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

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

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.

Study Overview

• Status: Terminated
• Conditions: COVID-19
• Intervention / Treatment: Drug: PF-07321332; Drug: Ritonavir; Drug: Placebo; Drug: 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.

• Study Type: Interventional
• Enrollment (Actual): 1440
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Córdoba, Argentina, X5016KEH
    • Hospital Privado Centro Médico de Córdoba
  • Buenos Aires
    • Zarate, Buenos Aires, Argentina, B2800DGH
      • Instituto de Investigaciones Clínicas Zarate
  • Santa FE
    • Rosario, Santa FE, Argentina, 2000
      • Instituto Médico de la Fundación Estudios Clínicos (Fundación Estudios Clínicos)
  • Tucuman
    • San Miguel de Tucuman, Tucuman, Argentina, 4000
      • Hospital de Clinicas Presidente Nicolas Avellaneda
    • San Miguel de Tucuman, Tucuman, Argentina, T4000IHE
      • Clinica Mayo Urgencias Medicas Cruz Blanca SRL
• Brazil
  • São Paulo, Brazil, 01246-900
    • Instituto de Infectologia Emilio Ribas
  • Distrito Federal
    • Brasilia, Distrito Federal, Brazil, 72145-450
      • Chronos Pesquisa Clinica
  • Pernambuco
    • Recife, Pernambuco, Brazil, 52051-380
      • Hospital Agamenon Magalhaes
  • RIO Grande DO Norte
    • Natal, RIO Grande DO Norte, Brazil, 59025-050
      • Centro de Estudos e Pesquisas em Moléstias Infecciosas
  • RIO Grande DO SUL
    • Porto Alegre, RIO Grande DO SUL, Brazil, 90035-903
      • Hospital de Clinicas de Porto Alegre
  • RJ
    • Rio de Janeiro, RJ, Brazil, 20241-180
      • IBPClin - Instituto Brasil de Pesquisa Clínica
    • Rio de Janeiro, RJ, Brazil, 21040-360
      • Instituto Nacional de Infectologia Evandro Chagas - INI/FIOCRUZ
  • Roraima/rr
    • Boa Vista, Roraima/rr, Brazil, 69304-015
      • CECOR - Centro Oncológico de Roraima
  • SAO Paulo
    • Jau, SAO Paulo, Brazil, 17201-130
      • CECIP JAÚ - Centro de Estudos Clínicos do Interior Paulista - LTDA
  • SC
    • Blumenau, SC, Brazil, 89030-101
      • Hospital Dia do Pulmao
  • SP
    • Campinas, SP, Brazil, 13060-904
      • Hospital e Maternidade Celso Pierro - PUC Campinas / Sociedade Campineira de Educação e Instruçã
    • São Paulo, SP, Brazil, 01327-001
      • Hospital Alemao Oswaldo Cruz
    • São Paulo, SP, Brazil, 01508-000
      • Unidade Referenciada Oswaldo Cruz Vergueiro
  • SÃO Paulo
    • Sorocaba, SÃO Paulo, Brazil, 18040-425
      • Clinica de Alergia Martti Antila
    • São Bernardo do Campo, SÃO Paulo, Brazil, 09715-090
      • CEMEC - Centro Multidisciplinar de Estudos Clínicos
• Bulgaria
  • Burgas, Bulgaria, 8001
    • Individual Practice for Primary Medical Care - IPPMC - Dr. P. Panayotov EOOD
  • Haskovo, Bulgaria, 6300
    • "Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases-Haskovo" Ltd
  • Kozloduy, Bulgaria, 3320
    • MHAT "Sv.Ivan. Rilski'' Kozloduy EOOD
  • Lom, Bulgaria, 3600
    • Diagnostic-Consultative Center I Lom EOOD
  • Lom, Bulgaria, 3600
    • Multiprofile Hospital for Active Treatment- Sveti Nikolay Chudotvoretz EOOD
  • Lovech, Bulgaria, 5500
    • Medical Centre Leo Clinic EOOD
  • Pleven, Bulgaria, 5800
    • MHAT Heart and Brain EAD
  • Plovdiv, Bulgaria, 4000
    • DCC Sveti Georgi EOOD
  • Plovdiv, Bulgaria, 4004
    • MHAT "St. Panteleimon "- Plovdiv
  • Razgrad, Bulgaria, 7200
    • Multiprofile Hospital for Active Treatment Sveti Ivan Rilski - Razgrad AD
  • Ruse, Bulgaria, 7002
    • "Specialized Hospital for Active Treatment of Pneumo-Physiatric Diseases Dr. Dimitar Gramatikov -
  • Samokov, Bulgaria, 2000
    • Multiprofile Hospital for Active Treatment - Samokov EOOD
  • Sevlievo, Bulgaria, 5400
    • Medical Center-1-Sevlievo EOOD
  • Sliven, Bulgaria, 8800
    • Multiprofile hospital for active treatment - Sliven to Military Medical Academy
  • Sofia, Bulgaria, 1606
    • UMHATEM N. I. Pirogov EAD
  • Sofia, Bulgaria, 1113
    • Diagnostic-Consultative Center XXII- Sofia ЕООD
  • Sofia, Bulgaria, 1618
    • MHAT "St. Sofia" EOOD
  • Stara Zagora, Bulgaria, 6000
    • Specialized hospital for active treatment in pulmonology and phthisiology "Stara Zagora" EOOD
  • Targovishte, Bulgaria, 7700
    • Multiprofile Hospital for Active Treatment Targovishte AD
  • Tsarevo, Bulgaria, 8260
    • Outpatient Clinic for Primary Outpatient Medical Care "Puls" - Dr. Mladen Buchvarov EOOD
  • Varna, Bulgaria, 9020
    • Medical Center Leo Clinic EOOD
  • Veliko Tarnovo, Bulgaria, 5002
    • MOBAL "D-r Stefan Cherkezov" AD
  • Vratsa, Bulgaria, 3000
    • Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases Vratsa EOOD
• Colombia
  • Antioquia
    • Medellin, Antioquia, Colombia, 050021
      • Fundacion Centro de Investigacion Clinica CIC
  • Cundinamarca
    • Bogota, Cundinamarca, Colombia, 110221
      • Centro de Investigacion en Reumatologia y Especialidades Medicas S.A.S, CIREEM S.A.S
  • Quindio
    • Armenia, Quindio, Colombia, 630004
      • Fundacion Cardiomet Cequin
• Czechia
  • Protivín, Czechia, 398 11
    • Zdravi-fit, s.r.o.
  • Slany, Czechia, 274 01
    • Nemocnice Slany
• Hungary
  • Bekescsaba, Hungary, 5600
    • Trial Pharma Kft.
  • Budapest, Hungary, 1122
    • Semmelweis University Varosmajori Sziv Es Ergyogyaszati Klinika
  • Budapest, Hungary, 1122
    • Varosmajori Sziv- es Ergyogyaszati Klinika
  • Debrecen, Hungary, 4031
    • Debreceni Egyetem Klinikai Kozpont Infektologiai Klinika
  • Eger, Hungary, 3300
    • Agria-Study Kft.
  • Gyula, Hungary, 5700
    • Trial Pharma Kft.
  • Nyiregyhaza, Hungary, 4400
    • Medifarma-98 Kft.
• Japan
  • Fukuoka, Japan, 810-8563
    • Kyushu Medical Center
  • Chiba
    • Narita, Chiba, Japan, 286-8520
      • International University of Health and Welfare Narita Hospital
  • Kyoto
    • Kyoto-shi, Kyoto, Japan, 607-8062
      • Rakuwakai Otowa Hospital
  • Tokyo
    • Shinagawa-ku, Tokyo, Japan, 140-8522
      • Tokyo Shinagawa Hospital
    • Toshimaku, Tokyo, Japan, 171-0014
      • Sekino Hospital
• Korea, Republic of
  • Gwangju, Korea, Republic of, 61748
    • Chonnam National University Bitgoeul Hospital
  • Seoul, Korea, Republic of, 07061
    • SMG-SNU Boramae Medical Center
  • Seoul, Korea, Republic of, 07061
    • Boramae Medical Center
• Malaysia
  • Kelantan
    • Kota Bharu, Kelantan, Malaysia, 15586
      • Hospital Raja Perempuan Zainab II
  • Perak
    • Taiping, Perak, Malaysia, 34000
      • Hospital Taiping
  • Sarawak
    • Miri, Sarawak, Malaysia, 98000
      • Hospital Miri
  • Selangor
    • Rawang, Selangor, Malaysia, 48050
      • Klinik Kesihatan Kuang
• Mexico
  • Durango, Mexico, 34000
    • Instituto de Investigaciones Clínicas para la Salud
  • Veracruz, Mexico, 91900
    • FAICIC Clínical Research
  • Veracruz, Mexico, 91900
    • Sociedad de Metabolismo y Corazón S.C.
  • Coahuila
    • Saltillo, Coahuila, Mexico, 25020
      • Clinical Research Institute S.C.
  • Hidalgo
    • Pachuca de Soto, Hidalgo, Mexico, 42070
      • Asociación Mexicana para la Investigación Clínica A.C.
  • Morelos
    • Cuernavaca, Morelos, Mexico, 62290
      • JM Research SC
  • Nuevo LEON
    • Monterrey, Nuevo LEON, Mexico, 64060
      • Christus - Latam Hub Center of Excellence and Innovation Center S.C.
    • Monterrey, Nuevo LEON, Mexico, 64718
      • Eukarya Pharmasite S.C.
  • Oaxaca
    • Oaxaca de Juarez, Oaxaca, Mexico, 68000
      • Oaxaca Site Management Organization
  • Yucatan
    • Merida, Yucatan, Mexico, 97070
      • Köhler & Milstein Research S.A. de C.V.
  • Yucatán
    • Mérida, Yucatán, Mexico, 97000
      • Eme Red Hospitalaria
• Poland
  • Bialystok, Poland, 15-704
    • Klimed Marek Klimkiewicz
  • Swidnik, Poland, 21-040
    • Tomasz Blicharski Lubelskie Centrum Diagnostyczne
  • Warszawa, Poland, 00-728
    • WIP Warsaw IBD Point Profesor Kierkuś
  • Wroclaw, Poland, 51-162
    • Centrum Badań Klinicznych Piotr Napora Lekarze Spółka Partnerska
• Puerto Rico
  • Ponce, Puerto Rico, 00780
    • Clinical Research Management Group Inc
  • San Juan, Puerto Rico, 00926
    • Advance Medical Research Center
• Romania
  • Bucuresti, Romania, 014142
    • Delta Health Care SRL
• Slovakia
  • Moldava nad Bodvou, Slovakia, 04501
    • HODOSI - MED, s.r.o.
  • Pruske, Slovakia, 018 52
    • MUDr. Viliam Cibik, PhD., s.r.o.
  • Spisska Nova Ves, Slovakia, 052 01
    • Plucna ambulancia Hrebenar, s.r.o.
  • Topolcany, Slovakia, 955 01
    • ALERGIA s.r.o.
• South Africa
  • Eastern CAPE
    • Gqeberha, Eastern CAPE, South Africa, 6014
      • Global Clinical Trials
  • Gauteng
    • Benoni, Gauteng, South Africa, 1500
      • Worthwhile Clinical Trials
    • Boksburg, Gauteng, South Africa, 1475
      • REIMED Vosloorus
    • Johannesburg, Gauteng, South Africa, 1820
      • Lenasia Clinical Trial Centre
    • Pretoria, Gauteng, South Africa, 0184
      • Botho ke Bontle Health Services
    • Pretoria, Gauteng, South Africa, 0186
      • Clinical Trial Systems (Pty) Ltd
    • Sandton, Gauteng, South Africa, 2196
      • Sandton Medical Clinic
    • Vereeniging, Gauteng, South Africa, 1935
      • FCRN Clinical Trial Centre
  • Kwa-zulu Natal
    • Durban, Kwa-zulu Natal, South Africa, 4092
      • Dr PJ Sebastian Clinical Research Centre
  • Kwazulu Natal
    • Durban, Kwazulu Natal, South Africa, 4001
      • Synapta Clinical Research Center
  • Kwazulu-natal
    • Mayville, Durban, Kwazulu-natal, South Africa, 4091
      • Ahmed Al-Kadi Private Hospital
  • Western CAPE
    • George, Western CAPE, South Africa, 6530
      • TASK Eden
    • Paarl, Western CAPE, South Africa, 7626
      • Be Part Research Pty (Ltd)
• Spain
  • A Coruna, Spain, 15006
    • Complexo Hospitalario Universitario da Coruna
  • A Coruña, Spain, 15006
    • Complexo Hospitalario Universitario da Coruna
  • Madrid, Spain, 28046
    • Hospital Universitario de La Paz
  • Sevilla, Spain, 41014
    • Hospital Universitario Virgen de Valme
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Hospital Universitari Germans Trias i Pujol
  • Barcelona [barcelona]
    • Centelles, Barcelona [barcelona], Spain, 08540
      • EBA Centelles
  • Pontevedra
    • Vigo, Pontevedra, Spain, 36312
      • Hospital Álvaro Cunqueiro
  • Valencia
    • Burjassot, Valencia, Spain, 46100
      • IMED Valencia
• Thailand
  • Khon Kaen, Thailand, 40002
    • Srinagarind Hospital
  • Khon Kaen, Thailand, 40002
    • Khon Kaen Univerisity Field Hospital, Student Dormitory 26, Khon Kaen University
  • Bangkok
    • BangkokNoi, Bangkok, Thailand, 10700
      • Siriraj Hospital, Mahidol University
    • Bangplud, Bangkok, Thailand, 10700
      • Riverside Bangkok Hotel
    • Bangrak, Bangkok, Thailand, 10500
      • Bangkok Centre Hotel
    • Pathumwan, Bangkok, Thailand, 10330
      • The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT),
    • Pathumwan,, Bangkok, Thailand, 10330
      • Thai Red Cross Emerging Infectious Diseases (EDI) Clinic
    • Ratchathewi, Bangkok, Thailand, 10400
      • Baiyoke Suite Hotel
  • Songkhla
    • Hat Yai, Songkhla, Thailand, 90110
      • Department of Internal Medicine, Faculty of Medicine, Prince of Songkla University,
• Turkey
  • Ankara, Turkey, 06230
    • Ankara University Medical Faculty, Ibni-Sina Hospital
  • Ankara, Turkey, 06230
    • Hacettepe University Medical Faculty Hospital
  • Antalya, Turkey, 07059
    • Akdeniz Universitesi Hastanesi
  • Gaziantep, Turkey, 27310
    • Gaziantep Universitesi Tip Fakultesi Sahinbey Uygulama ve Arastirma Hastanesi
  • Istanbul, Turkey, 34093
    • Istanbul University Istanbul Medical Faculty
  • Istanbul, Turkey, 34214
    • Medipol Mega University Hospital
  • Istanbul, Turkey, 34098
    • Istanbul University Cerrahpasa-Cerrahpasa Medical Faculty
  • Istanbul, Turkey, 34303
    • Acibadem University Atakent Hospital
  • Istanbul, Turkey, 34480
    • Başakşehir Çam ve Sakura Şehir Hastanesi
  • Izmir, Turkey, 35110
    • Izmir Suat Seren Chest Disease and Surgery Training and Research Hospital
  • Kocaeli, Turkey, 41380
    • Kocaeli University Medical Faculty
  • Mersin, Turkey, 33110
    • Mersin University Medical Faculty
  • Sakarya, Turkey, 54100
    • Sakarya University Training and Research Hospital
  • Trabzon, Turkey, 61080
    • Karadeniz Teknik Üniversitesi Farabi Hastanesi
  • Adana
    • Balcali, Adana, Turkey, 01330
      • Cukurova University Medical Faculty
• Ukraine
  • Chernivtsi, Ukraine, 58001
    • Regional Communal Nonprofit Institution "Chernivtsi Regional Clinical Hospital"
  • Chernivtsi, Ukraine, 58002
    • Communal non-commercial Enterprise "City Clinical Hospital №3" of Chernivtsi City Council
  • Ivano-Frankivsk, Ukraine, 76007
    • Municipal Nonprofit Enterprise "Ivano-Frankivsk Regional Clinical Infectious Diseases Hospital of
  • Ivano-Frankivsk, Ukraine, 76018
    • Municipal Non-profit Enterprise "Ivano-Frankivsk Regional Phthisiopulmonology Center of
  • Ivano-Frankivsk, Ukraine, 76025
    • Communal nonprofit enterprise "Central City Clinical Hospital of Ivano-Frankivsk City Council"
  • Kharkiv, Ukraine, 61096
    • Municipal Nonprofit Enterprise of Kharkiv Regional Council "Regional Clinical Infectious Diseases
  • Kyiv, Ukraine, 01601
    • Municipal Non-profit Enterprise "Oleksandrivska Kyiv City Clinical Hospital" Of Executive Body Of
  • Kyiv, Ukraine, 02091
    • Municipal non-commercial enterprise "Kyiv City Clinical Hospital #1" Of Executive Body Of the Kyiv
  • Kyiv, Ukraine, 03049
    • Kyiv Railway Clinical Hospital No.2 of Branch "Health Center of the Public Joint Stock Company
  • Kyiv, Ukraine, 04050
    • Polyclinic of Center for Medical Services and Rehabilitation of State Joint-Stock Holding Company
  • Lviv, Ukraine, 79011
    • Municipal Nonprofit Enterprise "Lviv City Clinic Hospital #4"
  • Poltava, Ukraine, 36011
    • Municipal Enterprise "Poltava Regional Clinical Infectious Diseases Hospital" of Poltava Regional
  • Vinnytsia, Ukraine, 21029
    • Municipal Non-commercial Enterprise "Vinnytsia City Clinical Hospital №1"
  • Zhytomyr, Ukraine, 10002
    • Communal Enterprise "Hospital #1" of Zhytomyr City Council
• United States
  • Alabama
    • Pelham, Alabama, United States, 35124
      • Cahaba Research Inc
  • Arizona
    • Mesa, Arizona, United States, 85210
      • The Institute for Liver Health dba Arizona Clinical Trials
    • Scottsdale, Arizona, United States, 85258
      • Matrix Mobile Health Clinic #49, #35, and #62
    • Tucson, Arizona, United States, 85712
      • The Institute for Liver Health dba Arizona Clinical Trials
  • California
    • Canoga Park, California, United States, 91303
      • Hope Clinical Research
    • El Segundo, California, United States, 90245
      • Lightship
    • Fullerton, California, United States, 92835
      • Ascada Research
    • La Palma, California, United States, 90623
      • Atella Clinical Research LLC.
    • Long Beach, California, United States, 90806
      • ARK Clinical Research
    • Redondo Beach, California, United States, 90277
      • South Bay Clinical Research Institute
    • Sacramento, California, United States, 95864
      • Benchmark Research
    • San Francisco, California, United States, 94102
      • Optimus Medical Group
    • West Hills, California, United States, 91304
      • Hope Clinical Research (COVID Satellite Site)
  • Colorado
    • Colorado Springs, Colorado, United States, 80907
      • Future Innovative Treatments, LLC
  • Florida
    • Bradenton, Florida, United States, 34208
      • Synergy Healthcare
    • Brandon, Florida, United States, 33511
      • MOORE Clinical Research, Inc.
    • Brandon, Florida, United States, 33511
      • Trueblue Clinical Research
    • Coral Gables, Florida, United States, 33134
      • Herco Medical and Research Center Inc
    • Cutler Bay, Florida, United States, 33157
      • Advance Clinical Research Group
    • Cutler Bay, Florida, United States, 33157
      • Beautiful Minds Clinical Research Center
    • DeBary, Florida, United States, 32713
      • Omega Research Orlando, LLC
    • Hialeah, Florida, United States, 33013
      • Eastern Research Inc
    • Hialeah, Florida, United States, 33013
      • Inpatient Research Clinic
    • Hialeah, Florida, United States, 33016
      • Doral Medical Research, LLC
    • Hialeah Gardens, Florida, United States, 33018
      • Unlimited Medical Research Group, LLC
    • Lutz, Florida, United States, 33549
      • ASCLEPES Research Centers
    • Miami, Florida, United States, 33126
      • LCC Medical Research Institute, LLC
    • Miami, Florida, United States, 33122
      • Angels Clinical Research Institute
    • Miami, Florida, United States, 33126
      • Premium Medical Research Corp
    • Miami, Florida, United States, 33135
      • Global Health Clinical Trials Corp
    • Miami, Florida, United States, 33135
      • South Florida Research Center, Inc.
    • Miami, Florida, United States, 33144
      • I.V.A.M. Clinical & Investigational Center, LLC
    • Miami, Florida, United States, 33174
      • C'A Research
    • Miami, Florida, United States, 33175
      • ProLive Medical Research, Corp.
    • Miami, Florida, United States, 33176
      • Entrust Clinical Research
    • Miami, Florida, United States, 33176
      • Reed Medical Research
    • Miami, Florida, United States, 33185
      • Kendall South Medical Center, Inc.
    • Miami, Florida, United States, 33186
      • Clinical Site Partners, Inc d/b/a CSP Miami
    • Miami, Florida, United States, 33186
      • Coral Research Clinic Corp
    • Miami Gardens, Florida, United States, 33014
      • Pro-Care Research Center, Corp.
    • Miami Lakes, Florida, United States, 33014
      • Savin Medical Group, LLC
    • Orlando, Florida, United States, 32808
      • Omega Research Orlando, LLC
    • Port Saint Lucie, Florida, United States, 34952
      • CDC Research Institute
    • Saint Petersburg, Florida, United States, 33705
      • GCP, Global Clinical Professionals
    • South Miami, Florida, United States, 33143
      • USPA Advance Concept Medical Research Group LLC
    • Spring Hill, Florida, United States, 34609
      • ASCLEPES Research Centers
    • Sunrise, Florida, United States, 33325
      • Sunrise Research Institute
    • Tampa, Florida, United States, 33615
      • Santos Research Center, CORP
    • Winter Park, Florida, United States, 32789
      • Clinical Site Partners, Inc. dba CSP Orlando
  • Iowa
    • Ames, Iowa, United States, 50010
      • McFarland Clinic, PC
    • Ames, Iowa, United States, 50010
      • Accellacare
  • Louisiana
    • Marrero, Louisiana, United States, 70072
      • Tandem Clinical Research GI, LLC
    • Marrero, Louisiana, United States, 70072
      • New Orleans Sinus Center (COVID-19 Testing)
    • Metairie, Louisiana, United States, 70001
      • Southern Clinical Research Associates, LLC
  • Montana
    • Butte, Montana, United States, 59701
      • Mercury Street Medical Group, PLLC
  • Nevada
    • Las Vegas, Nevada, United States, 89109
      • Excel Clinical Research
  • New Mexico
    • Santa Fe, New Mexico, United States, 87505
      • Axces Research Group
  • New York
    • New York, New York, United States, 10037
      • NYC Health + Hospitals / Harlem
  • North Carolina
    • Monroe, North Carolina, United States, 28112
      • Monroe Biomedical Research
    • Wilmington, North Carolina, United States, 28401
      • Accellacare
    • Wilmington, North Carolina, United States, 28401
      • Innovo Research: Wilmington Health
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57105
      • Avera McKennan Hospital & University Health Center
    • Sioux Falls, South Dakota, United States, 57108
      • Avera Research Institute
  • Texas
    • Amarillo, Texas, United States, 79109
      • PharmaTex Research, LLC
    • Austin, Texas, United States, 78745
      • ARC Clinical Research at William Cannon
    • Bellaire, Texas, United States, 77401
      • St Hope Foundation
    • Conroe, Texas, United States, 77304
      • Conroe Willis Medical Research
    • Corpus Christi, Texas, United States, 78413
      • South Texas Clinical Research
    • Houston, Texas, United States, 77057
      • Next Level Urgent Care
    • Houston, Texas, United States, 77008
      • SignatureCare Emergency Center
    • Houston, Texas, United States, 77008
      • Trio Clinical Trials, LLC
    • Pearland, Texas, United States, 77584
      • LinQ Research, LLC
    • Red Oak, Texas, United States, 75154
      • Epic Medical Research
    • San Antonio, Texas, United States, 78229
      • Endeavor Clinical Trials, LLC
    • San Antonio, Texas, United States, 78249
      • BFHC Research
    • Webster, Texas, United States, 77598
      • Tranquility Research
  • Virginia
    • Newport News, Virginia, United States, 23606
      • TMPG Clinical Research
    • Newport News, Virginia, United States, 23606
      • TPMG Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PF-07321332/ritonavir; Orally administered PF-07321332+ritonavir	Drug: PF-07321332; PF-07321332 (tablet); Drug: Ritonavir; Ritonavir (capsule)
Placebo Comparator: Placebo; Orally administered Placebo	Drug: Placebo; Placebo (tablet); Drug: Placebo; Placebo (capsule)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Sustained Alleviation of Overall COVID-19 Signs and Symptoms Through Day 28	Sustained alleviation of targeted COVID-19 signs/symptoms was defined as the event occurring on the first 4 consecutive days when all symptoms scored as moderate or severe at the time of enrollment were scored as mild or absent and those scored mild or absent at the time of enrollment were scored as absent. Missing severity at baseline was considered as mild. Time to sustained alleviation of all targeted COVID-19 signs and symptoms through Day 28, was calculated as time (days) from start of study intervention or placebo (Day 1) until sustained alleviation of all targeted COVID-19 associated signs and symptoms. In this outcome measure time to sustained alleviation is reported consolidated for overall COVID-19 signs and symptoms.	From Day 1 to Day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious AEs and AEs Leading to Study and Study Drug Discontinuation	An AE was defined as any untoward medical occurrence in a participant or clinical study participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening ; required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity ; congenital anomaly/birth defect; or that was considered as an important medical event. TEAEs were defined as events that started on or after the study medication start date and time. AEs included both serious and all non-serious adverse events. AEs that led to study discontinuation and AEs that led to discontinuation of study intervention and then continued study were also reported in this outcome measure.	From start of study intervention (Day 1) up to Day 34
Percentage of Participants With COVID-19 Related Hospitalization or Death From Any Cause Through Day 28	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.	From Day 1 to Day 28
Percentage of Participants With Death Through Week 24	Percentage of participants with death (all-cause) event were reported in this outcome measure.	From Day 1 to Week 24
Number of COVID-19 Related Medical Visits Per Day Through Day 28	Number of COVID-19 related medical visits per day were reported in this outcome measure.	From Day 1 to Day 28
Duration of Hospitalization and Intensive Care Unit (ICU) Stay Through Day 28		From Day 1 to Day 28
Percentage of Participants With Severe Signs and Symptoms of COVID-19 Through Day 28	Participants recorded a daily severity rating of their symptom severity over the past 24 hours based on a 4-point scale in which 0 was reported if no symptoms were present; 1 if mild; 2 if moderate; and 3 if severe. A participant with severe score for any targeted symptoms post-baseline was counted as severe. Vomiting and diarrhea each was rated on a 4-point frequency scale where 0 was reported for no occurrence, 1 for 1 to 2 times, 2 for 3 to 4 times, and 3 for 5 or greater. Sense of smell and sense of taste each be rated on a 3-point Likert scale where 0 was reported if the sense of smell/taste was the same as usual, 1 if the sense of smell/taste was less than usual, and 2 for no sense of smell/taste.	From Day 1 to Day 28
Time to Sustained Resolution of Overall COVID-19 Signs and Symptoms Through Day 28	Sustained resolution was defined as when targeted symptoms are scored as absent for 4 consecutive days. The first day of the 4 consecutive-day period was considered the first event date.	From Day 1 to Day 28
Time to Sustained Alleviation of Each COVID-19 Signs and Symptoms Through Day 28	Sustained alleviation of targeted COVID-19 signs/symptoms was defined as the event occurring on the first 4 consecutive days when all symptoms scored as moderate or severe at the time of enrollment were scored as mild or absent and those scored mild or absent at the time of enrollment were scored as absent. Missing severity at baseline was treated as mild. Time to sustained alleviation of all targeted COVID-19 signs and symptoms through Day 28, was calculated as time (days) from start of study intervention or placebo (Day 1) until sustained alleviation of all targeted COVID-19 associated signs and symptoms. In this outcome measure time to sustained alleviation is reported for each COVID-19 signs and symptoms.	From Day 1 to Day 28
Time to Sustained Resolution of Each COVID-19 Signs and Symptoms Through Day 28	Sustained resolution was defined as when targeted symptoms are scored as absent for 4 consecutive days. The first day of the 4 consecutive-day period was considered the first event date. In this outcome measure time to sustained resolution is reported consolidated for each COVID-19 signs and symptoms.	From Day 1 to Day 28
Percentage of Participants With Progression to Worsening Status of COVID-19 Signs and Symptoms	Participants recorded a daily severity rating of their symptom severity over the past 24 hours based on a 4-point scale in which 0 was reported if no symptoms were present; 1 if mild; 2 if moderate; and 3 if severe. Vomiting and diarrhea was rated on a 4-point frequency scale where 0 is reported for no occurrence, 1 (mild) for 1 to 2 times, 2 (moderate) for 3 to 4 times, and 3 (severe) for 5 or greater. Progression to a worsening status for any targeted symptom was based up on increasing severity (i.e. the first time any targeted symptoms worsened after treatment relative to baseline).	From Day 1 to Day 28
Percentage of Participants With Resting Peripheral Oxygen Saturation Greater Than or Equal to (>=) 95% at Day 1 and Day 5	Percentage of participants with a resting peripheral oxygen saturation >=95% were reported in this outcome measure.	Day 1 and Day 5
Plasma Concentration Versus Time Summary of PF-07321332		Day 1: 1 hour post dose; Day 5: 0 minutes pre-dose
Change From Baseline in Logarithm to Base10 (Log10) Transformed Viral Load at Days 3, 5, 10 and 14	Nasal samples were collected to estimate the viral load in participants in terms of logarithm to base 10 (log10) copies per milliliter.	Baseline, Days 3, 5, 10 and 14

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2021
• Primary Completion (Actual): July 25, 2022
• Study Completion (Actual): July 25, 2022

Study Registration Dates

• First Submitted: July 30, 2021
• First Submitted That Met QC Criteria: August 16, 2021
• First Posted (Actual): August 18, 2021

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: July 20, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: SARS-CoV-2 Infection
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Protease Inhibitors; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; HIV Protease Inhibitors; Viral Protease Inhibitors; Ritonavir; Nirmatrelvir
• Other Study ID Numbers: C4671002; 2021-002857-28 (EudraCT Number); EPIC-SR (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No