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

NCT ID: NCT05011513

Last Updated: 2023-08-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 1440 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-25
• Study Completion Date: 2022-07-25

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.

Conditions

COVID-19

Study Design

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

Study Groups

PF-07321332/ritonavir

Orally administered PF-07321332+ritonavir

Group Type: EXPERIMENTAL

PF-07321332

Intervention Type: DRUG

PF-07321332 (tablet)

Ritonavir

Intervention Type: DRUG

Ritonavir (capsule)

Placebo

Orally administered Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo (tablet)

Placebo

Intervention Type: DRUG

Placebo (capsule)

Interventions

PF-07321332

PF-07321332 (tablet)

Intervention Type: DRUG

Ritonavir

Ritonavir (capsule)

Intervention Type: DRUG

Placebo

Placebo (tablet)

Intervention Type: DRUG

Placebo

Placebo (capsule)

Intervention Type: DRUG

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

• 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

Mesa, Arizona, United States

Matrix Mobile Health Clinic #49, #35, and #62

Scottsdale, Arizona, United States

The Institute for Liver Health dba Arizona Clinical Trials

Tucson, Arizona, United States

Hope Clinical Research

Canoga Park, California, United States

Lightship

El Segundo, California, United States

Ascada Research

Fullerton, California, United States

Atella Clinical Research LLC.

La Palma, California, United States

Ark Clinical Research

Long Beach, California, United States

South Bay Clinical Research Institute

Redondo Beach, California, United States

Benchmark Research

Sacramento, California, United States

Optimus Medical Group

San Francisco, California, United States

Hope Clinical Research (COVID Satellite Site)

West Hills, California, United States

Future Innovative Treatments, LLC

Colorado Springs, Colorado, 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

Omega Research Orlando, LLC

DeBary, 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

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

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 d/b/a 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, LLC

Orlando, Florida, United States

CDC Research Institute

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

Clinical Site Partners, Inc. dba CSP Orlando

Winter Park, Florida, United States

Accellacare

Ames, Iowa, United States

McFarland Clinic, PC

Ames, Iowa, United States

New Orleans Sinus Center (COVID-19 Testing)

Marrero, Louisiana, United States

Tandem Clinical Research GI, LLC

Marrero, Louisiana, United States

Southern Clinical Research Associates, LLC

Metairie, Louisiana, United States

Mercury Street Medical Group, PLLC

Butte, Montana, United States

Excel Clinical research

Las Vegas, Nevada, United States

AXCES Research Group

Santa Fe, New Mexico, United States

NYC Health + Hospitals / Harlem

New York, New York, United States

Monroe Biomedical Research

Monroe, North Carolina, United States

Accellacare

Wilmington, North Carolina, United States

Innovo Research: Wilmington Health

Wilmington, North Carolina, United States

Avera McKennan Hospital & University Health Center

Sioux Falls, South Dakota, United States

Avera Research Institute

Sioux Falls, South Dakota, United States

PharmaTex Research, LLC

Amarillo, Texas, United States

ARC Clinical Research at William Cannon

Austin, Texas, United States

St Hope Foundation

Bellaire, Texas, United States

Conroe Willis Medical Research

Conroe, Texas, United States

South Texas Clinical Research

Corpus Christi, Texas, United States

SignatureCare Emergency Center

Houston, Texas, United States

Trio Clinical Trials, LLC

Houston, Texas, United States

Next Level Urgent Care

Houston, Texas, United States

LinQ Research, LLC

Pearland, Texas, United States

Epic Medical Research

Red Oak, Texas, United States

Endeavor Clinical Trials, LLC

San Antonio, Texas, United States

BFHC Research

San Antonio, Texas, United States

Tranquility Research

Webster, Texas, United States

TMPG Clinical Research

Newport News, Virginia, United States

TPMG Clinical Research

Newport News, Virginia, 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

Hospital de Clinicas Presidente Nicolas Avellaneda

San Miguel de Tucumán, Tucumán Province, Argentina

Clinica Mayo Urgencias Medicas Cruz Blanca SRL

San Miguel de Tucumán, Tucumán Province, Argentina

Hospital Privado Centro Médico de Córdoba

Córdoba, , Argentina

Chronos Pesquisa Clinica

Brasília, Federal District, Brazil

Hospital Agamenon Magalhaes

Recife, Pernambuco, Brazil

IBPClin - Instituto Brasil de Pesquisa Clínica

Rio de Janeiro, Rio de Janeiro, Brazil

Instituto Nacional de Infectologia Evandro Chagas - INI/FIOCRUZ

Rio de Janeiro, Rio de Janeiro, Brazil

Centro de Estudos e Pesquisas em Moléstias Infecciosas

Natal, Rio Grande do Norte, Brazil

Hospital De Clinicas De Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

CECOR - Centro Oncológico de Roraima

Boa Vista, Roraima/rr, Brazil

Hospital Dia do Pulmao

Blumenau, Santa Catarina, Brazil

Hospital e Maternidade Celso Pierro - PUC Campinas / Sociedade Campineira de Educação e Instruçã

Campinas, São Paulo, Brazil

CECIP JAÚ - Centro de Estudos Clínicos do Interior Paulista - LTDA

Jaú, São Paulo, Brazil

CEMEC - Centro Multidisciplinar de Estudos Clínicos

São Bernardo do Campo, São Paulo, Brazil

Hospital Alemão Oswaldo Cruz

São Paulo, São Paulo, Brazil

Unidade Referenciada Oswaldo Cruz Vergueiro

São Paulo, São Paulo, Brazil

Clinica de Alergia Martti Antila

Sorocaba, São Paulo, Brazil

Instituto de Infectologia Emilio Ribas

São Paulo, , Brazil

Individual Practice for Primary Medical Care - IPPMC - Dr. P. Panayotov EOOD

Burgas, , Bulgaria

"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

Multiprofile Hospital for Active Treatment Sveti Ivan Rilski - Razgrad AD

Razgrad, , Bulgaria

"Specialized Hospital for Active Treatment of Pneumo-Physiatric Diseases Dr. Dimitar Gramatikov -

Rousse, , Bulgaria

Multiprofile Hospital for Active Treatment - Samokov EOOD

Samokov, , Bulgaria

Medical Center-1-Sevlievo EOOD

Sevlievo, , 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

MHAT "St. Sofia" EOOD

Sofia, , Bulgaria

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

Stara Zagora, , Bulgaria

Multiprofile Hospital for Active Treatment Targovishte AD

Targovishte, , Bulgaria

Outpatient Clinic for Primary Outpatient Medical Care "Puls" - Dr. Mladen Buchvarov EOOD

Tsarevo, , 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

Fundacion Centro de Investigacion Clinica CIC

Medellín, Antioquia, Colombia

Centro de Investigacion en Reumatologia y Especialidades Medicas S.A.S, CIREEM S.A.S

Bogota, Cundinamarca, Colombia

Fundacion Cardiomet Cequin

Armenia, Quindío Department, Colombia

Zdraví-Fit, s.r.o.

Protivín, , Czechia

Nemocnice Slany

Slaný, , Czechia

Trial Pharma Kft.

Békéscsaba, , Hungary

Semmelweis University Varosmajori Sziv Es Ergyogyaszati Klinika

Budapest, , Hungary

Varosmajori Sziv- es Ergyogyaszati Klinika

Budapest, , Hungary

Debreceni Egyetem Klinikai Kozpont Infektologiai Klinika

Debrecen, , Hungary

Agria-Study Kft.

Eger, , Hungary

Trial Pharma Kft.

Gyula, , Hungary

Medifarma-98 Kft.

Nyíregyháza, , Hungary

International University of Health and Welfare Narita Hospital

Narita, Chiba, Japan

Rakuwakai Otowa Hospital

Kyoto, Kyoto, Japan

Tokyo Shinagawa Hospital

Shinagawa-ku, Tokyo, Japan

Sekino Hospital

Toshimaku, Tokyo, Japan

Kyushu Medical Center

Fukuoka, , Japan

Hospital Raja Perempuan Zainab II

Kota Bharu, Kelantan, Malaysia

Hospital Taiping

Taiping, Perak, Malaysia

Hospital Miri

Miri, Sarawak, Malaysia

Klinik Kesihatan Kuang

Rawang, Selangor, Malaysia

Clinical Research Institute S.C.

Saltillo, Coahuila, Mexico

Asociación Mexicana para la Investigación Clínica A.C.

Pachuca, Hidalgo, Mexico

JM Research SC

Cuernavaca, Morelos, Mexico

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

Monterrey, Nuevo León, Mexico

Eukarya Pharmasite S.C.

Monterrey, Nuevo León, Mexico

Oaxaca Site Management Organization

Oaxaca City, Oaxaca, Mexico

EME RED Hospitalaria

Mérida, Yucatán, Mexico

Kohler & Milstein Research S.A. De C.V.

Mérida, Yucatán, Mexico

Instituto de Investigaciones Clínicas para la Salud

Durango, , Mexico

FAICIC Clinical Research

Veracruz, , Mexico

Sociedad de Metabolismo y Corazon S.C.

Veracruz, , Mexico

KLIMED Marek Klimkiewicz

Bialystok, , Poland

Tomasz Blicharski Lubelskie Centrum Diagnostyczne

Świdnik, , Poland

WIP Warsaw IBD Point Profesor Kierkus

Warsaw, , Poland

Centrum Badań Klinicznych Piotr Napora Lekarze Spółka Partnerska

Wroclaw, , Poland

Clinical Research Management Group Inc

Ponce, , Puerto Rico

Advance Medical Research Center

San Juan, , Puerto Rico

Delta Health Care srl

Bucharest, , Romania

HODOSI - MED, s.r.o.

Moldava nad Bodvou, , Slovakia

MUDr. Viliam Cibik, PhD., s.r.o.

Pruské, , Slovakia

Plucna ambulancia Hrebenar, s.r.o.

Spišská Nová Ves, , Slovakia

ALERGIA s.r.o.

Topoľčany, , Slovakia

Global Clinical Trials

Port Elizabeth, Eastern Cape, South Africa

Worthwhile Clinical Trials

Benoni, Gauteng, South Africa

Reimed Vosloorus

Boksburg, Gauteng, South Africa

Lenasia Clinical Trial Centre

Johannesburg, Gauteng, South Africa

Botho Ke Bontle Health Services

Pretoria, Gauteng, South Africa

Clinical Trial Systems (Pty) Ltd

Pretoria, Gauteng, South Africa

Sandton Medical Clinic

Sandton, Gauteng, South Africa

FCRN Clinical Trial Centre

Vereeniging, 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

TASK Eden

George, Western Cape, South Africa

Be Part Research Pty (Ltd)

Paarl, Western Cape, South Africa

Chonnam National University Bitgoeul Hospital

Gwangju, , South Korea

Boramae Medical Center

Seoul, , South Korea

SMG-SNU Boramae Medical Center

Seoul, , South Korea

Eba Centelles

Centelles, Barcelona [barcelona], Spain

Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, Spain

Hospital Alvaro Cunqueiro

Vigo, Pontevedra, Spain

IMED Valencia

Burjassot, Valencia, Spain

Complexo Hospitalario Universitario da Coruna

A Coruña, , Spain

Hospital Universitario de la Paz

Madrid, , Spain

Hospital Universitario Virgen de Valme

Seville, , Spain

Bangkok Centre Hotel

Bang Rak, Bangkok, Thailand

Siriraj Hospital, Mahidol University

BangkokNoi, Bangkok, Thailand

Riverside Bangkok Hotel

Bangplud, Bangkok, Thailand

Thai Red Cross Emerging Infectious Diseases (EDI) Clinic

Pathumwan,, Bangkok, Thailand

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

Pathumwan, Bangkok, Thailand

Baiyoke Suite Hotel

Ratchathewi, Bangkok, Thailand

Department of Internal Medicine, Faculty of Medicine, Prince of Songkla University,

Hat Yai, Changwat Songkhla, Thailand

Khon Kaen Univerisity Field Hospital, Student Dormitory 26, Khon Kaen University

Khon Kaen, , Thailand

Srinagarind Hospital

Khon Kaen, , Thailand

Cukurova University Medical Faculty

Balcali, Adana, Turkey (Türkiye)

Ankara University Medical Faculty, Ibni-Sina Hospital

Ankara, , Turkey (Türkiye)

Hacettepe University Medical Faculty Hospital

Ankara, , Turkey (Türkiye)

Akdeniz Universitesi Hastanesi

Antalya, , Turkey (Türkiye)

Gaziantep Universitesi Tip Fakultesi Sahinbey Uygulama ve Arastirma Hastanesi

Gaziantep, , Turkey (Türkiye)

Istanbul University Istanbul Medical Faculty

Istanbul, , Turkey (Türkiye)

Istanbul University Cerrahpasa-Cerrahpasa Medical Faculty

Istanbul, , Turkey (Türkiye)

Medipol Mega University Hospital

Istanbul, , Turkey (Türkiye)

Acibadem University Atakent Hospital

Istanbul, , Turkey (Türkiye)

Basaksehir Cam ve Sakura Sehir Hastanesi

Istanbul, , Turkey (Türkiye)

Izmir Suat Seren Chest Disease and Surgery Training and Research Hospital

Izmir, , Turkey (Türkiye)

Kocaeli University Medical Faculty

Kocaeli, , Turkey (Türkiye)

Mersin University Medical Faculty

Mersin, , Turkey (Türkiye)

Sakarya University Training and Research Hospital

Sakarya, , 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 Clinical Hospital №3" of Chernivtsi City Council

Chernivtsi, , Ukraine

Municipal Nonprofit Enterprise "Ivano-Frankivsk Regional Clinical Infectious Diseases Hospital of

Ivano-Frankivsk, , Ukraine

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

Ivano-Frankivsk, , Ukraine

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

Ivano-Frankivsk, , Ukraine

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

Kharkiv, , Ukraine

Municipal Non-profit Enterprise "Oleksandrivska Kyiv City Clinical Hospital" Of Executive Body Of

Kyiv, , Ukraine

Municipal non-commercial enterprise "Kyiv City Clinical Hospital #1" Of Executive Body Of the Kyiv

Kyiv, , Ukraine

Kyiv Railway Clinical Hospital No.2 of Branch "Health Center of the Public Joint Stock Company

Kyiv, , 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 Enterprise "Poltava Regional Clinical Infectious Diseases Hospital" of Poltava Regional

Poltava, , Ukraine

Municipal Non-commercial Enterprise "Vinnytsia City Clinical Hospital №1"

Vinnytsia, , Ukraine

Communal Enterprise "Hospital #1" of Zhytomyr City Council

Zhytomyr, , Ukraine

Countries

United States; Argentina; Brazil; Bulgaria; Colombia; Czechia; Hungary; Japan; Malaysia; Mexico; Poland; Puerto Rico; Romania; Slovakia; South Africa; South Korea; Spain; Thailand; Turkey (Türkiye); Ukraine

References

Brown TM, Kanu C, Harrington M. Assessing participants' experiences with the COVID-19 symptom diary in a clinical trial. J Patient Rep Outcomes. 2025 Aug 11;9(1):99. doi: 10.1186/s41687-025-00901-5.

Reference Type: DERIVED

PMID: 40788441 (View on PubMed)

Baniecki ML, Guan S, Rai DK, Yang Q, Lee JT, Hao L, Weinstein E, Hyde C, Cardin RD, Soares H, Hammond J. Integrated virologic analysis of resistance to nirmatrelvir/ritonavir in individuals across four phase 2/3 clinical studies for the treatment of COVID-19. EBioMedicine. 2025 Aug;118:105819. doi: 10.1016/j.ebiom.2025.105819. Epub 2025 Jun 30.

Reference Type: DERIVED

PMID: 40592258 (View on PubMed)

Hammond J, Fountaine RJ, Yunis C, Fleishaker D, Almas M, Bao W, Wisemandle W, Baniecki ML, Hendrick VM, Kalfov V, Simon-Campos JA, Pypstra R, Rusnak JM. Nirmatrelvir for Vaccinated or Unvaccinated Adult Outpatients with Covid-19. N Engl J Med. 2024 Apr 4;390(13):1186-1195. doi: 10.1056/NEJMoa2309003.

Reference Type: DERIVED

PMID: 38598573 (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=C4671002

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

Other Identifiers

2021-002857-28

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

EPIC-SR

Identifier Type: OTHER

Identifier Source: secondary_id

C4671002

Identifier Type: -

Identifier Source: org_study_id