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
Start Date
12/8/2024
Completion Date
3/2/2028
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.
Eligibility Criteria
Age Range: 12 years to No maximum
Interventions
ibuzatrelvir
placebo
Conditions
Locations
Applied Research Center of Arkansas
Little Rock, Arkansas 72205
United States
National Institute of Clinical Research - Bakersfield
Bakersfield, California 93309
United States
Velocity Clinical Research, Huntington Park
Huntington Park, California 90255
United States
310 Clinical Research
Inglewood, California 90301
United States
Long Beach Research Institute
Long Beach, California 90805
United States
Long Beach Clinical Trials
Long Beach, California 90806
United States
Pacific Clinical Studies Inc.
Los Alamitos, California 90720
United States
Downtown L.A. Research Center, Inc.
Los Angeles, California 90017
United States
Clinica mi Salud by Focil Med
Oxnard, California 93030
United States
FOMAT Medical Research
Oxnard, California 93030
United States
Paradigm Clinical Research, LLC
Redding, California 96001
United States
Acclaim Clinical Research
San Diego, California 92120
United States
Tweedy Medical Group - Charity Health
South Gate, California 90280
United States
Breathe Clear Institute for Sinus and Allergy Relief
Torrance, California 90503
United States
Paradigm Clinical Research, LLC
Wheat Ridge, Colorado 80033
United States
Georgetown University Medical Center
Washington D.C., District of Columbia 20007
United States
Emerson Clinical Research Institute
Washington D.C., District of Columbia 20009
United States
Innovative Research of West Florida
Clearwater, Florida 33756
United States
Invictus Clinical Research Group
Coconut Creek, Florida 33073
United States
Hillcrest Medical Research LLC
DeLand, Florida 32720
United States
Hillcrest Medical Research
DeLand, Florida 32720
United States
Universal Axon Clinical Research, LLC
Doral, Florida 33166
United States
Herco Medical and Research Center Inc
Flagami, Florida 33126
United States
Proactive Clinical Research,LLC
Fort Lauderdale, Florida 33308
United States
C & R Research Services USA
Fort Myers, Florida 33919
United States
Qway Research LLC
Hialeah, Florida 33010
United States
Sunbright Health Medical Centers
Homestead, Florida 33032
United States
Infinite Clinical Research
Miami, Florida 33133
United States
Bio-Medical Research LLC
Miami, Florida 33144
United States
Kendall South Medical Center
Miami, Florida 33185
United States
Nuovida Research Center
Miami, Florida 33186
United States
Global Health Research Center, Inc.
Miami Lakes, Florida 33016
United States
Adult Medicine of Lake County, Inc.
Mt. Dora, Florida 32757
United States
Innovation Medical Research Center
Palmetto Bay, Florida 33157
United States
DBC Research USA
Pembroke Pines, Florida 33029
United States
GCP , Global Clinical Professionals
St. Petersburg, Florida 33714
United States
Global Health Research Center - Tampa
Tampa, Florida 33615
United States
The Hope Clinic of Emory University
Decatur, Georgia 30030
United States
Javara - Privia Medical Group Georgia - Fayetteville
Fayetteville, Georgia 30214
United States
Coastal Heritage Clinical Research
Hinesville, Georgia 31313
United States
Velocity Clinical Research, Savannah
Savannah, Georgia 31406
United States
St. Luke's Humphreys Diabetes Center
Boise, Idaho 83702
United States
St. Luke's Children's
Boise, Idaho 83712
United States
St. Luke's Elks Children's Pavilion
Boise, Idaho 83712
United States
Koch Family Medicine
Morton, Illinois 61550
United States
UL International Travel Clinic
Louisville, Kentucky 40202
United States
University of Louisville Hospital
Louisville, Kentucky 40202
United States
University of Louisville School of Medicine
Louisville, Kentucky 40202
United States
Centennial Medical Group
Columbia, Maryland 21045
United States
Jadestone Clinical Research
Silver Spring, Maryland 20904
United States
Brigham and Women's Hospital
Boston, Massachusetts 02115
United States
University of Massachusetts Chan Medical School
Worcester, Massachusetts 01655
United States
Revival Research Institute, LLC
Dearborn, Michigan 48126
United States
Henry Ford St. John Hospital
Grosse Pointe Woods, Michigan 48236
United States
Mercury Street Medical Group, PLLC
Butte, Montana 59701
United States
Velocity Clinical Research, Grand Island
Grand Island, Nebraska 68803
United States
Velocity Clinical Research, Omaha
Omaha, Nebraska 68134
United States
McGill Family Practice
Papillion, Nebraska 68046
United States
Las Vegas Clinical Trials
North Las Vegas, Nevada 89030
United States
Upstate Global Health Institute
East Syracuse, New York 13057
United States
Upstate Connect Care
Syracuse, New York 13210
United States
Prime Global Research
The Bronx, New York 10456
United States
Monroe Biomedical Research
Monroe, North Carolina 28112
United States
Remington-Davis, Inc
Columbus, Ohio 43215
United States
Preferred Primary Care Physicians
Uniontown, Pennsylvania 15401
United States
Medical University of South Carolina Ashley River Tower
Charleston, South Carolina 29401
United States
Medical University of South Carolina - SCTR Research Nexus
Charleston, South Carolina 29425
United States
Medical University of South Carolina
Charleston, South Carolina 29425
United States
WR-Clinsearch, LLC
Chattanooga, Tennessee 37421
United States
Zenos Clinical Research
Dallas, Texas 75230
United States
Southwest Family Medicine Associates
Dallas, Texas 75235
United States
Southwest Mind and Body Care
Dallas, Texas 75235
United States
Memorial Hermann Hospital TMC
Houston, Texas 77030
United States
The University of Texas Health Science Center at Houston
Houston, Texas 77030
United States
UT Physicians
Houston, Texas 77030
United States
Next Level Urgent Care
Houston, Texas 77057
United States
Gulf Coast Clinical Research - Houston
Houston, Texas 77070
United States
Mercury Clinical Research - Santa Clara Family Clinic
Houston, Texas 77087
United States
The Crofoot Research Center
Houston, Texas 77098
United States
Epic Clinical Research
Lewisville, Texas 75057
United States
Javara - Privia Medical Group North Texas - Stephenville
Stephenville, Texas 76401
United States
Javara - Privia Medical Group Gulf Coast - Sugarland
Sugar Land, Texas 77478
United States
Mercury Clinical Research - North Houston Internal Medicine & Pediatric Clinic
Tomball, Texas 77375
United States
Velocity Clinical Research, Waco
Waco, Texas 76710
United States
Alpine Research Organization
Clinton, Utah 84015
United States
Velocity Clinical Research, Suffolk
Suffolk, Virginia 23435
United States
Eastside Research Associates
Redmond, Washington 98052
United States
Sanatorio Guemes
Ciudad de Buenos Aires, Buenos Aires 1180
Argentina
Instituto Médico Platense (IMP)
La Plata, Buenos Aires B1900AVG
Argentina
Hospital Italiano de La Plata
La Plata, Buenos Aires B1900XI
Argentina
Centro de Investigaciones Médicas Mar del Plata
Mar del Plata, Buenos Aires 7600
Argentina
Instituto Médico Río Cuarto
Río Cuarto, Córdoba Province X5800
Argentina
Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L
San Miguel de Tucumán, Tucumán Province 4000
Argentina
Hospital Italiano de Buenos Aires
Buenos Aires, C1199ABB
Argentina
Equipo Ciencia
Buenos Aires, C1428BNF
Argentina
ANIMA Research
Alken, Limburg 3570
Belgium
Pneumocare
Erpent, 5101
Belgium
Hospital Universitario Professor Edgard Santos
Salvador, Estado de Bahia 40110-060
Brazil
Infection Control
Belo Horizonte, Minas Gerais 30110-945
Brazil
Centro Avançado de Tratamento Oncológico - CENANTRON
Belo Horizonte, Minas Gerais 30130-090
Brazil
School of Medicine Federal University of Minas Gerais
Belo Horizonte, Minas Gerais 30130-100
Brazil
Complexo Hospital de Clínicas da Universidade Federal do Paraná
Curitiba, Paraná 80.060-900
Brazil
Centro Médico São Francisco
Curitiba, Paraná 80810-050
Brazil
Real Hospital Portugues
Recife, Pernambuco 52010-075
Brazil
Instituto Atena de Pesquisa Clinica
Natal, Rio Grande do Norte 59020-500
Brazil
Irmandade da Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, Rio Grande do Sul 90020-090
Brazil
Hospital São Lucas da PUCRS
Porto Alegre, Rio Grande do Sul 90610000
Brazil
Centro de Pesquisa Clínica - CPC/UFSM
Santa Maria, Rio Grande do Sul 97060-360
Brazil
Hospital e Maternidade Celso Pierro
Campinas, São Paulo 13060-803
Brazil
i9 Pesquisas Clínicas - Loema Instituto de Pesquisa Clínica e Consultores SS Ltda
Campinas, São Paulo 13092-133
Brazil
CECIP - Centro de Estudos do Interior Paulista
Jaú, São Paulo 17201130
Brazil
Faculdade de Medicina do ABC
Santo André, São Paulo 09060-870
Brazil
Centro de Referência e Treinamento DST/AIDS
São Paulo, São Paulo 04121-000
Brazil
Instituto Nacional de Infectologia Evandro Chagas
Rio de Janeiro, 21040-360
Brazil
Instituto de Infectologia Emilio Ribas
São Paulo, 01246900
Brazil
Diagnostic Consultative Center - 1 - Sevlievo EOOD
Sevlievo, Gabrovo 5400
Bulgaria
Medical Centre "Asklepiy"
Dupnitsa, Kyustendil 2600
Bulgaria
SHATPD Troyan
Troyan Municipality, Lovech 5600
Bulgaria
Diagnostic Consultative Center - 1 Lom EOOD
Lom, Montana 3600
Bulgaria
MHAT Samokov
Samokov, Sofia 2000
Bulgaria
Military Medical Academy
Sofia, Sofia (stolitsa) 1606
Bulgaria
Medical Center Pulmo - 2018 EOOD
Haskovo, 6300
Bulgaria
MHAT "Rahila Angelova" Pernik
Pernik, 2300
Bulgaria
Diagnostic Consultative Center "Sveti Georgi" Plovdiv
Plovdiv, 4000
Bulgaria
Medical Center Sveti Ivan Rilski Chudotvorets - 2010
Plovdiv, 4003
Bulgaria
Ambulatory for Individual Primary Medical Care - Dr. Pavlina Petrova - Poli ET
Sofia, 1142
Bulgaria
Medical Center Hera EOOD
Sofia, 1510
Bulgaria
Medical Center Diana Med 2001
Yambol, 8600
Bulgaria
Vancouver Infectious Diseases Centre
Vancouver, British Columbia V6Z 2E9
Canada
Clinical Research of Ontario
Scarborough Village, Ontario M1S 4T7
Canada
Community Care Building
Winchester, Ontario K0C 2K0
Canada
Dundas Manor Nursing Home
Winchester, Ontario K0C 2K0
Canada
Winchester District Memorial Hospital
Winchester, Ontario K0C 2K0
Canada
The People's Hospital of Chizhou
Chizhou, Anhui 247000
China
Peking University People's Hospital
Beijing, Beijing Municipality 100044
China
Zhongshan Hospital Fudan University (Xiamen Branch)
Xiamen, Fujian 361004
China
Zhongshan Hospital Xiamen University
Xiamen, Fujian 361004
China
ZhuJiang Hospital of Southern Medical University
Guangzhou, Guangdong 510280
China
The Second Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi 530007
China
The Third Hospital of Changsha
Changsha, Hunan 410015
China
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi 330038
China
The First Hospital of Jilin University
Changchun, Jilin 130021
China
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality 200040
China
Shanghai Children's Medical Center
Shanghai, Shanghai Municipality 200120
China
Shanghai Minhang District Central Hospital
Shanghai, Shanghai Municipality 201199
China
First Affiliated Hospital of Shanxi Medical University
Taiyuan, Shanxi 030001
China
Tianjin First Central Hospital
Tianjin, Tianjin Municipality 300384
China
The First People's Hospital of Yunnan Province
Kunming, Yunnan 650032
China
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang 310016
China
Beijing Ditan Hospital Capital Medical
Beijing, 100015
China
Doktor Brno
Brno, Brno-město 602 00
Czechia
Lékařský dům v Mezibranské
Prague, Praha 1 110 00
Czechia
Ordinace Hradebni s.r.o.
České Budějovice, South Bohemian Region 370 01
Czechia
Zdravi-fit
Protivín, South Bohemian Region 398 11
Czechia
ORL MUDr Pavel Navratil
Olomouc, 779 00
Czechia
Rigshospitalet
Copenhagen, Capital Region 2100
Denmark
Nordsjællands Hospital - Hillerød
Hilleroed, Capital Region 3400
Denmark
Regionshospitalet Gødstrup
Herning, Central Jutland 7400
Denmark
Roskilde Sygehus
Roskilde, Region Sjælland 4000
Denmark
Aalborg Universitetshospital, Syd
Gistrup, 9260
Denmark
FVR, Oulun rokotetutkimusklinikka
Oulu, North Ostrobothnia 90220
Finland
FVR, Tampereen rokotetutkimusklinikka
Tampere, Pirkanmaa 33100
Finland
FVR, Etelä-Helsingin rokotetutkimusklinikka
Helsinki, Uusimaa 00100
Finland
MeVac - Meilahti Vaccine Research Center
Helsinki, Uusimaa 00290
Finland
LMU Klinikum München
Munich, Bavaria 80336
Germany
Praxisgemeinschaft Heimeranplatz
Munich, Bavaria 80339
Germany
IKF Pneumologie Frankfurt, Clinical Research Center, Departments: Pulmonology, Endocrinology, Cardio
Frankfurt am Main, Hesse 60596
Germany
Studien Rahman & Detho
Obertshausen, Hesse 63179
Germany
Praxis am Ebertplatz
Cologne, North Rhine-Westphalia 50668
Germany
Universitätsklinikum Augsburg
Augsburg, 86156
Germany
Novopraxis Berlin GbR
Berlin, 10117
Germany
zibp Zentrum für lnfektiologie Berlin Prenzlauer Berg GmbH
Berlin, 10439
Germany
Charité - Universitätsmedizin Berlin
Berlin, 13353
Germany
Universitätsklinik Freiburg
Freiburg im Breisgau, 79106
Germany
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, 20246
Germany
University of Rostock
Rostock, 18057
Germany
Kamezawa Clinic
Kasugai, Aichi-ken 486-0817
Japan
International University of Health and Welfare Narita Hospital
Narita, Chiba 286-8520
Japan
Tashiro Endocrinology Clinic
Fukuoka, Fukuoka 814-0153
Japan
Medical Corporation Kouhoukai Takagi Hospital
Okawa-shi, Fukuoka 831-0016
Japan
Nishioka Hospital
Sapporo, Hokkaido 062-0034
Japan
Terada Clinic Respiratory Medicine & General Practice
Himeji, Hyōgo 670-0849
Japan
Koga General Hospital
Koga-shi, Ibaraki 306-0041
Japan
Tsuchiura Beryl Clinic
Tsuchiura, Ibaraki 300-0062
Japan
Shonan Fujisawa Tokushukai Hospital
Fujisawa, Kanagawa 251-0041
Japan
Shonan Kamakura General Hospital
Kamakura, Kanagawa 247-8533
Japan
Rakuwakai Otowa Hospital
Kyoto, Kyoto 607-8062
Japan
National Hospital Organization Okinawa Hospital
Ginowan, Okinawa 901-2214
Japan
Fukuwa Clinic
Chuo-ku, Tokyo 104-0031
Japan
Musashino Emergency Hospital
Kodaira-shi, Tokyo 187-0031
Japan
Swing Nozaki Clinic
Musashino-shi, Tokyo 180-0022
Japan
Yoshijima Hospital
Hiroshima, 730-0822
Japan
Asociación Mexicana para la Investigación Clínica A.C.
Pachuca, Hidalgo 42082
Mexico
JM Research SC
Cuernavaca, Morelos 62290
Mexico
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
Monterrey, Nuevo León 64460
Mexico
Eukarya Pharmasite S.C.
Monterrey, Nuevo León 64718
Mexico
Clinstile, S.A. de C.V.
Mexico City, 06700
Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico City, 14080
Mexico
Arké SMO S.A de C.V
Veracruz, 91900
Mexico
IRS - Medicinska cinnost s.r.o., Vseobecna ambulancia pre dospelych
Kosice-Juh, Košice Region 040 01
Slovakia
Artromac n.o.
Košice, Košice Region 040 11
Slovakia
ML MED, s.r.o., Vseobecna ambulancia pre dospelych
Moldava nad Bodvou, Košice Region 045 01
Slovakia
Plucna ambulancia Hrebenar, s.r.o., Pneumologicko-ftizeologicka ambulancia
Spišská Nová Ves, Košice Region 052 01
Slovakia
PULMO, s.r.o., Pneumologicko-ftizeologicka ambulancia
Prešov, Presov 080 01
Slovakia
SALUBER SK s.r.o., Vseobecna ambulancia pre dospelych
Nové Mesto nad Váhom, Trenčín Region 915 01
Slovakia
MUDr. Viliam Cibik, PhD., s.r.o.
Pruské, Trenčín Region 018 52
Slovakia
AMB4YOU s.r.o.
Hlohovec, Trnava Region 920 01
Slovakia
VL.AK s.r.o. Vseobecna ambulancia pre dospelych
Trnava, Trnava Region 917 01
Slovakia
Newtown Clinical Research
Johannesburg, Gauteng 2113
South Africa
Global Clinical Trials
Pretoria, Gauteng 0157
South Africa
Jongaie Research
Pretoria West, Gauteng 0183
South Africa
Sandton Medical Research Centre
Sandton, Gauteng 2196
South Africa
Synapta Clinical Research Centre
Durban, KwaZulu-Natal 4001
South Africa
Private Practice - Dr. Peter Sebastian
Silverglen Durban, KwaZulu-Natal 4092
South Africa
Langeberg Clinical Trials
Cape Town, Western Cape 7570
South Africa
Paarl Research Centre
Paarl, Western Cape 7646
South Africa
TREAD Research
Parow, Western Cape 7500
South Africa
Incheon Medical Center
Donggu, Incheon-gwangyeoksi [incheon] 22532
South Korea
Gachon University Gil Medical Center
Namdong-gu, Incheon-gwangyeoksi [incheon] 21565
South Korea
Wonju Severance Christian Hospital
Wŏnju, Kang-won-do 26426
South Korea
Chonnam National University Hospital
Gwangju, Kwangju-kwangyǒkshi 61469
South Korea
Korea University Ansan Hospital
Ansan-si, Kyǒnggi-do 15355
South Korea
Ajou University Hospital
Suwon, Kyǒnggi-do 16499
South Korea
Chung-Ang University Hospital
Dongjak-gu, Seoul-teukbyeolsi [seoul] 06973
South Korea
Gangnam Severance Hospital, Yonsei University Health System
Gangnam-gu, Seoul-teukbyeolsi [seoul] 06273
South Korea
Korea University Anam Hospital
Seoul, Seoul-teukbyeolsi [seoul] 02841
South Korea
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
Seoul, Seoul-teukbyeolsi [seoul] 03312
South Korea
Hallym University Kangnam Sacred Heart Hospital
Seoul, Seoul-teukbyeolsi [seoul] 07441
South Korea
Korea University Guro Hospital
Seoul, Seoul-teukbyeolsi [seoul] 08308
South Korea
Keimyung University Dongsan Hospital
Daegu, Taegu-kwangyǒkshi 42601
South Korea
CHUAC-Complejo Hospitalario Universitario A Coruña
A Coruña, A Coruña [LA Coruña] 15006
Spain
Hospital Vithas Xanit Internacional
Benalmádena, Andalusia 29631
Spain
Hospital Universitario Reina Sofia
Córdoba, Andalusia 14004
Spain
Hospital Germans Trias i Pujol
Badalona, Barcelona [barcelona] 08916
Spain
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [barcelona] 08035
Spain
Hospital Universitario La Paz
Madrid, Madrid, Comunidad de 28046
Spain
CHUVI- Hospital Alvaro Cunqueiro
Vigo, Pontevedra [pontevedra] 36312
Spain
Hospital General Universitario Dr. Balmis
Alicante, 03010
Spain
Hospital Universitario Infanta Leonor
Madrid, 28031
Spain
Hospital Universitario Virgen de Valme
Seville, 41014
Spain
Far Eastern Memorial Hospital
New Taipei City, NEW Taipei 220
Taiwan
Taichung Veterans General Hospital
Taichung, 407
Taiwan
Taipei Veterans General Hospital
Taipei, 11217
Taiwan
Tri-Service General Hospital
Taipei, 114
Taiwan
Chang Gung Medical Foundation-Linkou Branch
Taoyuan, 333
Taiwan
Acibadem Universitesi Atakent Hastanesi
Istanbul, İ̇stanbul 34303
Turkey (Türkiye)
Ankara University Ibni Sina Hospital
Ankara, 06230
Turkey (Türkiye)
Hacettepe Universite Hastaneleri
Ankara, 06230
Turkey (Türkiye)
Ankara Bilkent Şehir Hastanesi
Ankara, 06800
Turkey (Türkiye)
Gaziantep Universitesi Sahinbey Arastirma ve Uygulama Hastanesi
Gaziantep, 27310
Turkey (Türkiye)
Kocaeli Üniversitesi
Kocaeli, 41380
Turkey (Türkiye)
Sakarya Training and Research Hospital
Sakarya, 54100
Turkey (Türkiye)
Karadeniz Technical University
Trabzon, 61080
Turkey (Türkiye)