Official Title
AN INTERVENTIONAL EFFICACY AND SAFETY, PHASE 2/3, DOUBLE-BLIND, 2 ARM STUDY TO INVESTIGATE ORALLY ADMINISTERED PF 07321332/RITONAVIR COMPARED WITH PLACEBO IN NONHOSPITALIZED SYMPTOMATIC ADULT PARTICIPANTS WITH COVID-19 WHO ARE AT LOW RISK OF PROGRESSING TO SEVERE ILLNESS
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.

Terminated
COVID-19

Drug: PF-07321332

PF-07321332 (tablet)

Drug: Ritonavir

Ritonavir (capsule)

Drug: Placebo

Placebo (tablet)

Drug: Placebo

Placebo (capsule)

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Argentina
Brazil
Bulgaria
Colombia
Czechia
Hungary
Japan
Korea, Republic of
Malaysia
Mexico
Poland
Puerto Rico
Romania
Slovakia
South Africa
Spain
Thailand
Turkey
Ukraine
United States
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

Unlimited Medical Research Group, LLC
Hialeah Gardens, 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

ASCLEPES Research Centers
Lutz, Florida, United States

Pro-Care Research Center, Corp.
Miami Gardens, Florida, United States

Savin Medical Group, LLC
Miami Lakes, 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

Omega Research Orlando, LLC
Orlando, Florida, United States

CDC Research Institute
Port Saint Lucie, Florida, United States

GCP, Global Clinical Professionals
Saint Petersburg, Florida, United States

USPA Advance Concept Medical Research Group LLC
South Miami, Florida, United States

ASCLEPES Research Centers
Spring Hill, 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
Zarate, Buenos Aires, Argentina

Instituto Médico de la Fundación Estudios Clínicos (Fundación Estudios Clínicos)
Rosario, Santa FE, Argentina

Hospital de Clinicas Presidente Nicolas Avellaneda
San Miguel de Tucuman, Tucuman, Argentina

Clinica Mayo Urgencias Medicas Cruz Blanca SRL
San Miguel de Tucuman, Tucuman, Argentina

Hospital Privado Centro Médico de Córdoba
Córdoba, Argentina

Chronos Pesquisa Clinica
Brasilia, Distrito Federal, Brazil

Hospital Agamenon Magalhaes
Recife, Pernambuco, 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

IBPClin - Instituto Brasil de Pesquisa Clínica
Rio de Janeiro, RJ, Brazil

Instituto Nacional de Infectologia Evandro Chagas - INI/FIOCRUZ
Rio de Janeiro, RJ, Brazil

CECOR - Centro Oncológico de Roraima
Boa Vista, Roraima/rr, Brazil

CECIP JAÚ - Centro de Estudos Clínicos do Interior Paulista - LTDA
Jau, SAO Paulo, Brazil

Hospital Dia do Pulmao
Blumenau, SC, Brazil

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

Hospital Alemão Oswaldo Cruz
São Paulo, SP, Brazil

Unidade Referenciada Oswaldo Cruz Vergueiro
São Paulo, SP, Brazil

Clinica de Alergia Martti Antila
Sorocaba, SÃO Paulo, Brazil

CEMEC - Centro Multidisciplinar de Estudos Clínicos
São Bernardo do Campo, 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 -
Ruse, 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
Medellin, Antioquia, Colombia

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

Fundacion Cardiomet Cequin
Armenia, Quindio, Colombia

Zdraví-Fit, s.r.o.
Protivín, Czechia

Nemocnice Slany
Slany, Czechia

Trial Pharma Kft.
Bekescsaba, 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.
Nyiregyhaza, Hungary

International University of Health and Welfare Narita Hospital
Narita, Chiba, Japan

Rakuwakai Otowa Hospital
Kyoto-shi, Kyoto, Japan

Tokyo Shinagawa Hospital
Shinagawa-ku, Tokyo, Japan

Sekino Hospital
Toshimaku, Tokyo, Japan

Kyushu Medical Center
Fukuoka, Japan

Chonnam National University Bitgoeul Hospital
Gwangju, Korea, Republic of

Boramae Medical Center
Seoul, Korea, Republic of

SMG-SNU Boramae Medical Center
Seoul, Korea, Republic of

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 Saltillo S.A. de C.V.
Saltillo, Coahuila, Mexico

Asociación Mexicana para la Investigación Clínica A.C.
Pachuca de Soto, Hidalgo, Mexico

JM Research SC
Cuernavaca, Morelos, Mexico

Christus - Latam Hub Center of Excellence and Innovation Center S.C.
Monterrey, Nuevo LEON, Mexico

Eukarya Pharmasite S.C.
Monterrey, Nuevo LEON, Mexico

Oaxaca Site Management Organization
Oaxaca de Juarez, Oaxaca, Mexico

Köhler & Milstein Research
Merida, Yucatan, Mexico

EME RED Hospitalaria
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
Swidnik, Poland

WIP Warsaw IBD Point Profesor Kierkus
Warszawa, 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
Bucuresti, Romania

HODOSI - MED, s.r.o.
Moldava nad Bodvou, Slovakia

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

Plucna ambulancia Hrebenar, s.r.o.
Spisska Nova Ves, Slovakia

ALERGIA s.r.o.
Topolcany, Slovakia

Global Clinical Trials
Gqeberha, 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

Dr PJ Sebastian Clinical Research Centre
Durban, Kwa-zulu Natal, South Africa

Synapta Clinical Research Center
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

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 Coruna, Spain

Complexo Hospitalario Universitario da Coruna
A Coruña, Spain

Hospital Universitario de la Paz
Madrid, Spain

Hospital Universitario Virgen de Valme
Sevilla, Spain

Siriraj Hospital, Mahidol University
BangkokNoi, Bangkok, Thailand

Riverside Bangkok Hotel
Bangplud, Bangkok, Thailand

Bangkok Centre Hotel
Bangrak, 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, 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

Ankara University Medical Faculty, Ibni-Sina Hospital
Ankara, Turkey

Hacettepe University Medical Faculty Hospital
Ankara, Turkey

Akdeniz Universitesi Hastanesi
Antalya, Turkey

Gaziantep Universitesi Tip Fakultesi Sahinbey Uygulama ve Arastirma Hastanesi
Gaziantep, Turkey

Istanbul University Istanbul Medical Faculty
Istanbul, Turkey

Istanbul University Cerrahpasa-Cerrahpasa Medical Faculty
Istanbul, Turkey

Medipol Mega University Hospital
Istanbul, Turkey

Acibadem University Atakent Hospital
Istanbul, Turkey

Basaksehir Cam ve Sakura Sehir Hastanesi
Istanbul, Turkey

Izmir Suat Seren Chest Disease and Surgery Training and Research Hospital
Izmir, Turkey

Kocaeli University Medical Faculty
Kocaeli, Turkey

Mersin University Medical Faculty
Mersin, Turkey

Sakarya University Training and Research Hospital
Sakarya, Turkey

Karadeniz Teknik Universitesi Farabi Hastanesi
Trabzon, Turkey

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

Pfizer CT.gov Call Center, Study Director
Pfizer

NCT Number
Keywords
SARS-CoV-2 infection
MeSH Terms
COVID-19
Ritonavir
Nirmatrelvir