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

NCT ID: NCT05047601

Last Updated: 2023-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 2954 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-09
• Study Completion Date: 2022-04-12

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

Conditions

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

PF-07321332/ritonavir (5 days)

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

Group Type: EXPERIMENTAL

PF-07321332

Intervention Type: DRUG

PF-07321332

Placebo for PF-07321332

Intervention Type: DRUG

Placebo

Placebo for Ritonavir

Intervention Type: DRUG

Placebo

Ritonavir

Intervention Type: DRUG

Ritonavir

PF-07321332/ritonavir (10-Day)

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

Group Type: EXPERIMENTAL

PF-07321332

Intervention Type: DRUG

PF-07321332

Ritonavir

Intervention Type: DRUG

Ritonavir

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo for PF-07321332

Intervention Type: DRUG

Placebo

Placebo for Ritonavir

Intervention Type: DRUG

Placebo

Interventions

PF-07321332

PF-07321332

Intervention Type: DRUG

Placebo for PF-07321332

Placebo

Intervention Type: DRUG

Placebo for Ritonavir

Placebo

Intervention Type: DRUG

Ritonavir

Ritonavir

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Cahaba Research Inc

Pelham, Alabama, United States

The Institute for Liver Health dba Arizona Clinical Trials

Tucson, Arizona, United States

Ascada Health PC

Fullerton, California, United States

Optimus Medical Group

San Francisco, California, United States

Synergy Healthcare

Bradenton, Florida, United States

MOORE Clinical Research, Inc.

Brandon, Florida, United States

TrueBlue Clinical Research

Brandon, Florida, United States

Herco Medical and Research Center Inc

Coral Gables, Florida, United States

Advance Clinical Research Group

Cutler Bay, Florida, United States

Beautiful Minds Clinical Research Center

Cutler Bay, Florida, United States

Qway Research

Hialeah, Florida, United States

Eastern Research Inc

Hialeah, Florida, United States

Inpatient Research Clinic

Hialeah, Florida, United States

Doral Medical Research,LLC

Hialeah, Florida, United States

Unlimited Medical Research Group, LLC

Hialeah Gardens, Florida, United States

ASCLEPES Research Centers

Lutz, Florida, United States

Angels Clinical Research Institute

Miami, Florida, United States

LCC Medical Research Institute, LLC

Miami, Florida, United States

Premium Medical Research Corp

Miami, Florida, United States

Global Health Clinical Trials Corp

Miami, Florida, United States

South Florida Research Center, Inc.

Miami, Florida, United States

University of Miami Health System

Miami, Florida, United States

I.V.A.M. Clinical & Investigational Center, LLC

Miami, Florida, United States

Medical Research of Westchester Inc

Miami, Florida, United States

C'A Research

Miami, Florida, United States

ProLive Medical Research, Corp.

Miami, Florida, United States

Entrust Clinical Research

Miami, Florida, United States

Reed Medical Research

Miami, Florida, United States

Kendall South Medical Center, Inc.

Miami, Florida, United States

Clinical Site Partners, Inc dba CSP Miami

Miami, Florida, United States

Coral Research Clinic Corp

Miami, Florida, United States

Pro-Care Research Center, Corp.

Miami Gardens, Florida, United States

Savin Medical Group, LLC

Miami Lakes, Florida, United States

Omega Research Orlando

Orlando, Florida, United States

NAPA Research LLC

Pompano Beach, Florida, United States

CDC Research Institute, LLC

Port Saint Lucie, Florida, United States

USPA Advance Concept Medical Research Group LLC

South Miami, Florida, United States

ASCLEPES Research Centers

Spring Hill, Florida, United States

GCP, Global Clinical Professionals

St. Petersburg, Florida, United States

Sunrise Research Institute

Sunrise, Florida, United States

Santos Research Center, CORP

Tampa, Florida, United States

Research by Design, LLC

Chicago, Illinois, United States

Accellacare

Ames, Iowa, United States

McFarland Clinic, PC

Ames, Iowa, United States

Southern Clinical Research Associates. LLC

Metairie, Louisiana, United States

Meridian Clinical Research, LLC

Grand Island, Nebraska, United States

Quality Clinical Research Inc

Omaha, Nebraska, United States

Quality Clinical Research

Omaha, Nebraska, United States

Walmart

Las Vegas, Nevada, United States

Excel Clinical research

Las Vegas, Nevada, United States

Walgreens

Las Vegas, Nevada, United States

NYC Health + Hospitals / Harlem

New York, New York, United States

Monroe Biomedical Research

Monroe, North Carolina, United States

Innovo Research: Wilmington Health

Wilmington, North Carolina, United States

PharmaTex Research, LLC

Amarillo, Texas, United States

Conroe Willis Medical Research

Conroe, Texas, United States

South Texas Clinical Research

Corpus Christi, Texas, United States

SingnatureCare Emergency Center

Houston, Texas, United States

Trio Clinical Trials, LLC

Houston, Texas, United States

C & R Research Services USA

Houston, Texas, United States

SMS Clinical Research, LLC

Mesquite, Texas, United States

Epic Medical Research

Red Oak, Texas, United States

Sun Research Institute

San Antonio, Texas, United States

Tranquility Research

Webster, Texas, United States

Instituto de Investigaciones Clinicas Zarate

Zárate, Buenos Aires, Argentina

Instituto Médico de la Fundación Estudios Clínicos (Fundación Estudios Clínicos)

Rosario, Santa Fe Province, Argentina

Pesquisare Saude S/S Ltda

Santo André, São Paulo, Brazil

Conjunto Hospitalar do Mandaqui

São Paulo, , Brazil

"Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases-Haskovo" Ltd

Haskovo, , Bulgaria

MHAT "Sv.Ivan. Rilski'' Kozloduy EOOD

Kozloduy, , Bulgaria

Diagnostic-Consultative Center I Lom EOOD

Lom, , Bulgaria

Multiprofile Hospital for Active Treatment- Sveti Nikolay Chudotvoretz EOOD

Lom, , Bulgaria

Medical centre Leo Clinic EOOD

Lovech, , Bulgaria

MHAT Heart and Brain EAD

Pleven, , Bulgaria

DCC Sveti Georgi EOOD

Plovdiv, , Bulgaria

MHAT "St. Panteleimon "- Plovdiv

Plovdiv, , Bulgaria

UMHAT Medica Ruse OOD

Rousse, , Bulgaria

Multiprofile Hospital for Active Treatment - Samokov EOOD

Samokov, , Bulgaria

Multiprofile hospital for active treatment - Sliven to Military Medical Academy

Sliven, , Bulgaria

Diagnostic-Consultative Center XXII- Sofia ЕООD

Sofia, , Bulgaria

UMHATEM N. I. Pirogov EAD

Sofia, , Bulgaria

Specialized hospital for active treatment in pulmonology and phthisiology "Stara Zagora" EOOD

Stara Zagora, , Bulgaria

Medical center Leo Clinic EOOD

Varna, , Bulgaria

MOBAL "D-r Stefan Cherkezov" AD

Veliko Tarnovo, , Bulgaria

Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases Vratsa EOOD

Vratsa, , Bulgaria

Clinica de la Costa LTDA.

Barranquilla, Atlántico, Colombia

Caimed S.A.S.

Yopal, Casanare Department, Colombia

Cireem Sas

Bogota, Cundinamarca, Colombia

Doktor Brno s.r.o.

Brno, , Czechia

Zdraví-Fit, s.r.o.

Protivín, , Czechia

Nemocnice Slany

Slaný, , Czechia

Medifarma-98 Kft.

Nyíregyháza, , Hungary

International University of Health and Welfare Narita Hospital

Narita, Chiba, Japan

Rakuwakai Otowa Hospital

Kyoto, Kyoto, Japan

Rinku General Medical Center

Izumisano, Osaka, Japan

Denenchofu Family Clinic

Ōta-ku, Tokyo, Japan

Sekino Hospital

Toshimaku, Tokyo, Japan

Hospital Miri

Miri, Sarawak, Malaysia

Clinical Research Institute Saltillo S.A. de C.V.

Saltillo, Coahuila, Mexico

InfectoLab Consultorios de Especialidad en Infectologia

Tijuana, Estado de Baja California, Mexico

Instituto Jalisciense de Metabolismo, S.C.

Guadalajara, Jalisco, Mexico

Christus- Latam Hub Center of Excellence and Innovation Center S.C.

Monterrey, Nuevo León, Mexico

Eukarya Pharmasite S.C.

Monterrey, Nuevo León, Mexico

EME RED Hospitalaria

Mérida, Yucatán, Mexico

Instituto de Investigaciones Clinicas para la Salud A.C.

Durango, , Mexico

FAICIC Clinical Research

Veracruz, , Mexico

Sociedad de Metabolismo y Corazon S.C.

Veracruz, , Mexico

Centrum Badań Klinicznych Piotr Napora Lekarze Spółka Partnerska

Wroclaw, , Poland

Kirovsk Interdistrict Hospital

Kirovsk, Leningradskaya Oblast', Russia

LLC Trekhgorka Medicine

Odintsovo, Moscow Oblast, Russia

Clinica UZI 4D

Pyatigorsk, Stavropol Kray, Russia

Barnaul City Hospital Number 5

Barnaul, , Russia

Korolev Medicine

Korolyov, , Russia

KDC "Evromedservis", OJSC

Moscow, , Russia

City Polyclinic #44

Saint Petersburg, , Russia

City Polyclinic No. 109

Saint Petersburg, , Russia

LLC Strategic Medical Systems

Saint Petersburg, , Russia

City Out-patient clinic #112

Saint Petersburg, , Russia

"Research Center Eco-safety" LLC

Saint Petersburg, , Russia

LLC Kurator

Saint Petersburg, , Russia

Saint-Petersburg State Budgetary Healthcare Institution "City Pokrovskaya hospital"

Saint Petersburg, , Russia

City Out-patient clinic #4

Saint Petersburg, , Russia

Smolensk State Medical University

Smolensk, , Russia

LLC Family clinic

Yekaterinburg, , Russia

MERC Welkom

Welkom, Free State, South Africa

Worthwhile Clinical Trials

Benoni, Gauteng, South Africa

LCS Clinical Research

Johannesburg, Gauteng, South Africa

Peermed CTC (Pty) Ltd T/A MERC Kempton

Kempton Park, Gauteng, South Africa

Global Clinical Trials

Pretoria, Gauteng, South Africa

Botho Ke Bontle Health Services

Pretoria, Gauteng, South Africa

About Allergy (PTY) Ltd

Pretoria, Gauteng, South Africa

Into Research

Pretoria, Gauteng, South Africa

Clinical Trial Systems (Pty) Ltd

Pretoria, Gauteng, South Africa

Sandton Medical Clinic

Sandton, Gauteng, South Africa

Synapta Clinical Research Center

Durban, KwaZulu-Natal, South Africa

Dr PJ Sebastian Clinical Research Centre

Durban, KwaZulu-Natal, South Africa

Ahmed Al-Kadi Private Hospital

Mayville, Durban, KwaZulu-Natal, South Africa

Limpopo Clinical Research Initiative

Thabazimbi, Limpopo, South Africa

NHC Thohoyandou CRS

Thohoyandou, Limpopo, South Africa

MERC Middelburg

Middelburg, Mpumalanga, South Africa

Madibeng Centre for Research

Brits, North West, South Africa

FCRN Clinical Trial Centre

Vereeniging, , South Africa

Complexo Hospitalario Universitario da Coruna

A Coruña, , Spain

The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT),

Pathumwan, Bangkok, Thailand

Faculty of Medicine - Khon Kaen University

Muang, Changwat Khon Kaen, Thailand

King Chulalongkorn Memorial Hospital

Bangkok, , Thailand

Faculty of Tropical Medicine, Mahidol University

Bangkok, , Thailand

Tropical Medicine Hospital

Bangkok, , Thailand

Ankara University Medical Faculty, Ibni-Sina Hospital

Ankara, , Turkey (Türkiye)

Istanbul University Istanbul Medical Faculty

Fatih / Istanbul, , Turkey (Türkiye)

Gaziantep Universitesi Tip Fakultesi Sahinbey Uygulama ve Arastirma Hastanesi

Gaziantep, , Turkey (Türkiye)

Acibadem University Atakent Hospital

Istanbul, , Turkey (Türkiye)

Izmir Suat Seren Chest Disease and Surgery Training and Research Hospital

Izmir, , Turkey (Türkiye)

Mersin University Medical Faculty

Mersin, , Turkey (Türkiye)

Karadeniz Teknik Universitesi Farabi Hastanesi

Trabzon, , Turkey (Türkiye)

Regional Communal Nonprofit Institution "Chernivtsi Regional Clinical Hospital"

Chernivtsi, , Ukraine

Communal non-commercial Enterprise "City Central Clinical Hospital" of Chernivtsi City Council

Chernivtsi, , Ukraine

Communal non-profit enterprise "City Clinical Hospital #16" of Dnipro City Council

Dnipro, , Ukraine

Communal nonprofit enterprise "Central City Clinical Hospital of Ivano-Frankivsk City Council"

Ivano-Frankivsk, , Ukraine

Municipal Non-profit Enterprise "Ivano-Frankivsk Regional Phthisiopulmonology Center of

Ivano-Frankivsk, , Ukraine

Municipal Nonprofit Enterprise "City Student Hospital" of Kharkiv City Council

Kharkiv, , Ukraine

Municipal Nonprofit Enterprise of Kharkiv Regional Council "Regional Clinical Infectious Diseases

Kharkiv, , Ukraine

Municipal Nonprofit Enterprise "City Clinic Hospital # 13" of Kharkiv City Council

Kharkiv, , Ukraine

Polyclinic of Center for Medical Services and Rehabilitation of State Joint-Stock Holding Company

Kyiv, , Ukraine

Municipal Nonprofit Enterprise "Lviv City Clinic Hospital #4"

Lviv, , Ukraine

Municipal NonProfit Enterprise of the Lviv Regional Council Lviv Regional Information and Analytical

Lviv, , Ukraine

Municipal Nonprofit Enterprise "Lviv City Clinic Hospital #4"

Lviv, , Ukraine

Municipal Enterprise "Poltava Regional Clinical Infectious Diseases Hospital" of Poltava Regional

Poltava, , Ukraine

Municipal Enterprise "Volyn Regional Clinical Hospital" of Volyn Regional Council

Tarasove Village, , Ukraine

Communal Enterprise "Hospital #1" of Zhytomyr City Council

Zhytomyr, , Ukraine

Countries

United States; Argentina; Brazil; Bulgaria; Colombia; Czechia; Hungary; Japan; Malaysia; Mexico; Poland; Russia; South Africa; Spain; Thailand; Turkey (Türkiye); Ukraine

References

Hammond J, Yunis C, Fountaine RJ, Luscan G, Burr AM, Zhang W, Wisemandle W, Soares H, Baniecki ML, Hendrick VM, Kalfov V, Pypstra R, Rusnak JM. Oral Nirmatrelvir-Ritonavir as Postexposure Prophylaxis for Covid-19. N Engl J Med. 2024 Jul 18;391(3):224-234. doi: 10.1056/NEJMoa2309002.

Reference Type: DERIVED

PMID: 39018532 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://pmiform.com/clinical-trial-info-request?StudyID=C4671006

To obtain contact information for a study center near you, click here.

Other Identifiers

2021-002894-24

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

EPIC-PEP

Identifier Type: OTHER

Identifier Source: secondary_id

C4671006

Identifier Type: -

Identifier Source: org_study_id