A Study to Learn About the Study Medicine Ibuzatrelvir in Adults With COVID-19 Who Are Severely Immunocompromised
Start Date
7/14/2025
Completion Date
2/25/2028
Summary
This is a Phase 3, randomized, actively controlled, double-blinded, double-dummy, superiority study to evaluate the efficacy and safety of ibuzatrelvir alone and in combination with remdesivir IV compared to remdesivir IV alone for the treatment of symptomatic COVID-19 in severely immunocompromised adult participants who are non-hospitalized or are hospitalized for observation or study intervention administration but do not require supplemental oxygen for COVID-19.
Detailed Description
The purpose of this clinical trial is to learn about a study medicine called Ibuzatrelvir for the possible treatment of COVID-19 in immunocompromised patients. Immunocompromised patients with COVID-19 have more difficulty fighting infections and are at risk for persistent infections and progression to severe illness. This patient population may benefit from extended antiviral treatment durations, or a combination of antiviral therapies. This study will evaluate the efficacy and safety of ibuzatrelvir with and without remdesivir compared with remdesivir alone for the treatment of symptomatic COVID-19 in adult participants who are severely immunocompromised. The study is seeking adult male and female participants who: * Have a confirmed COVID-19 infection * Are severely immunocompromised due to blood cancers, organ transplant, certain medications or therapies * Have experienced the onset of signs or symptoms of COVID-19 within the past 5 days and are currently experiencing at least one of them. All of the participants in this study will receive active treatment for COVID-19, and will be randomized to one of three treatment arms. One-third will received remdesivir, one-third will receive ibuzatrelvir, and one third will receive both remdesivir and ibuzatrelvir. Ibuzatrelvir will be taken by mouth twice daily, and remdesivir is given as an IV infusion daily. Placebos that look like the study medicines but do not have any medication will be given to make the 3 treatment arms appear to be the same. The study will compare the experiences of people receiving ibuzatrelvir with and without remdesivir to those of the people who only received remdesivir for COVID-19. This will help decide if ibuzatrelvir is safe and effective. Participants will attend about 10 study visits over 24 weeks. During this time, they will have: * visits at the study clinic * blood work * swabs of the nose that are collected in the clinic and also by participants at home * questionnaires
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
ibuzatrelvir
remdesivir
placebo for ibuzatrelvir
placebo for remdesivir
Conditions
Locations
Hope Clinical Research, Inc.
Canoga Park, California 91303
United States
Amicis Research Center - Granada Hills
Granada Hills, California 91344
United States
Jacobs Medical Center at UC San Diego Health
La Jolla, California 92037
United States
UC Davis CTSC Clinical Research Center
Sacramento, California 95817
United States
University of California Davis Health
Sacramento, California 95817
United States
UC San Diego Medical Center - Hillcrest
San Diego, California 92103
United States
University of California San Diego Health
San Diego, California 92103
United States
UCHealth Anschutz Inpatient Pavilion - Anschutz Medical Campus
Aurora, Colorado 80045
United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado 80045
United States
University of Colorado Clinical and Translational Research Center
Aurora, Colorado 80045
United States
University of Colorado Hospital
Aurora, Colorado 80045
United States
Georgetown University Medical Center
Washington D.C., District of Columbia 20007
United States
BRP- Hialeah Hospital
Hialeah, Florida 33013
United States
D&H Cancer Research Center LLC
Margate, Florida 33063
United States
Kendall South Medical Center
Miami, Florida 33185
United States
Velocity Clinical Research, Savannah
Savannah, Georgia 31406
United States
Humphreys Diabetes Center
Boise, Idaho 83702
United States
St. Luke's Idaho Elks Children's Pavilion
Boise, Idaho 83712
United States
Northwestern Memorial Hospital
Chicago, Illinois 60611
United States
Northwestern University Feinberg School of Medicine
Chicago, Illinois 60611
United States
Johns Hopkins Hospital
Baltimore, Maryland 21287
United States
Jadestone Clinical Research
Silver Spring, Maryland 20904
United States
Brigham and Women's Hospital
Boston, Massachusetts 02115
United States
Clinical Trials Center
Boston, Massachusetts 02115
United States
Clinical Trials Hub
Boston, Massachusetts 02115
United States
University of Massachusetts Chan Medical School
Worcester, Massachusetts 01655
United States
University of Michigan
Ann Arbor, Michigan 48109
United States
Henry Ford Hospital
Detroit, Michigan 48202
United States
Profound Research LLC
Farmington Hills, Michigan 48334
United States
Holy Name Medical Center
Teaneck, New Jersey 07666
United States
Duke Vaccine and Trials Unit
Durham, North Carolina 27703
United States
Duke Vaccine and Trials Unit
Durham, North Carolina 27705
United States
Duke University - Main Hospital and Clinics
Durham, North Carolina 27710
United States
University of Cincinnati Medical Center
Cincinnati, Ohio 45219
United States
University of Cincinnati College of Medicine (UC Holmes)
Cincinnati, Ohio 45267
United States
TRC
Pittsburgh, Pennsylvania 15213
United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania 15213
United States
UPMC Division of Infectious Disease Clinic
Pittsburgh, Pennsylvania 15213
United States
UPMC Presbyterian IDS
Pittsburgh, Pennsylvania 15213
United States
UPMC Presbyterian Shadyside
Pittsburgh, Pennsylvania 15213
United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania 15232
United States
UPMC Shadyside IDS
Pittsburgh, Pennsylvania 15232
United States
UPMC Shadyside
Pittsburgh, Pennsylvania 15232
United States
Medical University of South Carolina Infectious Disease Clinic
Charleston, South Carolina 29425
United States
Medical University of South Carolina Investigational Drug Services (IDS)
Charleston, South Carolina 29425
United States
Medical University of South Carolina Investigational Drug Services Pharmacy
Charleston, South Carolina 29425
United States
Medical University of South Carolina Research Nexus Clinic
Charleston, South Carolina 29425
United States
Medical University of South Carolina Translational Research Nexus Clinic and Laboratory
Charleston, South Carolina 29425
United States
Medical University of South Carolina
Charleston, South Carolina 29425
United States
West Tennessee Research Institute
Jackson, Tennessee 38305
United States
Zenos Clinical Research
Dallas, Texas 75230
United States
Baylor Scott & White Health - Center for Advanced Heart and Lung Disease
Dallas, Texas 75246
United States
Baylor Scott & White Research Institute - Clinical Trials Office
Dallas, Texas 75246
United States
Baylor University Medical Center
Dallas, Texas 75246
United States
Houston Methodist Hospital
Houston, Texas 77030
United States
Memorial Hermann Hospital
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
Seattle Rheumatology Associates
Seattle, Washington 98104
United States
Swedish Ambulatory Infusion Center- First Hill
Seattle, Washington 98104
United States
Swedish Cancer Institute Treatment Center
Seattle, Washington 98104
United States
Swedish Medical Center- Innovative Therapeutics & Research Unit
Seattle, Washington 98104
United States
Swedish Organ Transplant and Liver Center
Seattle, Washington 98104
United States
Fred Hutchinson Cancer Center
Seattle, Washington 98109
United States
Fred Hutchinson South Lake Union Clinic
Seattle, Washington 98109
United States
Swedish Medical Center - First Hill Campus
Seattle, Washington 98122
United States
University of Washington Medical Center
Seattle, Washington 98195
United States
Hospital Italiano de La Plata
La Plata, Buenos Aires B1900XI
Argentina
Hospital Italiano de Buenos Aires
ABB, Buenos Aires F.D. C1199ABB
Argentina
Instituto Médico Río Cuarto
Río Cuarto, Córdoba Province X5800AEV
Argentina
Sanatorio Sagrado Corazón
Buenos Aires, 1039
Argentina
UZ Brussel
Brussels, Brussels Capital 1090
Belgium
Université Libre de Bruxelles - Hôpital Erasme
Brussels, Bruxelles-capitale, Région de 1070
Belgium
AZ Sint-Jan Brugge-Oostende AV
Bruges, West-vlaanderen 8000
Belgium
Jules Bordet Institute
Anderlecht, 1070
Belgium
School of Medicine Federal University of Minas Gerais
Belo Horizonte, Minas Gerais 30130-100
Brazil
Hospital Nossa Senhora das Graças
Curitiba, Paraná 80810-040
Brazil
Centro Médico São Francisco
Curitiba, Paraná 80810-050
Brazil
Hospital de Clinicas de Porto Alegre
Bairro Santa Cecília, Rio Grande do Sul 90630-165
Brazil
Hospital e Maternidade Celso Pierro
Campinas, São Paulo 13060-803
Brazil
CECIP - Centro de Estudos do Interior Paulista
Jaú, São Paulo 17201130
Brazil
Instituto Nacional de Infectologia Evandro Chagas
Rio de Janeiro, 21040-360
Brazil
Icesp - Instituto Do Câncer Do Estado de São Paulo
São Paulo, 01246-000
Brazil
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
São Paulo, 05652-900
Brazil
Rigshospitalet
Copenhagen, Capital Region 2100
Denmark
Aarhus Universitetshospital, Skejby
Aarhus, Central Jutland 8200
Denmark
Odense Universitetshospital
Odense, Region Syddanmark 5000
Denmark
Aalborg Universitetshospital, Syd
Gistrup, 9260
Denmark
Hopital Claude Huriez - CHU de Lille
Lille, NORD 59037
France
Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital François Mitterrand
Dijon, 21000
France
Hôpital Saint Antoine
Paris, 75012
France
Hôpital Bichat - Claude-Bernard
Paris, 75018
France
Hôpital Saint-Louis
Paris, Île-de-France Region 75010
France
TUM Klinikum
München, Bavaria 81675
Germany
Universitaetsklinikum Koeln
Cologne, North Rhine-Westphalia 50937
Germany
UKE Hamburg
Hamburg, 20246
Germany
University General Hospital of Alexandroupoli
Alexandroupoli, Anatolikí Makedonía KAI Thráki 681 00
Greece
Evangelismos General Hospital of Athens
Athens, Attikí 106 76
Greece
Alexandra General Hospital of Athens
Athens, Attikí 115 28
Greece
General Hospital of Athens "Laiko"
Athens, Attikí 11527
Greece
University General Hospital of Heraklion
Irakleio, 715 00
Greece
Ippokrateio General Hospital of Thessaloniki
Thessaloniki, 546 42
Greece
Fujita Health University Hospital
Toyoake, Aichi-ken 470-1192
Japan
International University of Health and Welfare Narita Hospital
Narita, Chiba 286-8520
Japan
Aso Iizuka Hospital
Iizuka, Fukuoka 820-8505
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
Tachikawa Hospital
Tachikawa, Tokyo 190-8531
Japan
National Hospital Organization Kyushu Medical Center
Fukuoka, 810-8563
Japan
Nagasaki University Hospital
Nagasaki, 852-8501
Japan
Saga University Hospital
Saga, 849-8501
Japan
Fundación Santos y de la Garza Evia I.B.P
San Pedro Garza García, Nuevo León 66278
Mexico
FAICIC S. de R.L. de C.V.
Veracruz, Veracruz Ignacio de LA Llave 91900
Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico City, 14080
Mexico
Radboudumc
Nijmegen, 6525 GA
Netherlands
Erasmus MC
Rotterdam, 3015GD
Netherlands
BRCR Global Puerto Rico
San Juan, United States of America 00907-1509
Puerto Rico
BRCR Medical Center - Ponce
Ponce, 00717
Puerto Rico
Canas Medical Center
Ponce, 00728
Puerto Rico
Fakultna nemocnica s poliklinikou F.D.Roosevelta Banska Bystrica
Banská Bystrica, Banská Bystrica Region 974 01
Slovakia
Narodny ustav detskych chorob
Bratislava, Bratislava Region 833 40
Slovakia
Fakultna nemocnica Trnava
Trnava, Trnava Region 917 02
Slovakia
Narodny onkologicky ustav
Bratislava, 833 10
Slovakia
Nemocnica s poliklinikou Stefana Kukuru Michalovce, a.s.
Michalovce, 07101
Slovakia
Gachon University Gil Medical Center
Namdong-gu, Incheon-gwangyeoksi [incheon] 21565
South Korea
Chonnam National University Hospital
Gwangju, Kwangju-kwangyǒkshi 61469
South Korea
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
Seoul, Seoul-teukbyeolsi [seoul] 03312
South Korea
Asan Medical Center
Seoul, Seoul-teukbyeolsi [seoul] 05505
South Korea
CHUAC-Complejo Hospitalario Universitario A Coruña
A Coruña, A Coruña [LA Coruña] 15006
Spain
Hospital Universitario Reina Sofia
Córdoba, Andalusia 14004
Spain
Hospital Germans Trias i Pujol
Badalona, Barcelona [barcelona] 08916
Spain
Parc de Salut Mar - Hospital del Mar
Barcelona, Barcelona [barcelona] 08003
Spain
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [barcelona] 08035
Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalunya [cataluña] 08041
Spain
Hospital Universitario La Paz
Madrid, Madrid, Comunidad de 28046
Spain
CHUVI- Hospital Alvaro Cunqueiro
Vigo, Pontevedra [pontevedra] 36212
Spain
Hospital General Universitario Dr. Balmis
Alicante, 03010
Spain
Hospital Universitario Virgen de Valme
Seville, 41014
Spain
Skånes Universitetssjukhus Malmö
Malmö, Skåne LÄN [se-12] 205 02
Sweden
Karolinska Universitetssjukhuset Huddinge
Huddinge, 141 86
Sweden
Far Eastern Memorial Hospital
New Taipei City, NEW Taipei 220
Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807
Taiwan
Taichung Veterans General Hospital
Taichung, 407
Taiwan
Taipei Veterans General Hospital
Taipei, 11217
Taiwan
Acibadem Universitesi Atakent Hastanesi
Istanbul, İ̇stanbul 34303
Turkey (Türkiye)
Hacettepe Universite Hastaneleri
Ankara, 06230
Turkey (Türkiye)
Ibni Sina Hospital
Ankara, 06230
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)