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

NCT04960202 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: C46710052021-002895-38EPIC-HR
• Study Type: interventional
• Target: 2,091
• Locations: 20 countries
• Sites: 201

Brief Summary

The purpose of this study is to determine whether PF-07321332/ritonavir is safe and effective for the treatment of adults who are ill with COVID-19 and do not need to be in the hospital, but are at an increased risk of developing severe illness. Throughout the study period, provision will be made to allow study visits to be conducted at a participant's home or another non-clinic location if available. The total study duration is up to 24 weeks.

Conditions

COVID-19

Keywords

severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)

Outcome Measures

Primary Outcomes (1)

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

  Percentage of participants with COVID-19 related hospitalization or death from any cause during the first 28 days of the study was estimated using the Kaplan-Meier (KM) method. Using KM method, survival probability for each time interval was calculated as the number of participants surviving divided by the number of participants at risk. Participants who had the event, dropped out, or moved out were not counted as "at risk" i.e., participants who were lost were considered "censored" and were not counted in the denominator.

  From Day 1 to Day 28

Secondary Outcomes (37)

• Number of Participants With Treatment Emergent Adverse Events (TEAEs)

  From start of study intervention (Day 1) up to end of safety follow-up (Day 34)

• Number of Participants With AEs Leading to Discontinuation and Serious Adverse Events (SAEs)

  From start of study intervention (Day 1) up to end of safety follow-up (Day 34)

• Percentage of Participants With Covid-19 Related Hospitalization or Death From Any Cause Through Day 28- Modified Intent-To-Treat 1 (mITT1) Population

  From Day 1 to Day 28

• Time to Sustained Alleviation of All Targeted COVID-19 Signs and Symptoms Through Day 28- mITT Population

  From Day 1 (baseline) to Day 28

• Time to Sustained Alleviation of All Targeted COVID-19 Signs and Symptoms Through Day 28- mITT1 Population

  From Day 1 (baseline) to Day 28

Study Arms (2)

PF-07321332/ritonavir

EXPERIMENTAL

Orally administered PF-07321332+ritonavir

Drug: PF-07321332; Drug: Ritonavir

Placebo

PLACEBO COMPARATOR

Orally administered placebo

Drug: Placebo

Interventions

PF-07321332 DRUG

PF-07321332 (tablet)

PF-07321332/ritonavir

Ritonavir DRUG

Ritonavir (capsule)

PF-07321332/ritonavir

Placebo DRUG

Placebo (tablet or capsule)

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed SARS-CoV-2 infection within 5 days prior to randomization
• Initial onset of COVID-19 signs/symptoms within 5 days prior to the day of randomization and at least 1 of the specified COVID-19 signs/symptoms present on the day of randomization
• Fertile participants must agree to use a highly effective method of contraception
• Has at least 1 characteristic or underlying medical condition associated with an increased risk of developing severe illness from COVID-19

You may not qualify if:

• History of or need for hospitalization for the medical treatment of COVID-19
• Prior to current disease episode, any confirmed SARS-CoV-2 infection
• Known medical history of active liver disease
• Receiving dialysis or have known moderate to severe renal impairment
• Known human immunodeficiency virus (HIV) infection with a viral load greater than 400 copies/mL or taking prohibited medications for HIV treatment
• Suspected or confirmed concurrent active systemic infection other than COVID-19
• History of hypersensitivity or other contraindication to any of the components of the study intervention
• Current or expected use of any medications or substances that are highly dependent on CYP3A4 for clearance or are strong inducers of CYP3A4
• Has received or is expected to receive convalescent COVID-19 plasma
• Has received or is expected to receive any dose of a SARS-CoV-2 vaccine before the Day 34 visit
• Participating in another interventional clinical study with an investigational compound or device, including those for COVID-19 through the long-term follow-up visit
• Known prior participation in this trial or other trial involving PF-07321332
• Oxygen saturation of \<92% on room air, or on their standard home oxygen supplementation for those who regularly receive chronic supplementary oxygen for an underlying lung condition
• Females who are pregnant or breastfeeding

Sponsors & Collaborators

• Pfizer: lead

Study Sites (201)

Cahaba Research Inc

Pelham, Alabama, 35124, United States

Location

The Institute for Liver Health dba Arizona Clinical Trials

Mesa, Arizona, 85210, United States

Location

The Institute for Liver Health dba Arizona Clinical Trials

Tucson, Arizona, 85712, United States

Location

Hope Clinical Research

Canoga Park, California, 91303, United States

Location

Ascada Research

Fullerton, California, 92835, United States

Location

Atella Clinical Research LLC.

La Palma, California, 90623, United States

Location

Ark Clinical Research

Long Beach, California, 90806, United States

Location

American Institute of Research

Los Angeles, California, 90017, United States

Location

South Bay Clinical Research Institute

Redondo Beach, California, 90277, United States

Location

Hope Clinical Research (COVID Satellite Site)

West Hills, California, 91304, United States

Location

Future Innovative Treatments, LLC

Colorado Springs, Colorado, 80907, United States

Location

Xera Med Research

Boca Raton, Florida, 33487, United States

Location

MOORE Clinical Research, Inc.

Brandon, Florida, 33511, United States

Location

Innovative Research of West Florida, Inc.

Clearwater, Florida, 33756, United States

Location

Herco Medical and Research Center Inc

Coral Gables, Florida, 33134, United States

Location

Advance Clinical Research Group

Cutler Bay, Florida, 33157, United States

Location

Beautiful Minds Clinical Research Center

Cutler Bay, Florida, 33157, United States

Location

Qway Research

Hialeah, Florida, 33010, United States

Location

Eastern Research Inc

Hialeah, Florida, 33013, United States

Location

Inpatient Research Clinic

Hialeah, Florida, 33013, United States

Location

Doral Medical Research LLC.

Hialeah, Florida, 33016, United States

Location

Doral Medical Research,LLC

Hialeah, Florida, 33016, United States

Location

Unlimited Medical Research Group, LLC

Hialeah Gardens, Florida, 33018, United States

Location

Advanced Pulmonary Research Institute

Loxahatchee Groves, Florida, 33470, United States

Location

Angels Clinical Research Institute

Miami, Florida, 33122, United States

Location

LCC Medical Research Institute, LLC

Miami, Florida, 33126, United States

Location

Premium Medical Research Corp

Miami, Florida, 33126, United States

Location

Global Health Clinical Trials Corp

Miami, Florida, 33135, United States

Location

South Florida Research Center, Inc.

Miami, Florida, 33135, United States

Location

Suncoast Research Group, LLC

Miami, Florida, 33135, United States

Location

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

Miami, Florida, 33144, United States

Location

C'A Research

Miami, Florida, 33174, United States

Location

ProLive Medical Research, Corp.

Miami, Florida, 33175, United States

Location

Entrust Clinical Research

Miami, Florida, 33176, United States

Location

Reed Medical Research

Miami, Florida, 33176, United States

Location

Kendall South Medical Center

Miami, Florida, 33185, United States

Location

Clinical Site Partners, Inc d/b/a CSP Miami

Miami, Florida, 33186, United States

Location

Coral Research Clinic Corp

Miami, Florida, 33186, United States

Location

Savin Medical Group, LLC

Miami Lakes, Florida, 33014, United States

Location

Omega Research Orlando, LLC

Orlando, Florida, 32808, United States

Location

NAPA Research LLC

Pompano Beach, Florida, 33064, United States

Location

CDC Research Institute

Port Saint Lucie, Florida, 34952, United States

Location

USPA Advance Concept Medical Research Group LLC

South Miami, Florida, 33143, United States

Location

GCP, Global Clinical Professionals

St. Petersburg, Florida, 33705, United States

Location

Sunrise Research Institute

Sunrise, Florida, 33325, United States

Location

Santos Research Center, CORP

Tampa, Florida, 33615, United States

Location

Clinical Site Partners, Inc. dba CSP Orlando

Winter Park, Florida, 32789, United States

Location

Research by Design, LLC

Chicago, Illinois, 60643, United States

Location

New Orleans Sinus Center (COVID-19 Testing)

Marrero, Louisiana, 70072, United States

Location

Tandem Clinical Research GI, LLC

Marrero, Louisiana, 70072, United States

Location

Mercury Street Medical Group, PLLC

Butte, Montana, 59701, United States

Location

Excel Clinical research

Las Vegas, Nevada, 89109, United States

Location

Meridian Clinical Research, LLC

Endwell, New York, 13760, United States

Location

Monroe Biomedical Research

Monroe, North Carolina, 28112, United States

Location

Accellacare

Wilmington, North Carolina, 28401, United States

Location

Premier Medical Group

Clarksville, Tennessee, 37040, United States

Location

PharmaTex Research, LLC

Amarillo, Texas, 79109, United States

Location

ARC Clinical Research at William Cannon

Austin, Texas, 78745, United States

Location

St Hope Foundation

Bellaire, Texas, 77401, United States

Location

Conroe Willis Medical Research

Conroe, Texas, 77304, United States

Location

South Texas Clinical Research

Corpus Christi, Texas, 78413, United States

Location

SignatureCare Emergency Center

Houston, Texas, 77008, United States

Location

Trio Clinical Trials, LLC

Houston, Texas, 77008, United States

Location

C & R Research Services USA

Houston, Texas, 77022, United States

Location

Next Level Urgent Care

Houston, Texas, 77057, United States

Location

SMS Clinical Research, LLC

Mesquite, Texas, 75149, United States

Location

SMS Clinical Research

Mesquite, Texas, 75149, United States

Location

LinQ Research, LLC

Pearland, Texas, 77584, United States

Location

Epic Medical Research

Red Oak, Texas, 75154, United States

Location

Sun Research Institute

San Antonio, Texas, 78215, United States

Location

BFHC Research

San Antonio, Texas, 78249, United States

Location

Tranquility Research

Webster, Texas, 77598, United States

Location

TPMG (Tidewater Physicians Multispecialty Group) Clinical Research

Newport News, Virginia, 23606, United States

Location

Instituto de Investigaciones Clinicas Zarate

Zárate, Buenos Aires, B2800DGH, Argentina

Location

Hospital De Clínicas Presidente Dr.Nicolas Avellaneda

San Miguel de Tucumán, Tucumán Province, 4000, Argentina

Location

Chronos Pesquisa Clinica

Brasília, Federal District, 72145-450, Brazil

Location

Hospital Agamenon Magalhaes

Recife, Pernambuco, 52051-380, Brazil

Location

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

Jaú, São Paulo, 17201-130, Brazil

Location

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

Burgas, 8001, Bulgaria

Location

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

Haskovo, 6300, Bulgaria

Location

MHAT "Sv.Ivan. Rilski'' Kozloduy EOOD

Kozloduy, 3320, Bulgaria

Location

Diagnostic-Consultative Center I Lom EOOD

Lom, 3600, Bulgaria

Location

Multiprofile Hospital for Active Treatment- Sveti Nikolay Chudotvoretz EOOD

Lom, 3600, Bulgaria

Location

Medical centre Leo Clinic EOOD

Lovech, 5500, Bulgaria

Location

MHAT Heart and Brain EAD

Pleven, 5800, Bulgaria

Location

DCC Sveti Georgi EOOD

Plovdiv, 4000, Bulgaria

Location

MHAT "St. Panteleimon "- Plovdiv

Plovdiv, 4004, Bulgaria

Location

Multiprofile Hospital for Active Treatment Sveti Ivan Rilski - Razgrad AD

Razgrad, 7200, Bulgaria

Location

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

Rousse, 7002, Bulgaria

Location

UMHAT Medica Ruse OOD

Rousse, 7013, Bulgaria

Location

Multiprofile Hospital for Active Treatment - Samokov EOOD

Samokov, 2000, Bulgaria

Location

Medical Center-1-Sevlievo EOOD

Sevlievo, 5400, Bulgaria

Location

Multiprofile Hospital For Active Treatment Shumen AD

Shumen, 9700, Bulgaria

Location

Multiprofile hospital for active treatment - Sliven to Military Medical Academy

Sliven, 8800, Bulgaria

Location

MHAT "Dr. Ivan Seliminski" AD, Sliven

Sliven, 8801, Bulgaria

Location

Diagnostic-Consultative Center XXII- Sofia ЕООD

Sofia, 1113, Bulgaria

Location

MHAT "St. Sofia" EOOD

Sofia, 1618, Bulgaria

Location

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

Stara Zagora, 6000, Bulgaria

Location

Multiprofile Hospital for Active Treatment Targovishte AD

Targovishte, 7700, Bulgaria

Location

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

Tsarevo, 8260, Bulgaria

Location

Medical center Leo Clinic EOOD

Varna, 9020, Bulgaria

Location

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

Vratsa, 3000, Bulgaria

Location

Fundacion Cardiomet Cequin

Armenia, Quindío Department, 630004, Colombia

Location

Zdraví-Fit, s.r.o.

Protivín, 398 11, Czechia

Location

Nemocnice Slany

Slaný, 274 01, Czechia

Location

Trial Pharma Kft.

Békéscsaba, 5600, Hungary

Location

Debreceni Egyetem Klinikai Kozpont Infektologiai Klinika

Debrecen, 4031, Hungary

Location

Agria-Study Kft.

Eger, 3300, Hungary

Location

Trial Pharma Kft.

Gyula, 5700, Hungary

Location

Medifarma-98 Kft.

Nyíregyháza, 4400, Hungary

Location

AIIMS Raipur

Raipur, Chhattisgarh, 492099, India

Location

Jupiter Hospital

Vadodara, Gujarat, 390012, India

Location

BGS Global Institute of Medical Sciences and Hospital

Bangalore, Karnataka, 560060, India

Location

Lisie Hospital

Kochi, Kerala, 682018, India

Location

Jehangir Clinical Development Centre Pvt. Ltd

Pune, Maharashtra, 411001, India

Location

Lifepoint Research LLP

Pune, Maharashtra, 411057, India

Location

Jawahar Lal Nehru Medical College

Ajmer, Rajasthan, 305001, India

Location

Apex Hospitals Pvt Ltd

Jaipur, Rajasthan, 302017, India

Location

Maharaja Agrasen Superspeciality Hospital

Jaipur, Rajasthan, 302039, India

Location

Nil Ratan Sircar Medical College and Hospital

Kolkata, West Bengal, 700014, India

Location

Aakash Healthcare Private Limited

New Delhi, 110075, India

Location

Sardar Patel Medical College

Pavan PURI Bikaner, Rajasthan, 334003, India

Location

International University of Health and Welfare Narita Hospital

Narita, Chiba, 286-8520, Japan

Location

National Hokkaido Medical Center

Sapporo, Hokkaido, 063-0005, Japan

Location

Rinku General Medical Center

Izumisano, Osaka, 598-8577, Japan

Location

Tokyo Medical University Hachioji Medical Center

Hachiōji, Tokyo, 1930998, Japan

Location

National Center for Global Health and Medicine

Shinjuku, Tokyo, 162-8655, Japan

Location

Hospital Umum Sarawak

Kuching, Sarawak, 93586, Malaysia

Location

Hospital Miri

Miri, Sarawak, 98000, Malaysia

Location

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

Saltillo, Coahuila, 25020, Mexico

Location

Asociacion Mexicana para la Investigacion Clinica A.C. (AMIC)

Pachuca, Hidalgo, 42070, Mexico

Location

Instituto Jalisciense de Metabolismo, S.C.

Guadalajara, Jalisco, 44670, Mexico

Location

JM Research SC

Cuernavaca, Morelos, 62290, Mexico

Location

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

Monterrey, Nuevo León, 64060, Mexico

Location

Eukarya Pharmasite S.C.

Monterrey, Nuevo León, 64718, Mexico

Location

Oaxaca Site Management Organization

Oaxaca City, Oaxaca, 68000, Mexico

Location

InfectoLab Consultorios de Especialidad en Infectologia

Baja California, Tijuana, 22010, Mexico

Location

EME RED Hospitalaria

Mérida, Yucatán, 97000, Mexico

Location

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

Mérida, Yucatán, 97070, Mexico

Location

Centro de Investigacion Clinica Del Pacifico SA de CV

Acapulco, Mexico

Location

Hospital Cardiologica Aguascalientes

Aguascalientes, CP 201230, Mexico

Location

Instituto de Investigaciones Clínicas para la Salud

Durango, 34000, Mexico

Location

FAICIC S. de R.L. de C.V.

Veracruz, 91900, Mexico

Location

Sociedad de Metabolismo y Corazon S.C.

Veracruz, 91900, Mexico

Location

Arké SMO S.A de C.V

Veracruz, 91910, Mexico

Location

KLIMED Marek Klimkiewicz

Bialystok, 15-704, Poland

Location

Centrum Badań Klinicznych Piotr Napora Lekarze Spółka Partnerska

Wroclaw, 51-162, Poland

Location

Clinical Research Management Group Inc

Ponce, 00780, Puerto Rico

Location

Advance Medical Research Center

San Juan, 00926, Puerto Rico

Location

LLC Trekhgorka Medicine

Odintsovo, Moscow Oblast, 143005, Russia

Location

Barnaul City Hospital Number 5

Barnaul, 656045, Russia

Location

KDC "Evromedservis", OJSC

Moscow, 115419, Russia

Location

Smolensk State Medical University

Smolensk, 214019, Russia

Location

MERC Welkom

Welkom, Free State, 9460, South Africa

Location

East Rand Research Centre T/A Worthwhile Clinical Trials

Benoni, Gauteng, 1500, South Africa

Location

Botho Ke Bontle Health Services

Pretoria, Gauteng, 0122, South Africa

Location

Synapta Clinical Research Center

Durban, KwaZulu-Natal, 4001, South Africa

Location

Limpopo Clinical Research Initiative

Thabazimbi, Limpopo, 0380, South Africa

Location

MERC Middelburg

Middelburg, Mpumalanga, 1055, South Africa

Location

Kyungpook National University Chilgok Hospital

Daegu, 41404, South Korea

Location

Incheon Medical Center

Incheon, 22532, South Korea

Location

Chonnam National University Bitgoeul Hospital

Nam-gu, 61748, South Korea

Location

SMG-SNU Boramae Medical Center

Seoul, 07061, South Korea

Location

Eba Centelles

Centelles, Barcelona [barcelona], 08540, Spain

Location

Complexo Hospitalario Universitario da Coruna

A Coruña, 15006, Spain

Location

Bangkok Centre Hotel

Bang Rak, Bangkok, 10500, Thailand

Location

Chula Field Hospital, Chulalongkorn University Sport center (Chantanayingyong Gymnasium)

Pathum Wan District,, Bangkok, 10330, Thailand

Location

Thai Red Cross Emerging Infectious Diseases (EDI) Clinic

Pathumwan,, Bangkok, 10330, Thailand

Location

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

Pathumwan, Bangkok, 10330, Thailand

Location

Faculty of Medicine - Khon Kaen University

Muang, Changwat Khon Kaen, 40002, Thailand

Location

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

Hat Yai, Changwat Songkhla, 90110, Thailand

Location

Ankara University Medical Faculty, Ibni-Sina Hospital

Ankara, 06230, Turkey (Türkiye)

Location

Hacettepe University Medical Faculty Hospital

Ankara, 06230, Turkey (Türkiye)

Location

Akdeniz Universitesi Hastanesi

Antalya, 07059, Turkey (Türkiye)

Location

Istanbul Medipol University Clinical Research Ethics Committee

Beykoz / Istanbul, 34810, Turkey (Türkiye)

Location

Gaziantep University Medical Faculty

Gaziantep, 27300, Turkey (Türkiye)

Location

Istanbul Yedikule Gogus Hastaliklari ve Gogus Cerrahisi Egitim Arastirma Hastanesi

Istanbul, 34020, Turkey (Türkiye)

Location

Istanbul University Cerrahpasa-Cerrahpasa Medical Faculty

Istanbul, 34098, Turkey (Türkiye)

Location

Acibadem Saglik Hizmetleri ve Tic.A.S, Acibadem Atakent Hastanesi

Istanbul, 34303, Turkey (Türkiye)

Location

Istanbul Universitesi Klinik Arastirmalar Mukemmeliyet Uygulama ve Arastirma Merkezi

Istanbul, 34452, Turkey (Türkiye)

Location

Basaksehir Cam ve Sakura Sehir Hastanesi

Istanbul, 34480, Turkey (Türkiye)

Location

Kocaeli University Medical Faculty

Kocaeli, 41380, Turkey (Türkiye)

Location

Sbü Dr. Suat Seren Göğüs Hastaliklari Ve Cerrahisi Eğitim Ve Araştirma Hastanesi

Konak/Izmir, 35170, Turkey (Türkiye)

Location

Mersin University Health Research and Application Hospital

Mersin, 33110, Turkey (Türkiye)

Location

Sakarya University Training and Research Hospital

Sakarya, 54100, Turkey (Türkiye)

Location

Karadeniz Teknik Universitesi Farabi Hastanesi

Trabzon, 61080, Turkey (Türkiye)

Location

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

Dnipro, 49069, Ukraine

Location

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

Ivano-Frankivsk, 76007, Ukraine

Location

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

Ivano-Frankivsk, 76018, Ukraine

Location

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

Kharkiv, 61002, Ukraine

Location

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

Kharkiv, 61096, Ukraine

Location

"Municipal Non-Profit Enterprise "Alexander Clinical Hospital of Kyiv" of the Kyiv City Council

Kyiv, 01601, Ukraine

Location

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

Kyiv, 02091, Ukraine

Location

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

Kyiv, 03049, Ukraine

Location

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

Kyiv, 04050, Ukraine

Location

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

Lviv, 79008, Ukraine

Location

Municipal Nonprofit Enterprise "Lviv City Clinic Hospital #4"

Lviv, 79011, Ukraine

Location

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

Poltava, 36011, Ukraine

Location

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

Tarasove Village, 45625, Ukraine

Location

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

Vinnytsia, 21029, Ukraine

Location

Communal Enterprise "Hospital #1" of Zhytomyr City Council

Zhytomyr, 10002, Ukraine

Location

Related Publications (4)

• Ansari W, Coetzer H, Gebo KA, Ren J, Scott A, Cappelleri JC, Cha-Silva AS, Leister-Tebbe H. Patient-Reported Outcomes of Nirmatrelvir Treatment for High-Risk, Nonhospitalized Adults With Symptomatic COVID-19. Open Forum Infect Dis. 2025 Aug 1;12(8):ofaf449. doi: 10.1093/ofid/ofaf449. eCollection 2025 Aug.

  PMID: 40809391 DERIVED

• 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.

  PMID: 40592258 DERIVED

• Hammond J, Leister-Tebbe H, Gardner A, Abreu P, Bao W, Wisemandle W, Ansari W, Harrington MA, Simon-Campos A, Chew KW, Pypstra R, Rusnak JM. Alleviation of COVID-19 Symptoms and Reduction in Healthcare Utilization Among High-risk Patients Treated With Nirmatrelvir/Ritonavir (NMV/R): A Phase 3 Randomized Trial. Clin Infect Dis. 2025 Feb 24;80(2):323-330. doi: 10.1093/cid/ciae551.

  PMID: 39523543 DERIVED

• Hammond J, Leister-Tebbe H, Gardner A, Abreu P, Bao W, Wisemandle W, Baniecki M, Hendrick VM, Damle B, Simon-Campos A, Pypstra R, Rusnak JM; EPIC-HR Investigators. Oral Nirmatrelvir for High-Risk, Nonhospitalized Adults with Covid-19. N Engl J Med. 2022 Apr 14;386(15):1397-1408. doi: 10.1056/NEJMoa2118542. Epub 2022 Feb 16.

  PMID: 35172054 DERIVED

Related Links

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

MeSH Terms

Conditions

COVID-19

Interventions

nirmatrelvir; Ritonavir

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: July 10, 2021
• First Posted: July 13, 2021
• Study Start: July 16, 2021
• Primary Completion: December 9, 2021
• Study Completion: April 25, 2022
• Last Updated: July 10, 2025
• Results First Posted: February 9, 2023

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

IN (12); ZA (6); TH (6); AR (2); RU (4); JP (5); BR (3); CO (1); MY (2); HU (5); BU (24); PL (2); CZ (2); PR (2); US (73); ES (2); TU (15); UA (15); KR (4); ME (16)