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RECRUITING
NCT06679140
PHASE3

A Study to Learn About a Study Medicine Called Ibuzatrelvir in Adult and Adolescent Patients With COVID-19 Who Are Not Hospitalized But Are at Risk For Severe Disease

Sponsor: Pfizer

View on ClinicalTrials.gov

Summary

The purpose of the study is to evaluate whether ibuzatrelvir is effective and safe in adults and adolescents with COVID-19 who do not need to be in the hospital but who are at high risk for progression to severe disease. Eligible participants will be randomly assigned (by chance) to receive ibuzatrelvir or matching placebo orally for 5 days. Co-administration of locally available standard of care is allowed. The total duration of the study is around 6 months.

Official title: AN INTERVENTIONAL EFFICACY AND SAFETY, PHASE 3, DOUBLE-BLIND, 2-ARM STUDY TO INVESTIGATE ORALLY ADMINISTERED IBUZATRELVIR COMPARED WITH PLACEBO IN NON-HOSPITALIZED SYMPTOMATIC ADULT AND ADOLESCENT PARTICIPANTS WITH COVID-19 WHO ARE AT HIGH RISK OF PROGRESSING TO SEVERE ILLNESS

Key Details

Gender

All

Age Range

12 Years - Any

Study Type

INTERVENTIONAL

Enrollment

2330

Start Date

2024-12-08

Completion Date

2028-03-02

Last Updated

2026-03-25

Healthy Volunteers

No

Interventions

DRUG

ibuzatrelvir

ibuzatrelvir tablets

DRUG

placebo

placebo tablets

Locations (236)

Applied Research Center of Arkansas

Little Rock, Arkansas, United States

National Institute of Clinical Research - Bakersfield

Bakersfield, California, United States

310 Clinical Research

Inglewood, California, United States

Long Beach Research Institute

Long Beach, California, United States

Long Beach Clinical Trials

Long Beach, California, United States

Downtown L.A. Research Center, Inc.

Los Angeles, California, United States

Clinica mi Salud by Focil Med

Oxnard, California, United States

FOMAT Medical Research

Oxnard, California, United States

Paradigm Clinical Research, LLC

Redding, California, United States

Acclaim Clinical Research

San Diego, California, United States

Tweedy Medical Group - Charity Health

South Gate, California, United States

Breathe Clear Institute for Sinus and Allergy Relief

Torrance, California, United States

Paradigm Clinical Research, LLC

Wheat Ridge, Colorado, United States

Georgetown University Medical Center

Washington D.C., District of Columbia, United States

Emerson Clinical Research Institute

Washington D.C., District of Columbia, United States

Innovative Research of West Florida

Clearwater, Florida, United States

Invictus Clinical Research Group

Coconut Creek, Florida, United States

Hillcrest Medical Research LLC

DeLand, Florida, United States

Hillcrest Medical Research

DeLand, Florida, United States

Universal Axon Clinical Research, LLC

Doral, Florida, United States

Herco Medical and Research Center Inc

Flagami, Florida, United States

Proactive Clinical Research,LLC

Fort Lauderdale, Florida, United States

Qway Research LLC

Hialeah, Florida, United States

Sunbright Health Medical Centers

Homestead, Florida, United States

Bio-Medical Research LLC

Miami, Florida, United States

Kendall South Medical Center

Miami, Florida, United States

Nuovida Research Center

Miami, Florida, United States

Global Health Research Center, Inc.

Miami Lakes, Florida, United States

Adult Medicine of Lake County, Inc.

Mt. Dora, Florida, United States

Innovation Medical Research Center

Palmetto Bay, Florida, United States

DBC Research USA

Pembroke Pines, Florida, United States

GCP Research, Global Clinical professionals

St. Petersburg, Florida, United States

Global Health Research Center - Tampa

Tampa, Florida, United States

The Hope Clinic of Emory University

Decatur, Georgia, United States

Javara - Privia Medical Group Georgia - Fayetteville

Fayetteville, Georgia, United States

Coastal Heritage Clinical Research

Hinesville, Georgia, United States

Velocity Clinical Research, Savannah

Savannah, Georgia, United States

St. Luke's Humphreys Diabetes Center

Boise, Idaho, United States

St. Luke's Children's

Boise, Idaho, United States

St. Luke's Elks Children's Pavilion

Boise, Idaho, United States

Koch Family Medicine

Morton, Illinois, United States

UL International Travel Clinic

Louisville, Kentucky, United States

University of Louisville Hospital

Louisville, Kentucky, United States

University of Louisville School of Medicine

Louisville, Kentucky, United States

Centennial Medical Group

Columbia, Maryland, United States

Jadestone Clinical Research

Silver Spring, Maryland, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

University of Massachusetts Chan Medical School

Worcester, Massachusetts, United States

Revival Research Institute, LLC

Dearborn, Michigan, United States

Henry Ford St. John Hospital

Grosse Pointe Woods, Michigan, United States

Mercury Street Medical Group, PLLC

Butte, Montana, United States

Velocity Clinical Research, Grand Island

Grand Island, Nebraska, United States

McGill Family Practice

Papillion, Nebraska, United States

Las Vegas Clinical Trials

North Las Vegas, Nevada, United States

Upstate Global Health Institute

East Syracuse, New York, United States

Upstate Connect Care

Syracuse, New York, United States

Prime Global Research

The Bronx, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

Monroe Biomedical Research

Monroe, North Carolina, United States

Remington-Davis, Inc

Columbus, Ohio, United States

Preferred Primary Care Physicians

Uniontown, Pennsylvania, United States

WR-Clinsearch, LLC

Chattanooga, Tennessee, United States

Zenos Clinical Research

Dallas, Texas, United States

Southwest Family Medicine Associates

Dallas, Texas, United States

Southwest Mind and Body Care

Dallas, Texas, United States

Memorial Hermann Hospital TMC

Houston, Texas, United States

The University of Texas Health Science Center at Houston

Houston, Texas, United States

UT Physicians

Houston, Texas, United States

Next Level Urgent Care

Houston, Texas, United States

Gulf Coast Clinical Research - Houston

Houston, Texas, United States

Mercury Clinical Research - Santa Clara Family Clinic

Houston, Texas, United States

The Crofoot Research Center

Houston, Texas, United States

Epic Clinical Research

Lewisville, Texas, United States

Javara - Privia Medical Group North Texas - Stephenville

Stephenville, Texas, United States

Javara - Privia Medical Group Gulf Coast - Sugarland

Sugar Land, Texas, United States

Mercury Clinical Research - North Houston Internal Medicine & Pediatric Clinic

Tomball, Texas, United States

Alpine Research Organization

Clinton, Utah, United States

Eastside Research Associates

Redmond, Washington, United States

Sanatorio Guemes

Ciudad de Buenos Aires, Buenos Aires, Argentina

Hospital Italiano de La Plata

La Plata, Buenos Aires, Argentina

Centro de Investigaciones Médicas Mar del Plata

Mar del Plata, Buenos Aires, Argentina

Instituto Médico Río Cuarto

Río Cuarto, Córdoba Province, Argentina

Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L

San Miguel de Tucumán, Tucumán Province, Argentina

Equipo Ciencia

Buenos Aires, Argentina

ANIMA Research

Alken, Limburg, Belgium

Pneumocare

Erpent, Belgium

Hospital Universitario Professor Edgard Santos

Salvador, Estado de Bahia, Brazil

Infection Control

Belo Horizonte, Minas Gerais, Brazil

School of Medicine Federal University of Minas Gerais

Belo Horizonte, Minas Gerais, Brazil

Complexo Hospital de Clínicas da Universidade Federal do Paraná

Curitiba, Paraná, Brazil

Centro Médico São Francisco

Curitiba, Paraná, Brazil

Real Hospital Portugues

Recife, Pernambuco, Brazil

Instituto Atena de Pesquisa Clinica

Natal, Rio Grande do Norte, Brazil

Irmandade da Santa Casa de Misericórdia de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Hospital São Lucas da PUCRS

Porto Alegre, Rio Grande do Sul, Brazil

Centro de Pesquisa Clínica - CPC/UFSM

Santa Maria, Rio Grande do Sul, Brazil

Hospital e Maternidade Celso Pierro

Campinas, São Paulo, Brazil

CECIP - Centro de Estudos do Interior Paulista

Jaú, São Paulo, Brazil

Faculdade de Medicina do ABC

Santo André, São Paulo, Brazil

Centro de Referência e Treinamento DST/AIDS

São Paulo, São Paulo, Brazil

Instituto Nacional de Infectologia Evandro Chagas

Rio de Janeiro, Brazil

Instituto de Infectologia Emilio Ribas

São Paulo, Brazil

Diagnostic Consultative Center - 1 - Sevlievo EOOD

Sevlievo, Gabrovo, Bulgaria

Medical Centre "Asklepiy"

Dupnitsa, Kyustendil, Bulgaria

SHATPD Troyan

Troyan Municipality, Lovech, Bulgaria

Diagnostic Consultative Center - 1 Lom EOOD

Lom, Montana, Bulgaria

MHAT Samokov

Samokov, Sofia, Bulgaria

Military Medical Academy

Sofia, Sofia (stolitsa), Bulgaria

Medical Center Pulmo - 2018 EOOD

Haskovo, Bulgaria

MHAT "Rahila Angelova" Pernik

Pernik, Bulgaria

Diagnostic Consultative Center "Sveti Georgi" Plovdiv

Plovdiv, Bulgaria

Medical Center Sveti Ivan Rilski Chudotvorets - 2010

Plovdiv, Bulgaria

Ambulatory for Individual Primary Medical Care - Dr. Pavlina Petrova - Poli ET

Sofia, Bulgaria

Medical Center Hera EOOD

Sofia, Bulgaria

Medical Center Diana Med 2001

Yambol, Bulgaria

Vancouver Infectious Diseases Centre

Vancouver, British Columbia, Canada

Clinical Research of Ontario

Scarborough Village, Ontario, Canada

Community Care Building

Winchester, Ontario, Canada

Dundas Manor Nursing Home

Winchester, Ontario, Canada

Winchester District Memorial Hospital

Winchester, Ontario, Canada

Diex Recherche Quebec

Québec, Canada

The People's Hospital of Chizhou

Chizhou, Anhui, China

Peking University People's Hospital

Beijing, Beijing Municipality, China

Zhongshan Hospital Fudan University (Xiamen Branch)

Xiamen, Fujian, China

Zhongshan Hospital Xiamen University

Xiamen, Fujian, China

ZhuJiang Hospital of Southern Medical University

Guangzhou, Guangdong, China

The Second Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

The Third Hospital of Changsha

Changsha, Hunan, China

Jiangxi Provincial People's Hospital

Nanchang, Jiangxi, China

The First Hospital of Jilin University

Changchun, Jilin, China

Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Shanghai Children's Medical Center

Shanghai, Shanghai Municipality, China

Shanghai Minhang District Central Hospital

Shanghai, Shanghai Municipality, China

First Affiliated Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

Tianjin First Central Hospital

Tianjin, Tianjin Municipality, China

The First People's Hospital of Yunnan Province

Kunming, Yunnan, China

Sir Run Run Shaw Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Beijing Ditan Hospital Capital Medical

Beijing, China

Doktor Brno

Brno, Brno-město, Czechia

Zdravi-fit

Protivín, Jihočeský kraj, Czechia

MUDr. Petra První s.r.o.

Radomyšl, Jihočeský kraj, Czechia

Praktický lékař Hořiněves

Hořiněves, Královéhradecký kraj, Czechia

Lékařský dům v Mezibranské

Prague, Praha 1, Czechia

Ordinace Hradebni s.r.o.

České Budějovice, Czechia

ORL MUDr Pavel Navratil

Olomouc, Czechia

Rigshospitalet

Copenhagen, Capital Region, Denmark

Nordsjællands Hospital - Hillerød

Hilleroed, Capital Region, Denmark

Regionshospitalet Gødstrup

Herning, Central Jutland, Denmark

Aalborg Universitetshospital, Syd

Aalborg, North Denmark, Denmark

Roskilde Sygehus

Roskilde, Region Sjælland, Denmark

FVR, Oulun rokotetutkimusklinikka

Oulu, North Ostrobothnia, Finland

FVR, Tampereen rokotetutkimusklinikka

Tampere, Pirkanmaa, Finland

FVR, Etelä-Helsingin rokotetutkimusklinikka

Helsinki, Uusimaa, Finland

MeVac - Meilahti Vaccine Research Center

Helsinki, Uusimaa, Finland

LMU Klinikum München

Munich, Bavaria, Germany

Praxisgemeinschaft Heimeranplatz

Munich, Bavaria, Germany

IKF Pneumologie Frankfurt, Clinical Research Center, Departments: Pulmonology, Endocrinology, Cardio

Frankfurt am Main, Hesse, Germany

Studien Rahman & Detho

Obertshausen, Hesse, Germany

Praxis am Ebertplatz

Cologne, North Rhine-Westphalia, Germany

Novopraxis Berlin GbR

Berlin, Germany

zibp Zentrum für lnfektiologie Berlin Prenzlauer Berg GmbH

Berlin, Germany

Charité - Universitätsmedizin Berlin

Berlin, Germany

Universitätsklinik Freiburg

Freiburg im Breisgau, Germany

Kamezawa Clinic

Kasugai, Aichi-ken, Japan

International University of Health and Welfare Narita Hospital

Narita, Chiba, Japan

Tashiro Endocrinology Clinic

Fukuoka, Fukuoka, Japan

Medical Corporation Kouhoukai Takagi Hospital

Okawa-shi, Fukuoka, Japan

Nishioka Hospital

Sapporo, Hokkaido, Japan

Terada Clinic Respiratory Medicine & General Practice

Himeji, Hyōgo, Japan

Koga General Hospital

Koga-shi, Ibaraki, Japan

Tsuchiura Beryl Clinic

Tsuchiura, Ibaraki, Japan

Shonan Fujisawa Tokushukai Hospital

Fujisawa, Kanagawa, Japan

Shonan Kamakura General Hospital

Kamakura, Kanagawa, Japan

Rakuwakai Otowa Hospital

Kyoto, Kyoto, Japan

National Hospital Organization Okinawa Hospital

Ginowan, Okinawa, Japan

Fukuwa Clinic

Chuo-ku, Tokyo, Japan

Musashino Emergency Hospital

Kodaira-shi, Tokyo, Japan

Swing Nozaki Clinic

Musashino-shi, Tokyo, Japan

Yoshijima Hospital

Hiroshima, Japan

Asociación Mexicana para la Investigación Clínica A.C.

Pachuca, Hidalgo, Mexico

JM Research SC

Cuernavaca, Morelos, Mexico

Arké SMO S.A de C.V

Veracruz, Mexico

IRS - Medicinska cinnost s.r.o., Vseobecna ambulancia pre dospelych

Kosice-Juh, Košice Region, Slovakia

Artromac n.o.

Košice, Košice Region, Slovakia

ML MED, s.r.o., Vseobecna ambulancia pre dospelych

Moldava nad Bodvou, Košice Region, Slovakia

Plucna ambulancia Hrebenar, s.r.o., Pneumologicko-ftizeologicka ambulancia

Spišská Nová Ves, Košice Region, Slovakia

PULMO, s.r.o., Pneumologicko-ftizeologicka ambulancia

Prešov, Presov, Slovakia

SALUBER SK s.r.o., Vseobecna ambulancia pre dospelych

Nové Mesto nad Váhom, Trenčín Region, Slovakia

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

Pruské, Trenčín Region, Slovakia

AMB4YOU s.r.o.

Hlohovec, Trnava Region, Slovakia

VL.AK s.r.o. Vseobecna ambulancia pre dospelych

Trnava, Trnava Region, Slovakia

Newtown Clinical Research

Johannesburg, Gauteng, South Africa

Global Clinical Trials

Pretoria, Gauteng, South Africa

Jongaie Research

Pretoria West, Gauteng, South Africa

Sandton Medical Research Centre

Sandton, Gauteng, South Africa

Dr P J Sebastian Clinical Research Centre

Chatsworth, KwaZulu-Natal, South Africa

Synapta Clinical Research Centre

Durban, KwaZulu-Natal, South Africa

TREAD Research

Cape Town, Western Cape, South Africa

Langeberg Clinical Trials

Cape Town, Western Cape, South Africa

Paarl Research Centre

Paarl, Western Cape, South Africa

Incheon Medical Center

Donggu, Incheon-gwangyeoksi [incheon], South Korea

Gachon University Gil Medical Center

Namdong-gu, Incheon-gwangyeoksi [incheon], South Korea

Wonju Severance Christian Hospital

Wŏnju, Kang-won-do, South Korea

Chonnam National University Hospital

Gwangju, Kwangju-kwangyǒkshi, South Korea

Korea University Ansan Hospital

Ansan-si, Kyǒnggi-do, South Korea

Ajou University Hospital

Suwon, Kyǒnggi-do, South Korea

Chung-Ang University Hospital

Dongjak-gu, Seoul-teukbyeolsi [seoul], South Korea

Gangnam Severance Hospital, Yonsei University Health System

Gangnam-gu, Seoul-teukbyeolsi [seoul], South Korea

Korea University Anam Hospital

Seoul, Seoul-teukbyeolsi [seoul], South Korea

The Catholic University of Korea, Eunpyeong St. Mary's Hospital

Seoul, Seoul-teukbyeolsi [seoul], South Korea

Hallym University Kangnam Sacred Heart Hospital

Seoul, Seoul-teukbyeolsi [seoul], South Korea

Korea University Guro Hospital

Seoul, Seoul-teukbyeolsi [seoul], South Korea

Keimyung University Dongsan Hospital

Daegu, Taegu-kwangyǒkshi, South Korea

CHUAC-Complejo Hospitalario Universitario A Coruña

A Coruña, A Coruña [LA Coruña], Spain

Hospital Vithas Xanit Internacional

Benalmádena, Andalusia, Spain

Hospital Universitario Reina Sofia

Córdoba, Andalusia, Spain

Hospital Germans Trias i Pujol

Badalona, Barcelona [barcelona], Spain

Hospital Universitari Vall d'Hebron

Barcelona, Barcelona [barcelona], Spain

Hospital Universitario La Paz

Madrid, Madrid, Comunidad de, Spain

CHUVI- Hospital Alvaro Cunqueiro

Vigo, Pontevedra [pontevedra], Spain

Hospital General Universitario Dr. Balmis

Alicante, Spain

Hospital Universitario Infanta Leonor

Madrid, Spain

Hospital Universitario Virgen de Valme

Seville, Spain

Far Eastern Memorial Hospital

New Taipei City, NEW Taipei, Taiwan

Taichung Veterans General Hospital

Taichung, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

Tri-Service General Hospital

Taipei, Taiwan

Chang Gung Medical Foundation-Linkou Branch

Taoyuan District, Taiwan

Acibadem Universitesi Atakent Hastanesi

Istanbul, İ̇stanbul, Turkey (Türkiye)

Ankara University Ibni Sina Hospital

Ankara, Turkey (Türkiye)

Hacettepe Universite Hastaneleri

Ankara, Turkey (Türkiye)

Ankara Bilkent Şehir Hastanesi

Ankara, Turkey (Türkiye)

Gaziantep Universitesi Sahinbey Arastirma ve Uygulama Hastanesi

Gaziantep, Turkey (Türkiye)

Kocaeli Üniversitesi

Kocaeli, Turkey (Türkiye)

Sakarya Training and Research Hospital

Sakarya, Turkey (Türkiye)

Karadeniz Technical University

Trabzon, Turkey (Türkiye)