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A Study of a Potential Oral Treatment to Prevent COVID-19 in Adults Who Are Exposed to Household Member(s) With a Confirmed Symptomatic COVID-19 Infection

Primary Purpose

COVID-19

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

About this trial

This is an interventional prevention 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:

  • Participants who have a negative screening SARS-CoV-2 rapid antigen test result and who are asymptomatic household contacts with exposure within 96 hours to an individual who is symptomatic and recently tested positive for SARS CoV-2.
  • Fertile participants must agree to use a highly effective method of contraception

Exclusion Criteria:

  • History of SARS-CoV-2 infection in the past 6 months
  • Experiencing measured fever (documented temperature >38˚C or 100.4˚F) or other signs or symptoms consistent with COVID-19
  • Known medical history of active liver disease
  • Chronic Kidney Disease or have known moderate to severe renal impairment.
  • Known Human Immunodeficiency Virus (HIV) infection with viral load > 400 copies/ml within the last 6 months or taking prohibited medications for HIV treatment
  • Suspected or confirmed concurrent active systemic infection
  • Active cancer requiring treatment with prohibited medication.
  • 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 approved, authorized, or investigational anti-SARS-CoV-2 mAb, convalescent plasma, other drugs for treatment of COVID-19, or other anti-SARS-CoV-2 biologic products within 6 months of screening
  • Has received any SARS-CoV-2 vaccine within 6 months prior to screening or is expected to receive a SARS-CoV-2 vaccine or other approved, authorized, or investigational postexposure prophylaxis treatments through Day 38.
  • Participating in another interventional clinical study with an investigational compound or device, including those for COVID-19
  • Known or prior participation in this trial or another trial involving PF-07321332.
  • Females who are pregnant or breastfeeding.

Sites / Locations

  • Cahaba Research Inc
  • The Institute for Liver Health dba Arizona Clinical Trials
  • Ascada Health PC
  • Optimus Medical Group
  • Synergy Healthcare
  • MOORE Clinical Research, Inc.
  • TrueBlue Clinical Research
  • 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
  • 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.
  • University of Miami Health System
  • I.V.A.M. Clinical & Investigational Center, LLC
  • Medical Research of Westchester Inc
  • C'A Research
  • ProLive Medical Research, Corp.
  • Entrust Clinical Research
  • Reed Medical Research
  • Kendall South Medical Center, Inc.
  • Clinical Site Partners, Inc dba CSP Miami
  • Coral Research Clinic Corp
  • Omega Research Orlando
  • NAPA Research LLC
  • CDC Research Institute, LLC
  • GCP, Global Clinical Professionals
  • USPA Advance Concept Medical Research Group LLC
  • ASCLEPES Research Centers
  • Sunrise Research Institute
  • Santos Research Center, CORP
  • Research by Design, LLC
  • Accellacare
  • McFarland Clinic, PC
  • Southern Clinical Research Associates. LLC
  • Meridian Clinical Research, LLC
  • Quality Clinical Research Inc
  • Quality Clinical Research
  • Walmart
  • Excel Clinical research
  • Walgreens
  • NYC Health + Hospitals / Harlem
  • Monroe Biomedical Research
  • Innovo Research: Wilmington Health
  • PharmaTex Research, LLC
  • Conroe Willis Medical Research
  • South Texas Clinical Research
  • SingnatureCare Emergency Center
  • Trio Clinical Trials, LLC
  • C & R Research Services USA
  • SMS Clinical Research, LLC
  • Epic Medical Research
  • Sun Research Institute
  • Tranquility Research
  • Instituto de Investigaciones Clinicas Zarate
  • Instituto Médico de la Fundación Estudios Clínicos (Fundación Estudios Clínicos)
  • Pesquisare Saude S/S Ltda
  • Conjunto Hospitalar do Mandaqui
  • "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
  • UMHAT Medica Ruse OOD
  • Multiprofile Hospital for Active Treatment - Samokov EOOD
  • Multiprofile hospital for active treatment - Sliven to Military Medical Academy
  • Diagnostic-Consultative Center XXII- Sofia ЕООD
  • UMHATEM N. I. Pirogov EAD
  • Specialized hospital for active treatment in pulmonology and phthisiology "Stara Zagora" EOOD
  • Medical center Leo Clinic EOOD
  • MOBAL "D-r Stefan Cherkezov" AD
  • Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases Vratsa EOOD
  • Clinica de la Costa LTDA.
  • Caimed S.A.S.
  • Cireem Sas
  • Doktor Brno s.r.o.
  • Zdraví-Fit, s.r.o.
  • Nemocnice Slany
  • Medifarma-98 Kft.
  • International University of Health and Welfare Narita Hospital
  • Rakuwakai Otowa Hospital
  • Rinku General Medical Center
  • Denenchofu Family Clinic
  • Sekino Hospital
  • Hospital Miri
  • InfectoLab Consultorios de Especialidad en Infectologia
  • Clinical Research Institute Saltillo S.A. de C.V.
  • Instituto Jalisciense de Metabolismo, S.C.
  • Eukarya Pharmasite S.C.
  • Christus- Latam Hub Center of Excellence and Innovation Center S.C.
  • EME RED Hospitalaria
  • Instituto de Investigaciones Clinicas para la Salud A.C.
  • FAICIC Clinical Research
  • Sociedad de Metabolismo y Corazon S.C.
  • Centrum Badań Klinicznych Piotr Napora Lekarze Spółka Partnerska
  • Kirovsk Interdistrict Hospital
  • LLC Trekhgorka Medicine
  • Clinica UZI 4D
  • Barnaul City Hospital Number 5
  • Korolev Medicine
  • KDC "Evromedservis", OJSC
  • City Polyclinic #44
  • LLC Strategic Medical Systems
  • City Polyclinic No. 109
  • City Out-patient clinic #112
  • "Research Center Eco-safety" LLC
  • LLC Kurator
  • Saint-Petersburg State Budgetary Healthcare Institution "City Pokrovskaya hospital"
  • City Out-patient clinic #4
  • Smolensk State Medical University
  • LLC Family clinic
  • MERC Welkom
  • Worthwhile Clinical Trials
  • LCS Clinical Research
  • Peermed CTC (Pty) Ltd T/A MERC Kempton
  • Global Clinical Trials
  • Botho Ke Bontle Health Services
  • About Allergy (PTY) Ltd
  • Into Research
  • Clinical Trial Systems (Pty) Ltd
  • Sandton Medical Clinic
  • Dr PJ Sebastian Clinical Research Centre
  • Synapta Clinical Research Center
  • Ahmed Al-Kadi Private Hospital
  • Limpopo Clinical Research Initiative
  • NHC Thohoyandou CRS
  • MERC Middelburg
  • Madibeng Centre for Research
  • FCRN Clinical Trial Centre
  • Complexo Hospitalario Universitario da Coruna
  • The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT),
  • Faculty of Medicine - Khon Kaen University
  • King Chulalongkorn Memorial Hospital
  • Faculty of Tropical Medicine, Mahidol University
  • Tropical Medicine Hospital
  • Ankara University Medical Faculty, Ibni-Sina Hospital
  • Istanbul University Istanbul Medical Faculty
  • Gaziantep Universitesi Tip Fakultesi Sahinbey Uygulama ve Arastirma Hastanesi
  • Acibadem University Atakent Hospital
  • Izmir Suat Seren Chest Disease and Surgery Training and Research Hospital
  • Mersin University Medical Faculty
  • Karadeniz Teknik Universitesi Farabi Hastanesi
  • Regional Communal Nonprofit Institution "Chernivtsi Regional Clinical Hospital"
  • Communal non-commercial Enterprise "City Central Clinical Hospital" of Chernivtsi City Council
  • Communal non-profit enterprise "City Clinical Hospital #16" of Dnipro City Council
  • Communal nonprofit enterprise "Central City Clinical Hospital of Ivano-Frankivsk City Council"
  • Municipal Non-profit Enterprise "Ivano-Frankivsk Regional Phthisiopulmonology Center of
  • Municipal Nonprofit Enterprise "City Student Hospital" of Kharkiv City Council
  • Municipal Nonprofit Enterprise of Kharkiv Regional Council "Regional Clinical Infectious Diseases
  • Municipal Nonprofit Enterprise "City Clinic Hospital # 13" of Kharkiv City Council
  • Polyclinic of Center for Medical Services and Rehabilitation of State Joint-Stock Holding Company
  • Municipal Nonprofit Enterprise "Lviv City Clinic Hospital #4"
  • Municipal NonProfit Enterprise of the Lviv Regional Council Lviv Regional Information and Analytical
  • 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
  • Communal Enterprise "Hospital #1" of Zhytomyr City Council

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

PF-07321332/ritonavir (5 days)

PF-07321332/ritonavir (10-Day)

Placebo

Arm Description

Participants will receive PF-07321332/ritonavir every 12 hours from Day 1 through Day 5 followed by Placebo every 12 hours from Day 6 through Day 10

Participants will receive PF-07321332/ritonavir every 12 hours from Day 1 through Day 10.

Participants will receive placebo every 12 hours from Day 1 through Day 10.

Outcomes

Primary Outcome Measures

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

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 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 Who Developed Symptomatic RT-PCR or RAT Confirmed SARS-CoV-2 Infection Through Day 14: Among Participants With Negative RT-PCR at Baseline With Increased Risk of Severe COVID-19 Illness
Percentage of participants who had a symptomatic RT-PCR or RAT confirmed SARS-Cov-2 infection were reported in this outcome measure. The risk factors associated with severe covid-19 illness included age greater than or equal to 60 years, body mass index greater than 25, social history of smoking and presence of comorbidities. Index case was defined as participants with symptomatic COVID-19.
Percentage of Participants With COVID-19 Related Hospitalization or Death From Any Cause Through Day 28: Among Participants With Negative RT-PCR at Baseline With Increased Risk of Severe COVID-19 Illness
The risk factors associated with severe covid-19 illness included age greater than or equal to 60 years, body mass index greater than 25, social history of smoking and presence of comorbidities.
Percentage of Participants With Asymptomatic RT-PCR or RAT Confirmed SARS-CoV-2 Infection Through Day 14: Among Participants With Negative RT-PCR at Baseline
Percentage of participants who had asymptomatic RT-PCR or RAT confirmed SARS-CoV-2 infection through day 14 among participants with negative RT-PCR at baseline were reported in this outcome measure. Index case was defined as participants with symptomatic COVID-19.
Time to RT-PCR or RAT Confirmed SARS-CoV-2 Infection Through Day 14: Among Participants With Negative RT-PCR at Baseline
Number of days between first dose and confirmation of the SARS-CoV-2 infection by RT-PCR or RAT was reported in this outcome measure.
Percentage of Participants With Symptomatic RT-PCR or RAT Confirmed SARS-CoV-2 Infection Through Day 14: Among Participants With Positive RT-PCR at Baseline
Percentage of participants with a positive RT-PCR result at baseline who had a symptomatic SARS-CoV-2 infection confirmed by RAT or RT-PCR through Day 14 were reported in this outcome measure. Index case was defined as participants with symptomatic COVID-19.
Percentage of Participants With Symptomatic RT-PCR or RAT Confirmed SARS-CoV-2 Infection Through Day 14: Among Participants With Negative, Positive or Missing RT-PCR at Baseline
Percentage of participants with a negative, positive, or missing RT-PCR result at baseline, who had a symptomatic SARS-CoV-2 infection confirmed by RAT or RT-PCR through Day 14 were reported in this outcome measure. Index case was defined as participants with symptomatic COVID-19.
Percentage of Participants With no, Mild, Moderate, or Severe Signs and Symptoms Attributed to COVID-19 Through Day 28: Among Participants With Negative RT-PCR at Baseline
Participants were categorized according to severity of signs and symptoms as no, mild, moderate, severe in this outcome measure. The 12 signs and symptoms included stuffy or runny nose, sore throat, shortness of breath or difficulty breathing, cough, low energy or tiredness, muscle or body aches, headache, chills or shivering, feeling hot or feverish, nausea, vomiting, diarrhea. Participants recorded their daily severity rating of their symptoms over the past 24 hours based on a 4-point scale in which 0 was reported if no symptoms were present; 1 if mild; 2 if moderate; and 3 if severe.
Number of Days of Symptomatic RT-PCR or RAT Confirmed SARS-CoV- 2 Infection Through Day 28: Among Participants With Negative RT-PCR at Baseline
This outcome measure has been reported in terms of number of participants according to days of symptomatic SARS-CoV-2 infection through Day 28.
Plasma Concentration Versus Time Summary of Nirmatrelvir (PF-07321332)
Percentage of Participants With Death Event Through Day 38: Among Participants With Negative RT-PCR at Baseline
Percentage of participants with death (all-cause) event were reported in this outcome measure.
Viral Load in Nasal Samples Over Time: Among Participants With Negative RT-PCR at Baseline
Nasal samples were collected to estimate the viral load in terms of logarithm to base 10 (log10) copies per milliliter in participants with negative RT-PCR at baseline and were reported in this outcome measure.
Viral Load in Nasal Samples Over Time: Among Participants With Positive RT-PCR at Baseline
Nasal samples were collected to estimate the viral load in terms of logarithm to base 10 (log10) copies per milliliter in participants with positive RT-PCR at baseline and were reported in this outcome measure.
Number of Days of Hospitalization and Intensive Care Unit (ICU) Stay: Among Participants With Negative RT-PCR at Baseline
This outcome measure has been presented in terms of participants according to number of days of hospitalization and in ICU as 0 days and more than or equal to 1 day.
Number of COVID-19 Related Medical Visits Through Day 28: Among Participants With Negative RT-PCR at Baseline
In this outcome measure number of COVID-19 related medical visits per day were reported. Number of medical visits per day = number of medical visits/number of days follow up through day 28 visit or the last collection date on or before day 28, if day 28 visit was missing.

Full Information

First Posted
September 1, 2021
Last Updated
April 11, 2023
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT05047601
Brief Title
A Study of a Potential Oral Treatment to Prevent COVID-19 in Adults Who Are Exposed to Household Member(s) With a Confirmed Symptomatic COVID-19 Infection
Official Title
A PHASE 2/3, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO CONTROLLED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF 2 REGIMENS OF ORALLY ADMINISTERED PF 07321332/RITONAVIR IN PREVENTING SYMPTOMATIC SARS-COV-2 INFECTION IN ADULT HOUSEHOLD CONTACTS OF AN INDIVIDUAL WITH SYMPTOMATIC COVID-19
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
September 9, 2021 (Actual)
Primary Completion Date
April 12, 2022 (Actual)
Study Completion Date
April 12, 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 clinical trial is to learn whether the study medicine prevent symptoms of COVID-19 in adults who have been exposed to household member(s) with a confirmed symptomatic COVID-19 infection. All participants in the study will receive treatment for COVID-19 as needed, based on their regular doctor's recommendation. Two-thirds of participants will also receive two study medicines (PF-07321332 and ritonavir) by mouth twice a day for either five or ten days. We will compare the experiences of people receiving the study medicines to those of the people who do not. This will help us determine if the study medicines are safe and effective

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
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Eligible participants who are asymptomatic household contacts of an individual with symptomatic COVID-19 will be randomized (1:1:1) to receive orally every 12 hours: PF-07321332/ritonavir for 5 days followed by placebo for 5 days or PF-07321332/ritonavir for 10 days or Placebo for 10 days
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double Blind Double Dummy
Allocation
Randomized
Enrollment
2954 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PF-07321332/ritonavir (5 days)
Arm Type
Experimental
Arm Description
Participants will receive PF-07321332/ritonavir every 12 hours from Day 1 through Day 5 followed by Placebo every 12 hours from Day 6 through Day 10
Arm Title
PF-07321332/ritonavir (10-Day)
Arm Type
Experimental
Arm Description
Participants will receive PF-07321332/ritonavir every 12 hours from Day 1 through Day 10.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo every 12 hours from Day 1 through Day 10.
Intervention Type
Drug
Intervention Name(s)
PF-07321332
Intervention Description
PF-07321332
Intervention Type
Drug
Intervention Name(s)
Placebo for PF-07321332
Intervention Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Placebo for Ritonavir
Intervention Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Ritonavir
Intervention Description
Ritonavir
Primary Outcome Measure Information:
Title
Percentage of Participants Who Developed Symptomatic RT-PCR or RAT Confirmed SARS-CoV-2 Infection Through Day 14: Among Participants With Negative RT-PCR at Baseline
Description
Percentage of participants who developed symptomatic Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) or Rapid Antigen Test (RAT) confirmed SARS-Cov-2 infection were reported in this outcome measure. Index case was defined as participants with symptomatic COVID-19.
Time Frame
From Day 1 to Day 14
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 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 end of safety follow-up (Day 38)
Title
Percentage of Participants Who Developed Symptomatic RT-PCR or RAT Confirmed SARS-CoV-2 Infection Through Day 14: Among Participants With Negative RT-PCR at Baseline With Increased Risk of Severe COVID-19 Illness
Description
Percentage of participants who had a symptomatic RT-PCR or RAT confirmed SARS-Cov-2 infection were reported in this outcome measure. The risk factors associated with severe covid-19 illness included age greater than or equal to 60 years, body mass index greater than 25, social history of smoking and presence of comorbidities. Index case was defined as participants with symptomatic COVID-19.
Time Frame
From Day 1 to Day 14
Title
Percentage of Participants With COVID-19 Related Hospitalization or Death From Any Cause Through Day 28: Among Participants With Negative RT-PCR at Baseline With Increased Risk of Severe COVID-19 Illness
Description
The risk factors associated with severe covid-19 illness included age greater than or equal to 60 years, body mass index greater than 25, social history of smoking and presence of comorbidities.
Time Frame
From Day 1 to Day 28
Title
Percentage of Participants With Asymptomatic RT-PCR or RAT Confirmed SARS-CoV-2 Infection Through Day 14: Among Participants With Negative RT-PCR at Baseline
Description
Percentage of participants who had asymptomatic RT-PCR or RAT confirmed SARS-CoV-2 infection through day 14 among participants with negative RT-PCR at baseline were reported in this outcome measure. Index case was defined as participants with symptomatic COVID-19.
Time Frame
From Day 1 to Day 14
Title
Time to RT-PCR or RAT Confirmed SARS-CoV-2 Infection Through Day 14: Among Participants With Negative RT-PCR at Baseline
Description
Number of days between first dose and confirmation of the SARS-CoV-2 infection by RT-PCR or RAT was reported in this outcome measure.
Time Frame
From Day 1 to Day 14
Title
Percentage of Participants With Symptomatic RT-PCR or RAT Confirmed SARS-CoV-2 Infection Through Day 14: Among Participants With Positive RT-PCR at Baseline
Description
Percentage of participants with a positive RT-PCR result at baseline who had a symptomatic SARS-CoV-2 infection confirmed by RAT or RT-PCR through Day 14 were reported in this outcome measure. Index case was defined as participants with symptomatic COVID-19.
Time Frame
From Day 1 to Day 14
Title
Percentage of Participants With Symptomatic RT-PCR or RAT Confirmed SARS-CoV-2 Infection Through Day 14: Among Participants With Negative, Positive or Missing RT-PCR at Baseline
Description
Percentage of participants with a negative, positive, or missing RT-PCR result at baseline, who had a symptomatic SARS-CoV-2 infection confirmed by RAT or RT-PCR through Day 14 were reported in this outcome measure. Index case was defined as participants with symptomatic COVID-19.
Time Frame
From Day 1 to Day 14
Title
Percentage of Participants With no, Mild, Moderate, or Severe Signs and Symptoms Attributed to COVID-19 Through Day 28: Among Participants With Negative RT-PCR at Baseline
Description
Participants were categorized according to severity of signs and symptoms as no, mild, moderate, severe in this outcome measure. The 12 signs and symptoms included stuffy or runny nose, sore throat, shortness of breath or difficulty breathing, cough, low energy or tiredness, muscle or body aches, headache, chills or shivering, feeling hot or feverish, nausea, vomiting, diarrhea. Participants recorded their daily severity rating of their symptoms over the past 24 hours based on a 4-point scale in which 0 was reported if no symptoms were present; 1 if mild; 2 if moderate; and 3 if severe.
Time Frame
From Day 1 to Day 28
Title
Number of Days of Symptomatic RT-PCR or RAT Confirmed SARS-CoV- 2 Infection Through Day 28: Among Participants With Negative RT-PCR at Baseline
Description
This outcome measure has been reported in terms of number of participants according to days of symptomatic SARS-CoV-2 infection through Day 28.
Time Frame
From Day 1 to Day 28
Title
Plasma Concentration Versus Time Summary of Nirmatrelvir (PF-07321332)
Time Frame
Day 1: 1 hour post dose; Day 5: 2 hours pre-dose
Title
Percentage of Participants With Death Event Through Day 38: Among Participants With Negative RT-PCR at Baseline
Description
Percentage of participants with death (all-cause) event were reported in this outcome measure.
Time Frame
From Day 1 to Day 38
Title
Viral Load in Nasal Samples Over Time: Among Participants With Negative RT-PCR at Baseline
Description
Nasal samples were collected to estimate the viral load in terms of logarithm to base 10 (log10) copies per milliliter in participants with negative RT-PCR at baseline and were reported in this outcome measure.
Time Frame
From Day 1 to Day 14
Title
Viral Load in Nasal Samples Over Time: Among Participants With Positive RT-PCR at Baseline
Description
Nasal samples were collected to estimate the viral load in terms of logarithm to base 10 (log10) copies per milliliter in participants with positive RT-PCR at baseline and were reported in this outcome measure.
Time Frame
From Day 1 to Day 14
Title
Number of Days of Hospitalization and Intensive Care Unit (ICU) Stay: Among Participants With Negative RT-PCR at Baseline
Description
This outcome measure has been presented in terms of participants according to number of days of hospitalization and in ICU as 0 days and more than or equal to 1 day.
Time Frame
From Day 1 to Day 28
Title
Number of COVID-19 Related Medical Visits Through Day 28: Among Participants With Negative RT-PCR at Baseline
Description
In this outcome measure number of COVID-19 related medical visits per day were reported. Number of medical visits per day = number of medical visits/number of days follow up through day 28 visit or the last collection date on or before day 28, if day 28 visit was missing.
Time Frame
From Day 1 to Day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants who have a negative screening SARS-CoV-2 rapid antigen test result and who are asymptomatic household contacts with exposure within 96 hours to an individual who is symptomatic and recently tested positive for SARS CoV-2. Fertile participants must agree to use a highly effective method of contraception Exclusion Criteria: History of SARS-CoV-2 infection in the past 6 months Experiencing measured fever (documented temperature >38˚C or 100.4˚F) or other signs or symptoms consistent with COVID-19 Known medical history of active liver disease Chronic Kidney Disease or have known moderate to severe renal impairment. Known Human Immunodeficiency Virus (HIV) infection with viral load > 400 copies/ml within the last 6 months or taking prohibited medications for HIV treatment Suspected or confirmed concurrent active systemic infection Active cancer requiring treatment with prohibited medication. 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 approved, authorized, or investigational anti-SARS-CoV-2 mAb, convalescent plasma, other drugs for treatment of COVID-19, or other anti-SARS-CoV-2 biologic products within 6 months of screening Has received any SARS-CoV-2 vaccine within 6 months prior to screening or is expected to receive a SARS-CoV-2 vaccine or other approved, authorized, or investigational postexposure prophylaxis treatments through Day 38. Participating in another interventional clinical study with an investigational compound or device, including those for COVID-19 Known or prior participation in this trial or another trial involving PF-07321332. 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
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Ascada Health PC
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Optimus Medical Group
City
San Francisco
State/Province
California
ZIP/Postal Code
94102
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
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
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
University of Miami Health System
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
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
Medical Research of Westchester Inc
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
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 dba 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
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, LLC
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
Research by Design, LLC
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60643
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
Southern Clinical Research Associates. LLC
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70001
Country
United States
Facility Name
Meridian Clinical Research, LLC
City
Grand Island
State/Province
Nebraska
ZIP/Postal Code
68803
Country
United States
Facility Name
Quality Clinical Research Inc
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68112
Country
United States
Facility Name
Quality Clinical Research
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Walmart
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89108
Country
United States
Facility Name
Excel Clinical research
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
Walgreens
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89121
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
Innovo Research: Wilmington Health
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
PharmaTex Research, LLC
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79109
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
SingnatureCare 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
SMS Clinical Research, LLC
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75149
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
Tranquility Research
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
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
Pesquisare Saude S/S Ltda
City
Santo André
State/Province
SP
ZIP/Postal Code
09080-110
Country
Brazil
Facility Name
Conjunto Hospitalar do Mandaqui
City
São Paulo
ZIP/Postal Code
02401-400
Country
Brazil
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
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
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
Specialized hospital for active treatment in pulmonology and phthisiology "Stara Zagora" EOOD
City
Stara Zagora
ZIP/Postal Code
6000
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
Clinica de la Costa LTDA.
City
Barranquilla
State/Province
Atlantico
ZIP/Postal Code
080020
Country
Colombia
Facility Name
Caimed S.A.S.
City
Yopal
State/Province
Casanare
ZIP/Postal Code
850001
Country
Colombia
Facility Name
Cireem Sas
City
Bogota
State/Province
Cundinamarca
ZIP/Postal Code
110221
Country
Colombia
Facility Name
Doktor Brno s.r.o.
City
Brno
ZIP/Postal Code
602 00
Country
Czechia
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
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
Rinku General Medical Center
City
Izumisano
State/Province
Osaka
ZIP/Postal Code
598-8577
Country
Japan
Facility Name
Denenchofu Family Clinic
City
Ota
State/Province
Tokyo
ZIP/Postal Code
145-0071
Country
Japan
Facility Name
Sekino Hospital
City
Toshimaku
State/Province
Tokyo
ZIP/Postal Code
171-0014
Country
Japan
Facility Name
Hospital Miri
City
Miri
State/Province
Sarawak
ZIP/Postal Code
98000
Country
Malaysia
Facility Name
InfectoLab Consultorios de Especialidad en Infectologia
City
Tijuana
State/Province
BAJA California
ZIP/Postal Code
22010
Country
Mexico
Facility Name
Clinical Research Institute Saltillo S.A. de C.V.
City
Saltillo
State/Province
Coahuila
ZIP/Postal Code
25020
Country
Mexico
Facility Name
Instituto Jalisciense de Metabolismo, S.C.
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44670
Country
Mexico
Facility Name
Eukarya Pharmasite S.C.
City
Monterrey
State/Province
Nuevo LEON
ZIP/Postal Code
64718
Country
Mexico
Facility Name
Christus- Latam Hub Center of Excellence and Innovation Center S.C.
City
Monterrey
State/Province
Nuevo LEÓN
ZIP/Postal Code
64060
Country
Mexico
Facility Name
EME RED Hospitalaria
City
Mérida
State/Province
Yucatán
ZIP/Postal Code
97000
Country
Mexico
Facility Name
Instituto de Investigaciones Clinicas para la Salud A.C.
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
Centrum Badań Klinicznych Piotr Napora Lekarze Spółka Partnerska
City
Wroclaw
ZIP/Postal Code
51-162
Country
Poland
Facility Name
Kirovsk Interdistrict Hospital
City
Kirovsk
State/Province
Leningrad Region
ZIP/Postal Code
187342
Country
Russian Federation
Facility Name
LLC Trekhgorka Medicine
City
Odintsovo
State/Province
Moscow Region
ZIP/Postal Code
143005
Country
Russian Federation
Facility Name
Clinica UZI 4D
City
Pyatigorsk
State/Province
Stavropol Region
ZIP/Postal Code
357502
Country
Russian Federation
Facility Name
Barnaul City Hospital Number 5
City
Barnaul
ZIP/Postal Code
656045
Country
Russian Federation
Facility Name
Korolev Medicine
City
Korolev
ZIP/Postal Code
141070
Country
Russian Federation
Facility Name
KDC "Evromedservis", OJSC
City
Moscow
ZIP/Postal Code
115419
Country
Russian Federation
Facility Name
City Polyclinic #44
City
Saint Petersburg
ZIP/Postal Code
192071
Country
Russian Federation
Facility Name
LLC Strategic Medical Systems
City
Saint Petersburg
ZIP/Postal Code
194291
Country
Russian Federation
Facility Name
City Polyclinic No. 109
City
Saint-Petersburg
ZIP/Postal Code
192298
Country
Russian Federation
Facility Name
City Out-patient clinic #112
City
Saint-Petersburg
ZIP/Postal Code
195427
Country
Russian Federation
Facility Name
"Research Center Eco-safety" LLC
City
Saint-Petersburg
ZIP/Postal Code
196143
Country
Russian Federation
Facility Name
LLC Kurator
City
Saint-Petersburg
ZIP/Postal Code
196240
Country
Russian Federation
Facility Name
Saint-Petersburg State Budgetary Healthcare Institution "City Pokrovskaya hospital"
City
Saint-Petersburg
ZIP/Postal Code
199106
Country
Russian Federation
Facility Name
City Out-patient clinic #4
City
Saint-Petersburg
ZIP/Postal Code
199406
Country
Russian Federation
Facility Name
Smolensk State Medical University
City
Smolensk
ZIP/Postal Code
214019
Country
Russian Federation
Facility Name
LLC Family clinic
City
Yekaterinburg
ZIP/Postal Code
620109
Country
Russian Federation
Facility Name
MERC Welkom
City
Welkom
State/Province
FREE State
ZIP/Postal Code
9460
Country
South Africa
Facility Name
Worthwhile Clinical Trials
City
Benoni
State/Province
Gauteng
ZIP/Postal Code
1500
Country
South Africa
Facility Name
LCS Clinical Research
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
1868
Country
South Africa
Facility Name
Peermed CTC (Pty) Ltd T/A MERC Kempton
City
Kempton Park
State/Province
Gauteng
ZIP/Postal Code
1619
Country
South Africa
Facility Name
Global Clinical Trials
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0001
Country
South Africa
Facility Name
Botho Ke Bontle Health Services
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0122
Country
South Africa
Facility Name
About Allergy (PTY) Ltd
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0181
Country
South Africa
Facility Name
Into Research
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0181
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
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
Limpopo Clinical Research Initiative
City
Thabazimbi
State/Province
Limpopo
ZIP/Postal Code
0380
Country
South Africa
Facility Name
NHC Thohoyandou CRS
City
Thohoyandou
State/Province
Limpopo
ZIP/Postal Code
0950
Country
South Africa
Facility Name
MERC Middelburg
City
Middelburg
State/Province
Mpumalanga
ZIP/Postal Code
1055
Country
South Africa
Facility Name
Madibeng Centre for Research
City
Brits
State/Province
North WEST
ZIP/Postal Code
0250
Country
South Africa
Facility Name
FCRN Clinical Trial Centre
City
Vereeniging
ZIP/Postal Code
1935
Country
South Africa
Facility Name
Complexo Hospitalario Universitario da Coruna
City
A Coruña
ZIP/Postal Code
15006
Country
Spain
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
King Chulalongkorn Memorial Hospital
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Facility Name
Faculty of Tropical Medicine, Mahidol University
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Tropical Medicine Hospital
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Ankara University Medical Faculty, Ibni-Sina Hospital
City
Ankara
ZIP/Postal Code
06230
Country
Turkey
Facility Name
Istanbul University Istanbul Medical Faculty
City
Fatih / Istanbul
ZIP/Postal Code
34093
Country
Turkey
Facility Name
Gaziantep Universitesi Tip Fakultesi Sahinbey Uygulama ve Arastirma Hastanesi
City
Gaziantep
ZIP/Postal Code
27310
Country
Turkey
Facility Name
Acibadem University Atakent Hospital
City
Istanbul
ZIP/Postal Code
34303
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
Mersin University Medical Faculty
City
Mersin
ZIP/Postal Code
33110
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 Central Clinical Hospital" of Chernivtsi City Council
City
Chernivtsi
ZIP/Postal Code
58002
Country
Ukraine
Facility Name
Communal non-profit enterprise "City Clinical Hospital #16" of Dnipro City Council
City
Dnipro
ZIP/Postal Code
49069
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 Non-profit Enterprise "Ivano-Frankivsk Regional Phthisiopulmonology Center of
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 Nonprofit Enterprise "City Clinic Hospital # 13" of Kharkiv City Council
City
Kharkiv
ZIP/Postal Code
61124
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
79005
Country
Ukraine
Facility Name
Municipal NonProfit Enterprise of the Lviv Regional Council Lviv Regional Information and Analytical
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
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=C4671006
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

A Study of a Potential Oral Treatment to Prevent COVID-19 in Adults Who Are Exposed to Household Member(s) With a Confirmed Symptomatic COVID-19 Infection

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