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Evaluation of Protease Inhibition for COVID-19 in Standard-Risk Patients (EPIC-SR).

Primary Purpose

COVID-19

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
PF-07321332
Ritonavir
Placebo
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 SARS-CoV-2 Infection

Eligibility Criteria

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

Inclusion Criteria:

  • Confirmed SARS-CoV-2 infection 5 days prior to randomization
  • Initial onset of COVID-19 signs/symptoms within 5 days of randomization
  • Fertile participants must agree to use a highly effective method of contraception

Exclusion Criteria:

  • Has at least one underlying medical condition associated with an increased risk of developing severe illness from COVID-19
  • History of or need for hospitalization for the medical treatment of COVID-19
  • Prior diagnosis of SARS-CoV-2 infection (reinfection)
  • Known medical history of liver disease
  • Receiving dialysis or have known renal impairment
  • Known Human Immunodeficiency Virus (HIV) infection with viral load > 400 copies/ml or taking prohibited medications for HIV treatment
  • Suspected or confirmed concurrent active systemic infection other than COVID-19
  • Current or expected use of any medications or substances that are highly dependent on Cytochrome P450 3A4 (CYP3A4) for clearance or are strong inducers of CYP3A4
  • Has received or is expected to receive monoclonal antibody treatment or convalescent COVID-19 plasma
  • Has received any SARS-CoV-2 vaccine within 12 months of screening
  • Participating in another interventional clinical study with an investigational compound or device, including those for COVID-19
  • Known prior participation in this trial or other trial involving PF-07321332
  • Oxygen saturation of < 92% on room air
  • Females who are pregnant or breastfeeding

Sites / Locations

  • Cahaba Research Inc
  • The Institute for Liver Health dba Arizona Clinical Trials
  • Matrix Mobile Health Clinic #49, #35, and #62
  • The Institute for Liver Health dba Arizona Clinical Trials
  • Hope Clinical Research
  • Lightship
  • Ascada Research
  • Atella Clinical Research LLC.
  • Ark Clinical Research
  • South Bay Clinical Research Institute
  • Benchmark Research
  • Optimus Medical Group
  • Hope Clinical Research (COVID Satellite Site)
  • Future Innovative Treatments, LLC
  • Synergy Healthcare
  • MOORE Clinical Research, Inc.
  • TrueBlue Clinical Research
  • Herco Medical and Research Center Inc
  • Advance Clinical Research Group
  • Beautiful Minds Clinical Research Center
  • Omega Research Orlando, LLC
  • Unlimited Medical Research Group, LLC
  • Eastern Research Inc
  • Inpatient Research Clinic
  • Doral Medical Research, LLC
  • ASCLEPES Research Centers
  • Pro-Care Research Center, Corp.
  • 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.
  • 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, Inc.
  • Clinical Site Partners, Inc d/b/a CSP Miami
  • Coral Research Clinic Corp
  • Omega Research Orlando, LLC
  • CDC Research Institute
  • GCP, Global Clinical Professionals
  • USPA Advance Concept Medical Research Group LLC
  • ASCLEPES Research Centers
  • Sunrise Research Institute
  • Santos Research Center, CORP
  • Clinical Site Partners, Inc. dba CSP Orlando
  • Accellacare
  • McFarland Clinic, PC
  • New Orleans Sinus Center (COVID-19 Testing)
  • Tandem Clinical Research GI, LLC
  • Southern Clinical Research Associates, LLC
  • Mercury Street Medical Group, PLLC
  • Excel Clinical research
  • AXCES Research Group
  • NYC Health + Hospitals / Harlem
  • Monroe Biomedical Research
  • Accellacare
  • Innovo Research: Wilmington Health
  • Avera McKennan Hospital & University Health Center
  • Avera Research Institute
  • 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
  • Next Level Urgent Care
  • LinQ Research, LLC
  • Epic Medical Research
  • Endeavor Clinical Trials, LLC
  • BFHC Research
  • Tranquility Research
  • TMPG Clinical Research
  • TPMG Clinical Research
  • Instituto de Investigaciones Clinicas Zarate
  • Instituto Médico de la Fundación Estudios Clínicos (Fundación Estudios Clínicos)
  • Hospital de Clinicas Presidente Nicolas Avellaneda
  • Clinica Mayo Urgencias Medicas Cruz Blanca SRL
  • Hospital Privado Centro Médico de Córdoba
  • Chronos Pesquisa Clinica
  • Hospital Agamenon Magalhaes
  • Centro de Estudos e Pesquisas em Moléstias Infecciosas
  • Hospital De Clinicas De Porto Alegre
  • IBPClin - Instituto Brasil de Pesquisa Clínica
  • Instituto Nacional de Infectologia Evandro Chagas - INI/FIOCRUZ
  • CECOR - Centro Oncológico de Roraima
  • CECIP JAÚ - Centro de Estudos Clínicos do Interior Paulista - LTDA
  • Hospital Dia do Pulmao
  • Hospital e Maternidade Celso Pierro - PUC Campinas / Sociedade Campineira de Educação e Instruçã
  • Hospital Alemão Oswaldo Cruz
  • Unidade Referenciada Oswaldo Cruz Vergueiro
  • Clinica de Alergia Martti Antila
  • CEMEC - Centro Multidisciplinar de Estudos Clínicos
  • Instituto de Infectologia Emilio Ribas
  • 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 -
  • Multiprofile Hospital for Active Treatment - Samokov EOOD
  • Medical Center-1-Sevlievo EOOD
  • Multiprofile hospital for active treatment - Sliven to Military Medical Academy
  • Diagnostic-Consultative Center XXII- Sofia ЕООD
  • UMHATEM N. I. Pirogov EAD
  • 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
  • MOBAL "D-r Stefan Cherkezov" AD
  • Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases Vratsa EOOD
  • Fundacion Centro de Investigacion Clinica CIC
  • Centro de Investigacion en Reumatologia y Especialidades Medicas S.A.S, CIREEM S.A.S
  • Fundacion Cardiomet Cequin
  • Zdraví-Fit, s.r.o.
  • Nemocnice Slany
  • Trial Pharma Kft.
  • Semmelweis University Varosmajori Sziv Es Ergyogyaszati Klinika
  • Varosmajori Sziv- es Ergyogyaszati Klinika
  • Debreceni Egyetem Klinikai Kozpont Infektologiai Klinika
  • Agria-Study Kft.
  • Trial Pharma Kft.
  • Medifarma-98 Kft.
  • International University of Health and Welfare Narita Hospital
  • Rakuwakai Otowa Hospital
  • Tokyo Shinagawa Hospital
  • Sekino Hospital
  • Kyushu Medical Center
  • Chonnam National University Bitgoeul Hospital
  • Boramae Medical Center
  • SMG-SNU Boramae Medical Center
  • Hospital Raja Perempuan Zainab II
  • Hospital Taiping
  • Hospital Miri
  • Klinik Kesihatan Kuang
  • Clinical Research Institute S.C.
  • Asociación Mexicana para la Investigación Clínica A.C.
  • JM Research SC
  • Christus - Latam Hub Center of Excellence and Innovation Center S.C.
  • Eukarya Pharmasite S.C.
  • Oaxaca Site Management Organization
  • Kohler & Milstein Research S.A. De C.V.
  • EME RED Hospitalaria
  • Instituto de Investigaciones Clínicas para la Salud
  • FAICIC Clinical Research
  • Sociedad de Metabolismo y Corazon S.C.
  • KLIMED Marek Klimkiewicz
  • Tomasz Blicharski Lubelskie Centrum Diagnostyczne
  • WIP Warsaw IBD Point Profesor Kierkus
  • Centrum Badań Klinicznych Piotr Napora Lekarze Spółka Partnerska
  • Clinical Research Management Group Inc
  • Advance Medical Research Center
  • Delta Health Care srl
  • HODOSI - MED, s.r.o.
  • MUDr. Viliam Cibik, PhD., s.r.o.
  • Plucna ambulancia Hrebenar, s.r.o.
  • ALERGIA s.r.o.
  • Global Clinical Trials
  • Worthwhile Clinical Trials
  • Reimed Vosloorus
  • Lenasia Clinical Trial Centre
  • Botho Ke Bontle Health Services
  • Clinical Trial Systems (Pty) Ltd
  • Sandton Medical Clinic
  • FCRN Clinical Trial Centre
  • Dr PJ Sebastian Clinical Research Centre
  • Synapta Clinical Research Center
  • Ahmed Al-Kadi Private Hospital
  • TASK Eden
  • Be Part Research Pty (Ltd)
  • Eba Centelles
  • Hospital Universitari Germans Trias i Pujol
  • Hospital Alvaro Cunqueiro
  • IMED Valencia
  • Complexo Hospitalario Universitario da Coruna
  • Complexo Hospitalario Universitario da Coruna
  • Hospital Universitario de la Paz
  • Hospital Universitario Virgen de Valme
  • Siriraj Hospital, Mahidol University
  • Riverside Bangkok Hotel
  • Bangkok Centre Hotel
  • Thai Red Cross Emerging Infectious Diseases (EDI) Clinic
  • The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT),
  • Baiyoke Suite Hotel
  • Department of Internal Medicine, Faculty of Medicine, Prince of Songkla University,
  • Khon Kaen Univerisity Field Hospital, Student Dormitory 26, Khon Kaen University
  • Srinagarind Hospital
  • Cukurova University Medical Faculty
  • Ankara University Medical Faculty, Ibni-Sina Hospital
  • Hacettepe University Medical Faculty Hospital
  • Akdeniz Universitesi Hastanesi
  • Gaziantep Universitesi Tip Fakultesi Sahinbey Uygulama ve Arastirma Hastanesi
  • Istanbul University Istanbul Medical Faculty
  • Istanbul University Cerrahpasa-Cerrahpasa Medical Faculty
  • Medipol Mega University Hospital
  • Acibadem University Atakent Hospital
  • Basaksehir Cam ve Sakura Sehir Hastanesi
  • Izmir Suat Seren Chest Disease and Surgery Training and Research Hospital
  • Kocaeli University Medical Faculty
  • Mersin University Medical Faculty
  • Sakarya University Training and Research Hospital
  • Karadeniz Teknik Universitesi Farabi Hastanesi
  • Regional Communal Nonprofit Institution "Chernivtsi Regional Clinical Hospital"
  • Communal non-commercial Enterprise "City Clinical Hospital №3" of Chernivtsi City Council
  • Municipal Nonprofit Enterprise "Ivano-Frankivsk Regional Clinical Infectious Diseases Hospital of
  • Municipal Non-profit Enterprise "Ivano-Frankivsk Regional Phthisiopulmonology Center of
  • Communal nonprofit enterprise "Central City Clinical Hospital of Ivano-Frankivsk City Council"
  • Municipal Nonprofit Enterprise of Kharkiv Regional Council "Regional Clinical Infectious Diseases
  • Municipal Non-profit Enterprise "Oleksandrivska Kyiv City Clinical Hospital" Of Executive Body Of
  • 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 "Lviv City Clinic Hospital #4"
  • Municipal Enterprise "Poltava Regional Clinical Infectious Diseases Hospital" of Poltava Regional
  • 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

Time to Sustained Alleviation of Overall COVID-19 Signs and Symptoms Through Day 28
Sustained alleviation of 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. Missing severity at baseline was considered as mild. Time to sustained alleviation of all targeted COVID-19 signs and symptoms through Day 28, was calculated as time (days) from start of study intervention or placebo (Day 1) until sustained alleviation of all targeted COVID-19 associated signs and symptoms. In this outcome measure time to sustained alleviation is reported consolidated for overall COVID-19 signs and symptoms.

Secondary Outcome Measures

Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious AEs and AEs Leading to Study and Study Drug Discontinuation
An AE was defined as any untoward medical occurrence in a participant or clinical study participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening ; required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity ; congenital anomaly/birth defect; or that was considered as an important medical event. TEAEs were defined as events that started on or after the study medication start date and time. AEs included both serious and all non-serious adverse events. AEs that led to study discontinuation and AEs that led to discontinuation of study intervention and then continued study were also reported in this outcome measure.
Percentage of Participants With COVID-19 Related Hospitalization or Death From Any Cause Through Day 28
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.
Percentage of Participants With Death Through Week 24
Percentage of participants with death (all-cause) event were reported in this outcome measure.
Number of COVID-19 Related Medical Visits Per Day Through Day 28
Number of COVID-19 related medical visits per day were reported in this outcome measure.
Duration of Hospitalization and Intensive Care Unit (ICU) Stay Through Day 28
Percentage of Participants With Severe Signs and Symptoms of COVID-19 Through Day 28
Participants recorded a daily severity rating of their symptom severity over the past 24 hours based on a 4-point scale in which 0 was reported if no symptoms were present; 1 if mild; 2 if moderate; and 3 if severe. A participant with severe score for any targeted symptoms post-baseline was counted as severe. Vomiting and diarrhea each was rated on a 4-point frequency scale where 0 was reported for no occurrence, 1 for 1 to 2 times, 2 for 3 to 4 times, and 3 for 5 or greater. Sense of smell and sense of taste each be rated on a 3-point Likert scale where 0 was reported if the sense of smell/taste was the same as usual, 1 if the sense of smell/taste was less than usual, and 2 for no sense of smell/taste.
Time to Sustained Resolution of Overall COVID-19 Signs and Symptoms Through Day 28
Sustained resolution was defined as when targeted symptoms are scored as absent for 4 consecutive days. The first day of the 4 consecutive-day period was considered the first event date.
Time to Sustained Alleviation of Each COVID-19 Signs and Symptoms Through Day 28
Sustained alleviation of 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. Missing severity at baseline was treated as mild. Time to sustained alleviation of all targeted COVID-19 signs and symptoms through Day 28, was calculated as time (days) from start of study intervention or placebo (Day 1) until sustained alleviation of all targeted COVID-19 associated signs and symptoms. In this outcome measure time to sustained alleviation is reported for each COVID-19 signs and symptoms.
Time to Sustained Resolution of Each COVID-19 Signs and Symptoms Through Day 28
Sustained resolution was defined as when targeted symptoms are scored as absent for 4 consecutive days. The first day of the 4 consecutive-day period was considered the first event date. In this outcome measure time to sustained resolution is reported consolidated for each COVID-19 signs and symptoms.
Percentage of Participants With Progression to Worsening Status of COVID-19 Signs and Symptoms
Participants recorded a daily severity rating of their symptom severity over the past 24 hours based on a 4-point scale in which 0 was reported if no symptoms were present; 1 if mild; 2 if moderate; and 3 if severe. Vomiting and diarrhea was rated on a 4-point frequency scale where 0 is reported for 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 Resting Peripheral Oxygen Saturation Greater Than or Equal to (>=) 95% at Day 1 and Day 5
Percentage of participants with a resting peripheral oxygen saturation >=95% were reported in this outcome measure.
Plasma Concentration Versus Time Summary of PF-07321332
Change From Baseline in Logarithm to Base10 (Log10) Transformed Viral Load at Days 3, 5, 10 and 14
Nasal samples were collected to estimate the viral load in participants in terms of logarithm to base 10 (log10) copies per milliliter.

Full Information

First Posted
July 30, 2021
Last Updated
July 20, 2023
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT05011513
Brief Title
Evaluation of Protease Inhibition for COVID-19 in Standard-Risk Patients (EPIC-SR).
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 LOW RISK OF PROGRESSING TO SEVERE ILLNESS
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Terminated
Why Stopped
Enrollment ceased due to a very low rate of hospitalization or death observed in the standard-risk patient population
Study Start Date
August 25, 2021 (Actual)
Primary Completion Date
July 25, 2022 (Actual)
Study Completion Date
July 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 primary hypothesis to be tested is whether or not there is a difference in time to sustained alleviation of all targeted COVID-19 signs and symptoms through Day 28 between PF-07321332/ritonavir and placebo.
Detailed Description
Throughout the study period, provision will be made to allow study visits to be conducted at a participant's home or at 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
SARS-CoV-2 Infection

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
Masking Description
Double-blind
Allocation
Randomized
Enrollment
1440 (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)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo (capsule)
Primary Outcome Measure Information:
Title
Time to Sustained Alleviation of Overall COVID-19 Signs and Symptoms Through Day 28
Description
Sustained alleviation of 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. Missing severity at baseline was considered as mild. Time to sustained alleviation of all targeted COVID-19 signs and symptoms through Day 28, was calculated as time (days) from start of study intervention or placebo (Day 1) until sustained alleviation of all targeted COVID-19 associated signs and symptoms. In this outcome measure time to sustained alleviation is reported consolidated for overall COVID-19 signs and symptoms.
Time Frame
From Day 1 to Day 28
Secondary Outcome Measure Information:
Title
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious AEs and AEs Leading to Study and Study Drug Discontinuation
Description
An AE was defined as any untoward medical occurrence in a participant or clinical study participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening ; required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity ; congenital anomaly/birth defect; or that was considered as an important medical event. TEAEs were defined as events that started on or after the study medication start date and time. AEs included both serious and all non-serious adverse events. AEs that led to study discontinuation and AEs that led to discontinuation of study intervention and then continued study were also reported in this outcome measure.
Time Frame
From start of study intervention (Day 1) up to Day 34
Title
Percentage of Participants With COVID-19 Related Hospitalization or Death From Any Cause Through Day 28
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.
Time Frame
From Day 1 to Day 28
Title
Percentage of Participants With Death Through Week 24
Description
Percentage of participants with death (all-cause) event were reported in this outcome measure.
Time Frame
From Day 1 to Week 24
Title
Number of COVID-19 Related Medical Visits Per Day Through Day 28
Description
Number of COVID-19 related medical visits per day were reported in this outcome measure.
Time Frame
From Day 1 to Day 28
Title
Duration of Hospitalization and Intensive Care Unit (ICU) Stay Through Day 28
Time Frame
From Day 1 to Day 28
Title
Percentage of Participants With Severe Signs and Symptoms of COVID-19 Through Day 28
Description
Participants recorded a daily severity rating of their symptom severity over the past 24 hours based on a 4-point scale in which 0 was reported if no symptoms were present; 1 if mild; 2 if moderate; and 3 if severe. A participant with severe score for any targeted symptoms post-baseline was counted as severe. Vomiting and diarrhea each was rated on a 4-point frequency scale where 0 was reported for no occurrence, 1 for 1 to 2 times, 2 for 3 to 4 times, and 3 for 5 or greater. Sense of smell and sense of taste each be rated on a 3-point Likert scale where 0 was reported if the sense of smell/taste was the same as usual, 1 if the sense of smell/taste was less than usual, and 2 for no sense of smell/taste.
Time Frame
From Day 1 to Day 28
Title
Time to Sustained Resolution of Overall COVID-19 Signs and Symptoms Through Day 28
Description
Sustained resolution was defined as when targeted symptoms are scored as absent for 4 consecutive days. The first day of the 4 consecutive-day period was considered the first event date.
Time Frame
From Day 1 to Day 28
Title
Time to Sustained Alleviation of Each COVID-19 Signs and Symptoms Through Day 28
Description
Sustained alleviation of 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. Missing severity at baseline was treated as mild. Time to sustained alleviation of all targeted COVID-19 signs and symptoms through Day 28, was calculated as time (days) from start of study intervention or placebo (Day 1) until sustained alleviation of all targeted COVID-19 associated signs and symptoms. In this outcome measure time to sustained alleviation is reported for each COVID-19 signs and symptoms.
Time Frame
From Day 1 to Day 28
Title
Time to Sustained Resolution of Each COVID-19 Signs and Symptoms Through Day 28
Description
Sustained resolution was defined as when targeted symptoms are scored as absent for 4 consecutive days. The first day of the 4 consecutive-day period was considered the first event date. In this outcome measure time to sustained resolution is reported consolidated for each COVID-19 signs and symptoms.
Time Frame
From Day 1 to Day 28
Title
Percentage of Participants With Progression to Worsening Status of COVID-19 Signs and Symptoms
Description
Participants recorded a daily severity rating of their symptom severity over the past 24 hours based on a 4-point scale in which 0 was reported if no symptoms were present; 1 if mild; 2 if moderate; and 3 if severe. Vomiting and diarrhea was rated on a 4-point frequency scale where 0 is reported for 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 to Day 28
Title
Percentage of Participants With Resting Peripheral Oxygen Saturation Greater Than or Equal to (>=) 95% at Day 1 and Day 5
Description
Percentage of participants with a resting peripheral oxygen saturation >=95% were reported in this outcome measure.
Time Frame
Day 1 and Day 5
Title
Plasma Concentration Versus Time Summary of PF-07321332
Time Frame
Day 1: 1 hour post dose; Day 5: 0 minutes pre-dose
Title
Change From Baseline in Logarithm to Base10 (Log10) Transformed Viral Load at Days 3, 5, 10 and 14
Description
Nasal samples were collected to estimate the viral load in participants in terms of logarithm to base 10 (log10) copies per milliliter.
Time Frame
Baseline, Days 3, 5, 10 and 14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Confirmed SARS-CoV-2 infection 5 days prior to randomization Initial onset of COVID-19 signs/symptoms within 5 days of randomization Fertile participants must agree to use a highly effective method of contraception Exclusion Criteria: Has at least one underlying medical condition associated with an increased risk of developing severe illness from COVID-19 History of or need for hospitalization for the medical treatment of COVID-19 Prior diagnosis of SARS-CoV-2 infection (reinfection) Known medical history of liver disease Receiving dialysis or have known renal impairment Known Human Immunodeficiency Virus (HIV) infection with viral load > 400 copies/ml or taking prohibited medications for HIV treatment Suspected or confirmed concurrent active systemic infection other than COVID-19 Current or expected use of any medications or substances that are highly dependent on Cytochrome P450 3A4 (CYP3A4) for clearance or are strong inducers of CYP3A4 Has received or is expected to receive monoclonal antibody treatment or convalescent COVID-19 plasma Has received any SARS-CoV-2 vaccine within 12 months of screening Participating in another interventional clinical study with an investigational compound or device, including those for COVID-19 Known prior participation in this trial or other trial involving PF-07321332 Oxygen saturation of < 92% on room air 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
Matrix Mobile Health Clinic #49, #35, and #62
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
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
Lightship
City
El Segundo
State/Province
California
ZIP/Postal Code
90245
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
South Bay Clinical Research Institute
City
Redondo Beach
State/Province
California
ZIP/Postal Code
90277
Country
United States
Facility Name
Benchmark Research
City
Sacramento
State/Province
California
ZIP/Postal Code
95864
Country
United States
Facility Name
Optimus Medical Group
City
San Francisco
State/Province
California
ZIP/Postal Code
94102
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
Synergy Healthcare
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34208
Country
United States
Facility Name
MOORE Clinical Research, Inc.
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
TrueBlue Clinical Research
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
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
Omega Research Orlando, LLC
City
DeBary
State/Province
Florida
ZIP/Postal Code
32713
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
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
ASCLEPES Research Centers
City
Lutz
State/Province
Florida
ZIP/Postal Code
33549
Country
United States
Facility Name
Pro-Care Research Center, Corp.
City
Miami Gardens
State/Province
Florida
ZIP/Postal Code
33014
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
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, Inc.
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
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
ASCLEPES Research Centers
City
Spring Hill
State/Province
Florida
ZIP/Postal Code
34609
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
Accellacare
City
Ames
State/Province
Iowa
ZIP/Postal Code
50010
Country
United States
Facility Name
McFarland Clinic, PC
City
Ames
State/Province
Iowa
ZIP/Postal Code
50010
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
Southern Clinical Research Associates, LLC
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70001
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
AXCES Research Group
City
Santa Fe
State/Province
New Mexico
ZIP/Postal Code
87505
Country
United States
Facility Name
NYC Health + Hospitals / Harlem
City
New York
State/Province
New York
ZIP/Postal Code
10037
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
Innovo Research: Wilmington Health
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Avera McKennan Hospital & University Health Center
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Facility Name
Avera Research Institute
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57108
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
Next Level Urgent Care
City
Houston
State/Province
Texas
ZIP/Postal Code
77057
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
Endeavor Clinical Trials, LLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
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
TMPG Clinical Research
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23606
Country
United States
Facility Name
TPMG 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
Instituto Médico de la Fundación Estudios Clínicos (Fundación Estudios Clínicos)
City
Rosario
State/Province
Santa FE
ZIP/Postal Code
2000
Country
Argentina
Facility Name
Hospital de Clinicas Presidente Nicolas Avellaneda
City
San Miguel de Tucuman
State/Province
Tucuman
ZIP/Postal Code
4000
Country
Argentina
Facility Name
Clinica Mayo Urgencias Medicas Cruz Blanca SRL
City
San Miguel de Tucuman
State/Province
Tucuman
ZIP/Postal Code
T4000IHE
Country
Argentina
Facility Name
Hospital Privado Centro Médico de Córdoba
City
Córdoba
ZIP/Postal Code
X5016KEH
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
Centro de Estudos e Pesquisas em Moléstias Infecciosas
City
Natal
State/Province
RIO Grande DO Norte
ZIP/Postal Code
59025-050
Country
Brazil
Facility Name
Hospital De Clinicas De Porto Alegre
City
Porto Alegre
State/Province
RIO Grande DO SUL
ZIP/Postal Code
90035-903
Country
Brazil
Facility Name
IBPClin - Instituto Brasil de Pesquisa Clínica
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
20241-180
Country
Brazil
Facility Name
Instituto Nacional de Infectologia Evandro Chagas - INI/FIOCRUZ
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
21040-360
Country
Brazil
Facility Name
CECOR - Centro Oncológico de Roraima
City
Boa Vista
State/Province
Roraima/rr
ZIP/Postal Code
69304-015
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
Hospital Dia do Pulmao
City
Blumenau
State/Province
SC
ZIP/Postal Code
89030-101
Country
Brazil
Facility Name
Hospital e Maternidade Celso Pierro - PUC Campinas / Sociedade Campineira de Educação e Instruçã
City
Campinas
State/Province
SP
ZIP/Postal Code
13060-904
Country
Brazil
Facility Name
Hospital Alemão Oswaldo Cruz
City
São Paulo
State/Province
SP
ZIP/Postal Code
01327-001
Country
Brazil
Facility Name
Unidade Referenciada Oswaldo Cruz Vergueiro
City
São Paulo
State/Province
SP
ZIP/Postal Code
01508-000
Country
Brazil
Facility Name
Clinica de Alergia Martti Antila
City
Sorocaba
State/Province
SÃO Paulo
ZIP/Postal Code
18040-425
Country
Brazil
Facility Name
CEMEC - Centro Multidisciplinar de Estudos Clínicos
City
São Bernardo do Campo
State/Province
SÃO Paulo
ZIP/Postal Code
09715-090
Country
Brazil
Facility Name
Instituto de Infectologia Emilio Ribas
City
São Paulo
ZIP/Postal Code
01246-900
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
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 - Sliven to Military Medical Academy
City
Sliven
ZIP/Postal Code
8800
Country
Bulgaria
Facility Name
Diagnostic-Consultative Center XXII- Sofia ЕООD
City
Sofia
ZIP/Postal Code
1113
Country
Bulgaria
Facility Name
UMHATEM N. I. Pirogov EAD
City
Sofia
ZIP/Postal Code
1606
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
MOBAL "D-r Stefan Cherkezov" AD
City
Veliko Tarnovo
ZIP/Postal Code
5002
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 Centro de Investigacion Clinica CIC
City
Medellin
State/Province
Antioquia
ZIP/Postal Code
050021
Country
Colombia
Facility Name
Centro de Investigacion en Reumatologia y Especialidades Medicas S.A.S, CIREEM S.A.S
City
Bogota
State/Province
Cundinamarca
ZIP/Postal Code
110221
Country
Colombia
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
Semmelweis University Varosmajori Sziv Es Ergyogyaszati Klinika
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
Varosmajori Sziv- es Ergyogyaszati Klinika
City
Budapest
ZIP/Postal Code
1122
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
International University of Health and Welfare Narita Hospital
City
Narita
State/Province
Chiba
ZIP/Postal Code
286-8520
Country
Japan
Facility Name
Rakuwakai Otowa Hospital
City
Kyoto-shi
State/Province
Kyoto
ZIP/Postal Code
607-8062
Country
Japan
Facility Name
Tokyo Shinagawa Hospital
City
Shinagawa-ku
State/Province
Tokyo
ZIP/Postal Code
140-8522
Country
Japan
Facility Name
Sekino Hospital
City
Toshimaku
State/Province
Tokyo
ZIP/Postal Code
171-0014
Country
Japan
Facility Name
Kyushu Medical Center
City
Fukuoka
ZIP/Postal Code
810-8563
Country
Japan
Facility Name
Chonnam National University Bitgoeul Hospital
City
Gwangju
ZIP/Postal Code
61748
Country
Korea, Republic of
Facility Name
Boramae Medical Center
City
Seoul
ZIP/Postal Code
07061
Country
Korea, Republic of
Facility Name
SMG-SNU Boramae Medical Center
City
Seoul
ZIP/Postal Code
07061
Country
Korea, Republic of
Facility Name
Hospital Raja Perempuan Zainab II
City
Kota Bharu
State/Province
Kelantan
ZIP/Postal Code
15586
Country
Malaysia
Facility Name
Hospital Taiping
City
Taiping
State/Province
Perak
ZIP/Postal Code
34000
Country
Malaysia
Facility Name
Hospital Miri
City
Miri
State/Province
Sarawak
ZIP/Postal Code
98000
Country
Malaysia
Facility Name
Klinik Kesihatan Kuang
City
Rawang
State/Province
Selangor
ZIP/Postal Code
48050
Country
Malaysia
Facility Name
Clinical Research Institute S.C.
City
Saltillo
State/Province
Coahuila
ZIP/Postal Code
25020
Country
Mexico
Facility Name
Asociación Mexicana para la Investigación Clínica A.C.
City
Pachuca de Soto
State/Province
Hidalgo
ZIP/Postal Code
42070
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
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
Instituto de Investigaciones Clínicas para la Salud
City
Durango
ZIP/Postal Code
34000
Country
Mexico
Facility Name
FAICIC Clinical Research
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
KLIMED Marek Klimkiewicz
City
Bialystok
ZIP/Postal Code
15-704
Country
Poland
Facility Name
Tomasz Blicharski Lubelskie Centrum Diagnostyczne
City
Swidnik
ZIP/Postal Code
21-040
Country
Poland
Facility Name
WIP Warsaw IBD Point Profesor Kierkus
City
Warszawa
ZIP/Postal Code
00-728
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
Delta Health Care srl
City
Bucuresti
ZIP/Postal Code
014142
Country
Romania
Facility Name
HODOSI - MED, s.r.o.
City
Moldava nad Bodvou
ZIP/Postal Code
04501
Country
Slovakia
Facility Name
MUDr. Viliam Cibik, PhD., s.r.o.
City
Pruske
ZIP/Postal Code
018 52
Country
Slovakia
Facility Name
Plucna ambulancia Hrebenar, s.r.o.
City
Spisska Nova Ves
ZIP/Postal Code
052 01
Country
Slovakia
Facility Name
ALERGIA s.r.o.
City
Topolcany
ZIP/Postal Code
955 01
Country
Slovakia
Facility Name
Global Clinical Trials
City
Gqeberha
State/Province
Eastern CAPE
ZIP/Postal Code
6014
Country
South Africa
Facility Name
Worthwhile Clinical Trials
City
Benoni
State/Province
Gauteng
ZIP/Postal Code
1500
Country
South Africa
Facility Name
Reimed Vosloorus
City
Boksburg
State/Province
Gauteng
ZIP/Postal Code
1475
Country
South Africa
Facility Name
Lenasia Clinical Trial Centre
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
1820
Country
South Africa
Facility Name
Botho Ke Bontle Health Services
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0184
Country
South Africa
Facility Name
Clinical Trial Systems (Pty) Ltd
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0186
Country
South Africa
Facility Name
Sandton Medical Clinic
City
Sandton
State/Province
Gauteng
ZIP/Postal Code
2196
Country
South Africa
Facility Name
FCRN Clinical Trial Centre
City
Vereeniging
State/Province
Gauteng
ZIP/Postal Code
1935
Country
South Africa
Facility Name
Dr PJ Sebastian Clinical Research Centre
City
Durban
State/Province
Kwa-zulu Natal
ZIP/Postal Code
4092
Country
South Africa
Facility Name
Synapta Clinical Research Center
City
Durban
State/Province
Kwazulu Natal
ZIP/Postal Code
4001
Country
South Africa
Facility Name
Ahmed Al-Kadi Private Hospital
City
Mayville, Durban
State/Province
Kwazulu-natal
ZIP/Postal Code
4091
Country
South Africa
Facility Name
TASK Eden
City
George
State/Province
Western CAPE
ZIP/Postal Code
6530
Country
South Africa
Facility Name
Be Part Research Pty (Ltd)
City
Paarl
State/Province
Western CAPE
ZIP/Postal Code
7626
Country
South Africa
Facility Name
Eba Centelles
City
Centelles
State/Province
Barcelona [barcelona]
ZIP/Postal Code
08540
Country
Spain
Facility Name
Hospital Universitari Germans Trias i Pujol
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital Alvaro Cunqueiro
City
Vigo
State/Province
Pontevedra
ZIP/Postal Code
36312
Country
Spain
Facility Name
IMED Valencia
City
Burjassot
State/Province
Valencia
ZIP/Postal Code
46100
Country
Spain
Facility Name
Complexo Hospitalario Universitario da Coruna
City
A Coruna
ZIP/Postal Code
15006
Country
Spain
Facility Name
Complexo Hospitalario Universitario da Coruna
City
A Coruña
ZIP/Postal Code
15006
Country
Spain
Facility Name
Hospital Universitario de la Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Universitario Virgen de Valme
City
Sevilla
ZIP/Postal Code
41014
Country
Spain
Facility Name
Siriraj Hospital, Mahidol University
City
BangkokNoi
State/Province
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Riverside Bangkok Hotel
City
Bangplud
State/Province
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Bangkok Centre Hotel
City
Bangrak
State/Province
Bangkok
ZIP/Postal Code
10500
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
Baiyoke Suite Hotel
City
Ratchathewi
State/Province
Bangkok
ZIP/Postal Code
10400
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
Khon Kaen Univerisity Field Hospital, Student Dormitory 26, Khon Kaen University
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
Facility Name
Srinagarind Hospital
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
Facility Name
Cukurova University Medical Faculty
City
Balcali
State/Province
Adana
ZIP/Postal Code
01330
Country
Turkey
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
Gaziantep Universitesi Tip Fakultesi Sahinbey Uygulama ve Arastirma Hastanesi
City
Gaziantep
ZIP/Postal Code
27310
Country
Turkey
Facility Name
Istanbul University Istanbul Medical Faculty
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey
Facility Name
Istanbul University Cerrahpasa-Cerrahpasa Medical Faculty
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Facility Name
Medipol Mega University Hospital
City
Istanbul
ZIP/Postal Code
34214
Country
Turkey
Facility Name
Acibadem University Atakent Hospital
City
Istanbul
ZIP/Postal Code
34303
Country
Turkey
Facility Name
Basaksehir Cam ve Sakura Sehir Hastanesi
City
Istanbul
ZIP/Postal Code
34480
Country
Turkey
Facility Name
Izmir Suat Seren Chest Disease and Surgery Training and Research Hospital
City
Izmir
ZIP/Postal Code
35110
Country
Turkey
Facility Name
Kocaeli University Medical Faculty
City
Kocaeli
ZIP/Postal Code
41380
Country
Turkey
Facility Name
Mersin University Medical Faculty
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
Regional Communal Nonprofit Institution "Chernivtsi Regional Clinical Hospital"
City
Chernivtsi
ZIP/Postal Code
58001
Country
Ukraine
Facility Name
Communal non-commercial Enterprise "City Clinical Hospital №3" of Chernivtsi City Council
City
Chernivtsi
ZIP/Postal Code
58002
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
Municipal Non-profit Enterprise "Ivano-Frankivsk Regional Phthisiopulmonology Center of
City
Ivano-Frankivsk
ZIP/Postal Code
76018
Country
Ukraine
Facility Name
Communal nonprofit enterprise "Central City Clinical Hospital of Ivano-Frankivsk City Council"
City
Ivano-Frankivsk
ZIP/Postal Code
76025
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 "Oleksandrivska Kyiv City Clinical Hospital" Of Executive Body Of
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 "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 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
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=C4671002
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

Evaluation of Protease Inhibition for COVID-19 in Standard-Risk Patients (EPIC-SR).

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