZIP/Postal Code
07059
Country
Turkey
Facility Name
Istanbul Medipol University Clinical Research Ethics Committee
City
Beykoz / Istanbul
ZIP/Postal Code
34810
Country
Turkey
Facility Name
Gaziantep University Medical Faculty
City
Gaziantep
ZIP/Postal Code
27300
Country
Turkey
Facility Name
Istanbul Yedikule Gogus Hastaliklari ve Gogus Cerrahisi Egitim Arastirma Hastanesi
City
Istanbul
ZIP/Postal Code
34020
Country
Turkey
Facility Name
Istanbul University Cerrahpasa-Cerrahpasa Medical Faculty
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Facility Name
Acibadem Saglik Hizmetleri ve Tic.A.S, Acibadem Atakent Hastanesi
City
Istanbul
ZIP/Postal Code
34303
Country
Turkey
Facility Name
Istanbul Universitesi Klinik Arastirmalar Mukemmeliyet Uygulama ve Arastirma Merkezi
City
Istanbul
ZIP/Postal Code
34452
Country
Turkey
Facility Name
Basaksehir Cam ve Sakura Sehir Hastanesi
City
Istanbul
ZIP/Postal Code
34480
Country
Turkey
Facility Name
Kocaeli University Medical Faculty
City
Kocaeli
ZIP/Postal Code
41380
Country
Turkey
Facility Name
Sbü Dr. Suat Seren Göğüs Hastaliklari Ve Cerrahisi Eğitim Ve Araştirma Hastanesi
City
Konak/Izmir
ZIP/Postal Code
35170
Country
Turkey
Facility Name
Mersin University Health Research and Application Hospital
City
Mersin
ZIP/Postal Code
33110
Country
Turkey
Facility Name
Sakarya University Training and Research Hospital
City
Sakarya
ZIP/Postal Code
54100
Country
Turkey
Facility Name
Karadeniz Teknik Universitesi Farabi Hastanesi
City
Trabzon
ZIP/Postal Code
61080
Country
Turkey
Facility Name
Communal non-profit enterprise "City Clinical Hospital #16" of Dnipro City Council
City
Dnipro
ZIP/Postal Code
49069
Country
Ukraine
Facility Name
Municipal Nonprofit Enterprise "Ivano-Frankivsk Regional Clinical Infectious Diseases Hospital of
City
Ivano-Frankivsk
ZIP/Postal Code
76007
Country
Ukraine
Facility Name
Communal nonprofit enterprise "Central City Clinical Hospital of Ivano-Frankivsk City Council"
City
Ivano-Frankivsk
ZIP/Postal Code
76018
Country
Ukraine
Facility Name
Municipal Nonprofit Enterprise "City Student Hospital" of Kharkiv City Council
City
Kharkiv
ZIP/Postal Code
61002
Country
Ukraine
Facility Name
Municipal Nonprofit Enterprise of Kharkiv Regional Council "Regional Clinical Infectious Diseases
City
Kharkiv
ZIP/Postal Code
61096
Country
Ukraine
Facility Name
"Municipal Non-Profit Enterprise "Alexander Clinical Hospital of Kyiv" of the Kyiv City Council
City
Kyiv
ZIP/Postal Code
01601
Country
Ukraine
Facility Name
Municipal non-commercial enterprise "Kyiv City Clinical Hospital #1" Of Executive Body Of the Kyiv
City
Kyiv
ZIP/Postal Code
02091
Country
Ukraine
Facility Name
Kyiv Railway Clinical Hospital No.2 of Branch "Health Center of the Public Joint Stock Company
City
Kyiv
ZIP/Postal Code
03049
Country
Ukraine
Facility Name
Polyclinic of Center for Medical Services and Rehabilitation of State Joint-Stock Holding Company
City
Kyiv
ZIP/Postal Code
04050
Country
Ukraine
Facility Name
Municipal NonProfit Enterprise of the Lviv Regional Council Lviv Regional Information and Analitical
City
Lviv
ZIP/Postal Code
79008
Country
Ukraine
Facility Name
Municipal Nonprofit Enterprise "Lviv City Clinic Hospital #4"
City
Lviv
ZIP/Postal Code
79011
Country
Ukraine
Facility Name
Municipal Enterprise "Poltava Regional Clinical Infectious Diseases Hospital" of Poltava Regional
City
Poltava
ZIP/Postal Code
36011
Country
Ukraine
Facility Name
Municipal Enterprise "Volyn Regional Clinical Hospital" of Volyn Regional Council
City
Tarasove Village
ZIP/Postal Code
45625
Country
Ukraine
Facility Name
Municipal Non-commercial Enterprise "Vinnytsia City Clinical Hospital №1"
City
Vinnytsia
ZIP/Postal Code
21029
Country
Ukraine
Facility Name
Communal Enterprise "Hospital #1" of Zhytomyr City Council
City
Zhytomyr
ZIP/Postal Code
10002
Country
Ukraine

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Citations:
PubMed Identifier
35172054
Citation
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.
Results Reference
derived
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=C4671005
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

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

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