EPIC-HR: Study of Oral PF-07321332/Ritonavir Compared With Placebo in Nonhospitalized High Risk Adults With COVID-19 | NCT04960202 | Trialant

EPIC-HR: Study of Oral PF-07321332/Ritonavir Compared With Placebo in Nonhospitalized High Risk Adults With COVID-19 | NCT04960202 | Trialant

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility Criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Cahaba Research Inc

Pelham, Alabama 35124, United States

The Institute for Liver Health dba Arizona Clinical Trials

Mesa, Arizona 85210, United States

The Institute for Liver Health dba Arizona Clinical Trials

Tucson, Arizona 85712, United States

Hope Clinical Research

Canoga Park, California 91303, United States

Ascada Research

Fullerton, California 92835, United States

Atella Clinical Research LLC.

La Palma, California 90623, United States

Ark Clinical Research

Long Beach, California 90806, United States

American Institute of Research

Los Angeles, California 90017, United States

South Bay Clinical Research Institute

Redondo Beach, California 90277, United States

Hope Clinical Research (COVID Satellite Site)

West Hills, California 91304, United States

Future Innovative Treatments, LLC

Colorado Springs, Colorado 80907, United States

Xera Med Research

Boca Raton, Florida 33487, United States

MOORE Clinical Research, Inc.

Brandon, Florida 33511, United States

Innovative Research of West Florida, Inc.

Clearwater, Florida 33756, United States

Herco Medical and Research Center Inc

Coral Gables, Florida 33134, United States

Advance Clinical Research Group

Cutler Bay, Florida 33157, United States

Beautiful Minds Clinical Research Center

Cutler Bay, Florida 33157, United States

Qway Research

Hialeah, Florida 33010, United States

Eastern Research Inc

Hialeah, Florida 33013, United States

Inpatient Research Clinic

Hialeah, Florida 33013, United States

Doral Medical Research LLC.

Hialeah, Florida 33016, United States

Doral Medical Research,LLC

Hialeah, Florida 33016, United States

Unlimited Medical Research Group, LLC

Hialeah Gardens, Florida 33018, United States

Advanced Pulmonary Research Institute

Loxahatchee Groves, Florida 33470, United States

Angels Clinical Research Institute

Miami, Florida 33122, United States

LCC Medical Research Institute, LLC

Miami, Florida 33126, United States

Premium Medical Research Corp

Miami, Florida 33126, United States

Global Health Clinical Trials Corp

Miami, Florida 33135, United States

South Florida Research Center, Inc.

Miami, Florida 33135, United States

Suncoast Research Group, LLC

Miami, Florida 33135, United States

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

Miami, Florida 33144, United States

C'A Research

Miami, Florida 33174, United States

ProLive Medical Research, Corp.

Miami, Florida 33175, United States

Entrust Clinical Research

Miami, Florida 33176, United States

Reed Medical Research

Miami, Florida 33176, United States

Kendall South Medical Center

Miami, Florida 33185, United States

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

Miami, Florida 33186, United States

Coral Research Clinic Corp

Miami, Florida 33186, United States

Savin Medical Group, LLC

Miami Lakes, Florida 33014, United States

Omega Research Orlando, LLC

Orlando, Florida 32808, United States

NAPA Research LLC

Pompano Beach, Florida 33064, United States

CDC Research Institute

Port Saint Lucie, Florida 34952, United States

USPA Advance Concept Medical Research Group LLC

South Miami, Florida 33143, United States

GCP, Global Clinical Professionals

St. Petersburg, Florida 33705, United States

Sunrise Research Institute

Sunrise, Florida 33325, United States

Santos Research Center, CORP

Tampa, Florida 33615, United States

Clinical Site Partners, Inc. dba CSP Orlando

Winter Park, Florida 32789, United States

Research by Design, LLC

Chicago, Illinois 60643, United States

New Orleans Sinus Center (COVID-19 Testing)

Marrero, Louisiana 70072, United States

Tandem Clinical Research GI, LLC

Marrero, Louisiana 70072, United States

Mercury Street Medical Group, PLLC

Butte, Montana 59701, United States

Excel Clinical research

Las Vegas, Nevada 89109, United States

Meridian Clinical Research, LLC

Endwell, New York 13760, United States

Monroe Biomedical Research

Monroe, North Carolina 28112, United States

Accellacare

Wilmington, North Carolina 28401, United States

Premier Medical Group

Clarksville, Tennessee 37040, United States

PharmaTex Research, LLC

Amarillo, Texas 79109, United States

ARC Clinical Research at William Cannon

Austin, Texas 78745, United States

St Hope Foundation

Bellaire, Texas 77401, United States

Conroe Willis Medical Research

Conroe, Texas 77304, United States

South Texas Clinical Research

Corpus Christi, Texas 78413, United States

SignatureCare Emergency Center

Houston, Texas 77008, United States

Trio Clinical Trials, LLC

Houston, Texas 77008, United States

C & R Research Services USA

Houston, Texas 77022, United States

Next Level Urgent Care

Houston, Texas 77057, United States

SMS Clinical Research, LLC

Mesquite, Texas 75149, United States

SMS Clinical Research

Mesquite, Texas 75149, United States

LinQ Research, LLC

Pearland, Texas 77584, United States

Epic Medical Research

Red Oak, Texas 75154, United States

Sun Research Institute

San Antonio, Texas 78215, United States

BFHC Research

San Antonio, Texas 78249, United States

Tranquility Research

Webster, Texas 77598, United States

TPMG (Tidewater Physicians Multispecialty Group) Clinical Research

Newport News, Virginia 23606, United States

Instituto de Investigaciones Clinicas Zarate

Zárate, Buenos Aires B2800DGH, Argentina

Hospital De Clínicas Presidente Dr.Nicolas Avellaneda

San Miguel de Tucumán, Tucumán Province 4000, Argentina

Chronos Pesquisa Clinica

Brasília, Federal District 72145-450, Brazil

Hospital Agamenon Magalhaes

Recife, Pernambuco 52051-380, Brazil

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

Jaú, São Paulo 17201-130, Brazil

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

Burgas, 8001, Bulgaria

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

Haskovo, 6300, Bulgaria

MHAT "Sv.Ivan. Rilski'' Kozloduy EOOD

Kozloduy, 3320, Bulgaria

Diagnostic-Consultative Center I Lom EOOD

Lom, 3600, Bulgaria

Multiprofile Hospital for Active Treatment- Sveti Nikolay Chudotvoretz EOOD

Lom, 3600, Bulgaria

Medical centre Leo Clinic EOOD

Lovech, 5500, Bulgaria

MHAT Heart and Brain EAD

Pleven, 5800, Bulgaria

DCC Sveti Georgi EOOD

Plovdiv, 4000, Bulgaria

MHAT "St. Panteleimon "- Plovdiv

Plovdiv, 4004, Bulgaria

Multiprofile Hospital for Active Treatment Sveti Ivan Rilski - Razgrad AD

Razgrad, 7200, Bulgaria

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

Rousse, 7002, Bulgaria

UMHAT Medica Ruse OOD

Rousse, 7013, Bulgaria

Multiprofile Hospital for Active Treatment - Samokov EOOD

Samokov, 2000, Bulgaria

Medical Center-1-Sevlievo EOOD

Sevlievo, 5400, Bulgaria

Multiprofile Hospital For Active Treatment Shumen AD

Shumen, 9700, Bulgaria

Multiprofile hospital for active treatment - Sliven to Military Medical Academy

Sliven, 8800, Bulgaria

MHAT "Dr. Ivan Seliminski" AD, Sliven

Sliven, 8801, Bulgaria

Diagnostic-Consultative Center XXII- Sofia ЕООD

Sofia, 1113, Bulgaria

MHAT "St. Sofia" EOOD

Sofia, 1618, Bulgaria

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

Stara Zagora, 6000, Bulgaria

Multiprofile Hospital for Active Treatment Targovishte AD

Targovishte, 7700, Bulgaria

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

Tsarevo, 8260, Bulgaria

Medical center Leo Clinic EOOD

Varna, 9020, Bulgaria

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

Vratsa, 3000, Bulgaria

Fundacion Cardiomet Cequin

Armenia, Quindío Department 630004, Colombia

Zdraví-Fit, s.r.o.

Protivín, 398 11, Czechia

Nemocnice Slany

Slaný, 274 01, Czechia

Trial Pharma Kft.

Békéscsaba, 5600, Hungary

Debreceni Egyetem Klinikai Kozpont Infektologiai Klinika

Debrecen, 4031, Hungary

Agria-Study Kft.

Eger, 3300, Hungary

Trial Pharma Kft.

Gyula, 5700, Hungary

Medifarma-98 Kft.

Nyíregyháza, 4400, Hungary

AIIMS Raipur

Raipur, Chhattisgarh 492099, India

Jupiter Hospital

Vadodara, Gujarat 390012, India

BGS Global Institute of Medical Sciences and Hospital

Bangalore, Karnataka 560060, India

Lisie Hospital

Kochi, Kerala 682018, India

Jehangir Clinical Development Centre Pvt. Ltd

Pune, Maharashtra 411001, India

Lifepoint Research LLP

Pune, Maharashtra 411057, India

Jawahar Lal Nehru Medical College

Ajmer, Rajasthan 305001, India

Apex Hospitals Pvt Ltd

Jaipur, Rajasthan 302017, India

Maharaja Agrasen Superspeciality Hospital

Jaipur, Rajasthan 302039, India

Nil Ratan Sircar Medical College and Hospital

Kolkata, West Bengal 700014, India

Aakash Healthcare Private Limited

New Delhi, 110075, India

Sardar Patel Medical College

Pavan PURI Bikaner, Rajasthan, 334003, India

International University of Health and Welfare Narita Hospital

Narita, Chiba 286-8520, Japan

National Hokkaido Medical Center

Sapporo, Hokkaido 063-0005, Japan

Rinku General Medical Center

Izumisano, Osaka 598-8577, Japan

Tokyo Medical University Hachioji Medical Center

Hachiōji, Tokyo 1930998, Japan

National Center for Global Health and Medicine

Shinjuku, Tokyo 162-8655, Japan

Hospital Umum Sarawak

Kuching, Sarawak 93586, Malaysia

Hospital Miri

Miri, Sarawak 98000, Malaysia

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

Saltillo, Coahuila 25020, Mexico

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

Pachuca, Hidalgo 42070, Mexico

Instituto Jalisciense de Metabolismo, S.C.

Guadalajara, Jalisco 44670, Mexico

JM Research SC

Cuernavaca, Morelos 62290, Mexico

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

Monterrey, Nuevo León 64060, Mexico

Eukarya Pharmasite S.C.

Monterrey, Nuevo León 64718, Mexico

Oaxaca Site Management Organization

Oaxaca City, Oaxaca 68000, Mexico

InfectoLab Consultorios de Especialidad en Infectologia

Baja California, Tijuana 22010, Mexico

EME RED Hospitalaria

Mérida, Yucatán 97000, Mexico

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

Mérida, Yucatán 97070, Mexico

Centro de Investigacion Clinica Del Pacifico SA de CV

Acapulco, Mexico

Hospital Cardiologica Aguascalientes

Aguascalientes, CP 201230, Mexico

Instituto de Investigaciones Clínicas para la Salud

Durango, 34000, Mexico

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

Veracruz, 91900, Mexico

Sociedad de Metabolismo y Corazon S.C.

Veracruz, 91900, Mexico

Arké SMO S.A de C.V

Veracruz, 91910, Mexico

KLIMED Marek Klimkiewicz

Bialystok, 15-704, Poland

Centrum Badań Klinicznych Piotr Napora Lekarze Spółka Partnerska

Wroclaw, 51-162, Poland

Clinical Research Management Group Inc

Ponce, 00780, Puerto Rico

Advance Medical Research Center

San Juan, 00926, Puerto Rico

LLC Trekhgorka Medicine

Odintsovo, Moscow Oblast 143005, Russia

Barnaul City Hospital Number 5

Barnaul, 656045, Russia

KDC "Evromedservis", OJSC

Moscow, 115419, Russia

Smolensk State Medical University

Smolensk, 214019, Russia

MERC Welkom

Welkom, Free State 9460, South Africa

East Rand Research Centre T/A Worthwhile Clinical Trials

Benoni, Gauteng 1500, South Africa

Botho Ke Bontle Health Services

Pretoria, Gauteng 0122, South Africa

Synapta Clinical Research Center

Durban, KwaZulu-Natal 4001, South Africa

Limpopo Clinical Research Initiative

Thabazimbi, Limpopo 0380, South Africa

MERC Middelburg

Middelburg, Mpumalanga 1055, South Africa

Kyungpook National University Chilgok Hospital

Daegu, 41404, South Korea

Incheon Medical Center

Incheon, 22532, South Korea

Chonnam National University Bitgoeul Hospital

Nam-gu, 61748, South Korea

SMG-SNU Boramae Medical Center

Seoul, 07061, South Korea

Eba Centelles

Centelles, Barcelona [barcelona] 08540, Spain

Complexo Hospitalario Universitario da Coruna

A Coruña, 15006, Spain

Bangkok Centre Hotel

Bang Rak, Bangkok 10500, Thailand

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

Pathum Wan District,, Bangkok 10330, Thailand

Thai Red Cross Emerging Infectious Diseases (EDI) Clinic

Pathumwan,, Bangkok 10330, Thailand

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

Pathumwan, Bangkok 10330, Thailand

Faculty of Medicine - Khon Kaen University

Muang, Changwat Khon Kaen 40002, Thailand

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

Hat Yai, Changwat Songkhla 90110, Thailand

Ankara University Medical Faculty, Ibni-Sina Hospital

Ankara, 06230, Turkey (Türkiye)

Hacettepe University Medical Faculty Hospital

Ankara, 06230, Turkey (Türkiye)

Akdeniz Universitesi Hastanesi

Antalya, 07059, Turkey (Türkiye)

Istanbul Medipol University Clinical Research Ethics Committee

Beykoz / Istanbul, 34810, Turkey (Türkiye)

Gaziantep University Medical Faculty

Gaziantep, 27300, Turkey (Türkiye)

Istanbul Yedikule Gogus Hastaliklari ve Gogus Cerrahisi Egitim Arastirma Hastanesi

Istanbul, 34020, Turkey (Türkiye)

Istanbul University Cerrahpasa-Cerrahpasa Medical Faculty

Istanbul, 34098, Turkey (Türkiye)

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

Istanbul, 34303, Turkey (Türkiye)

Istanbul Universitesi Klinik Arastirmalar Mukemmeliyet Uygulama ve Arastirma Merkezi

Istanbul, 34452, Turkey (Türkiye)

Basaksehir Cam ve Sakura Sehir Hastanesi

Istanbul, 34480, Turkey (Türkiye)

Kocaeli University Medical Faculty

Kocaeli, 41380, Turkey (Türkiye)

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

Konak/Izmir, 35170, Turkey (Türkiye)

Mersin University Health Research and Application Hospital

Mersin, 33110, Turkey (Türkiye)

Sakarya University Training and Research Hospital

Sakarya, 54100, Turkey (Türkiye)

Karadeniz Teknik Universitesi Farabi Hastanesi

Trabzon, 61080, Turkey (Türkiye)

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

Dnipro, 49069, Ukraine

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

Ivano-Frankivsk, 76007, Ukraine

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

Ivano-Frankivsk, 76018, Ukraine

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

Kharkiv, 61002, Ukraine

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

Kharkiv, 61096, Ukraine

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

Kyiv, 01601, Ukraine

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

Kyiv, 02091, Ukraine

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

Kyiv, 03049, Ukraine

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

Kyiv, 04050, Ukraine

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

Lviv, 79008, Ukraine

Municipal Nonprofit Enterprise "Lviv City Clinic Hospital #4"

Lviv, 79011, Ukraine

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

Poltava, 36011, Ukraine

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

Tarasove Village, 45625, Ukraine

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

Vinnytsia, 21029, Ukraine

Communal Enterprise "Hospital #1" of Zhytomyr City Council

Zhytomyr, 10002, Ukraine