Back to Trials
NCT07013474PHASE3Recruiting

A Study to Learn About the Study Medicine Ibuzatrelvir in Adults With COVID-19 Who Are Severely Immunocompromised

Pfizer

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

Inclusion Criteria: 1. 18 years of age or older at screening who are non-hospitalized or hospitalized for observation or with the intent of administering the study intervention. 2. Confirmed SARS-CoV-2 infection as determined by RAT (or other locally approved test) collected within 2 days prior to randomization. Initial onset of symptoms attributable to COVID-19 within 5 days prior to the day of randomization and at least 1 of the specified symptoms attributable to COVID-19 present on the day of randomization. 3. Severely immunocompromised due to: * Solid organ or islet cell transplant recipient who is receiving immunosuppressive therapy; * Active hematologic malignancy (eg, chronic lymphocytic leukemia, non-Hodgkin lymphoma, multiple myeloma, acute leukemia); * Receipt of CAR-T-cell therapy or HCT either within 2 years of transplantation or who are receiving immunosuppressive therapy; * Currently receiving or recently received B-cell depleting therapies (eg, rituximab), where the immunosuppressive effect is still ongoing. Exclusion Criteria: 1. Severe COVID-19, or current need for supplemental oxygen for treatment of COVID-19. 2. Receiving dialysis or have current kidney failure (ie, eGFR consistently \<15 mL/min/1.73 m2) 3. Active liver disease 4. History of hypersensitivity or other contraindication to any of the components of the study interventions, as determined by the investigator 5. Suspected or confirmed concurrent active systemic infection other than COVID-19 that may interfere with the evaluation of response to the study intervention. 6. Life expectancy less than 30 days at study entry due to an underlying condition, in the judgement of the investigator. 7. Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study. 8. Has received any other antiviral for the treatment of the current COVID-19 infection 9. Current use of any prohibited concomitant medication(s) or unwillingness or inability to use a required concomitant medication(s). 10. Current or previous administration of an investigational product (drug or vaccine) within 30 days (or as determined by local requirement) or 5 half lives preceding the first dose of study intervention used in this study (whichever is longer). Authorized or products with conditional approval are not considered investigational. 11. Prior participation in this trial or any clinical trial of ibuzatrelvir. 12. Females who are pregnant, breastfeeding, or who are planning to become pregnant within the timeframe of the study. 13. Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.

Interventions

DRUG

ibuzatrelvir

DRUG

remdesivir

DRUG

placebo for ibuzatrelvir

DRUG

placebo for remdesivir

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

COVID-19 Infection

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)