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 • ClinicalTrials.gov ID: NCT06679140
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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.
Interventions
-
ibuzatrelvir
(Drug)
ibuzatrelvir tablets
-
placebo
(Drug)
placebo tablets
Eligibility criteria
Conditions
Locations
- University of Alabama at Birmingham, Huntsville Regional Medical Campus (HRMC) — Huntsville, Alabama, United States
- Applied Research Center of Arkansas — Little Rock, Arkansas, United States
- National Institute of Clinical Research - Bakersfield — Bakersfield, California, United States
- Velocity Clinical Research, Huntington Park — Huntington Park, 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
- Pacific Clinical Studies Inc. — Los Alamitos, 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
- C & R Research Services USA — Fort Myers, Florida, United States
- Qway Research LLC — Hialeah, Florida, United States
- Sunbright Health Medical Centers — Homestead, Florida, United States
- Infinite Clinical Research — Miami, Florida, United States
- Bio-Medical Research LLC — Miami, Florida, United States
- Kendall South Medical 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 , 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
- Endeavor Health Evanston Hospital — Evanston, Illinois, United States
- Koch Family Medicine — Morton, Illinois, United States
- Endeavor Health Clinical Trials Center — Skokie, Illinois, United States
- Endeavor Health Immediate Care - Old Orchard — Skokie, 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
- Lucida Clinical Trials — New Bedford, 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
- Velocity Clinical Research, Omaha — Omaha, 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
- Monroe Biomedical Research — Monroe, North Carolina, United States
- Remington-Davis, Inc — Columbus, Ohio, United States
- Preferred Primary Care Physicians — Uniontown, Pennsylvania, United States
- Medical University of South Carolina Ashley River Tower — Charleston, South Carolina, United States
- Medical University of South Carolina - SCTR Research Nexus — Charleston, South Carolina, United States
- Medical University of South Carolina — Charleston, South Carolina, 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
- Velocity Clinical Research, Waco — Waco, Texas, United States
- Alpine Research Organization — Clinton, Utah, United States
- Velocity Clinical Research, Suffolk — Suffolk, Virginia, United States
- Sanatorio Guemes — Ciudad de Buenos Aires, Buenos Aires, Argentina
- Instituto Médico Platense (IMP) — La Plata, 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
- Hospital Italiano de Buenos Aires — Buenos Aires, 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
- Centro Avançado de Tratamento Oncológico - CENANTRON — 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
- 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
- i9 Pesquisas Clínicas - Loema Instituto de Pesquisa Clínica e Consultores SS Ltda — 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
- 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
- Lékařský dům v Mezibranské — Prague, Praha 1, Czechia
- Ordinace Hradebni s.r.o. — České Budějovice, South Bohemian Region, Czechia
- Zdravi-fit — Protivín, South Bohemian Region, 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
- Roskilde Sygehus — Roskilde, Region Sjælland, Denmark
- Aalborg Universitetshospital, Syd — Gistrup, 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
- Universitätsklinikum Augsburg — Augsburg, 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
- Universitaetsklinikum Hamburg-Eppendorf — Hamburg, Germany
- University of Rostock — Rostock, 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
- CIMOVA (Consultorio Anexo) — León, Guanajuato, Mexico
- Asociación Mexicana para la Investigación Clínica A.C. — Pachuca, Hidalgo, Mexico
- JM Research SC — Cuernavaca, Morelos, Mexico
- Hospital Universitario "Dr. Jose Eleuterio Gonzalez" — Monterrey, Nuevo León, Mexico
- Eukarya Pharmasite S.C. — Monterrey, Nuevo León, Mexico
- Clinstile, S.A. de C.V. — Mexico City, Mexico
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran — Mexico City, 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
- Synapta Clinical Research Centre — Durban, KwaZulu-Natal, South Africa
- Private Practice - Dr. Peter Sebastian — Silverglen Durban, KwaZulu-Natal, South Africa
- Langeberg Clinical Trials — Cape Town, Western Cape, South Africa
- Paarl Research Centre — Paarl, Western Cape, South Africa
- TREAD Research — Parow, 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, 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)
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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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