RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: Pfizer • ClinicalTrials.gov ID: NCT07013474

Registry updated: 2026-10-14

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Description

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 at baseline with mild-to-moderate COVID-19.

Interventions

ibuzatrelvir (Drug)
tablet
remdesivir (Drug)
injection, for intravenous use
placebo for ibuzatrelvir (Drug)
tablet
placebo for remdesivir (Drug)
injection, for intravenous use

Eligibility criteria

Inclusion Criteria: 1. 18 years of age or older at screening who are non-hospitalized or hospitalized with mild to moderate COVID-19 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 or critical COVID-19, or current need for supplemental oxygen. 2. Receiving dialysis or have current kidney failure (ie, eGFR consistently \<15 mL/min) 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.

Conditions

COVID-19 Infection

Locations

Hope Clinical Research, Inc. — Canoga Park, California, United States
Amicis Research Center - Granada Hills — Granada Hills, California, United States
Jacobs Medical Center at UC San Diego Health — La Jolla, California, United States
UC Davis CTSC Clinical Research Center — Sacramento, California, United States
University of California Davis Health — Sacramento, California, United States
UC San Diego Medical Center - Hillcrest — San Diego, California, United States
University of California San Diego Health — San Diego, California, United States
UCHealth Anschutz Inpatient Pavilion - Anschutz Medical Campus — Aurora, Colorado, United States
University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States
University of Colorado Clinical and Translational Research Center — Aurora, Colorado, United States
University of Colorado Hospital — Aurora, Colorado, United States
Georgetown University Medical Center — Washington D.C., District of Columbia, United States
BRP- Hialeah Hospital — Hialeah, Florida, United States
D&H Cancer Research Center LLC — Margate, Florida, United States
Kendall South Medical Center — Miami, Florida, United States
Velocity Clinical Research, Savannah — Savannah, Georgia, United States
Humphreys Diabetes Center — Boise, Idaho, United States
St. Luke's Idaho Elks Children's Pavilion — Boise, Idaho, United States
Northwestern Memorial Hospital — Chicago, Illinois, United States
Northwestern University Feinberg School of Medicine — Chicago, Illinois, United States
Johns Hopkins Hospital — Baltimore, Maryland, United States
Jadestone Clinical Research — Silver Spring, Maryland, United States
Brigham and Women's Hospital — Boston, Massachusetts, United States
Clinical Trials Center — Boston, Massachusetts, United States
Clinical Trials Hub — Boston, Massachusetts, United States
University of Massachusetts Chan Medical School — Worcester, Massachusetts, United States
University of Michigan — Ann Arbor, Michigan, United States
Henry Ford Hospital — Detroit, Michigan, United States
Holy Name Medical Center — Teaneck, New Jersey, United States
NYU Langone Health — New York, New York, United States
Duke Vaccine and Trials Unit — Durham, North Carolina, United States
Duke Vaccine and Trials Unit — Durham, North Carolina, United States
Duke University - Main Hospital and Clinics — Durham, North Carolina, United States
University of Cincinnati Medical Center — Cincinnati, Ohio, United States
University of Cincinnati College of Medicine (UC Holmes) — Cincinnati, Ohio, United States
TRC — Pittsburgh, Pennsylvania, United States
University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
UPMC Division of Infectious Disease Clinic — Pittsburgh, Pennsylvania, United States
UPMC Presbyterian IDS — Pittsburgh, Pennsylvania, United States
UPMC Presbyterian Shadyside — Pittsburgh, Pennsylvania, United States
UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania, United States
UPMC Shadyside IDS — Pittsburgh, Pennsylvania, United States
UPMC Shadyside — Pittsburgh, Pennsylvania, United States
Medical University of South Carolina Infectious Disease Clinic — Charleston, South Carolina, United States
Medical University of South Carolina Investigational Drug Services (IDS) — Charleston, South Carolina, United States
Medical University of South Carolina Investigational Drug Services Pharmacy — Charleston, South Carolina, United States
Medical University of South Carolina Research Nexus Clinic — Charleston, South Carolina, United States
Medical University of South Carolina Translational Research Nexus Clinic and Laboratory — Charleston, South Carolina, United States
Medical University of South Carolina — Charleston, South Carolina, United States
West Tennessee Research Institute — Jackson, Tennessee, United States
Zenos Clinical Research — Dallas, Texas, United States
Baylor Scott & White Health - Center for Advanced Heart and Lung Disease — Dallas, Texas, United States
Baylor Scott & White Research Institute - Clinical Trials Office — Dallas, Texas, United States
Baylor University Medical Center — Dallas, Texas, United States
Cockrell Center for Advanced Therapeutics — Houston, Texas, United States
Houston Methodist - Transplant Center — Houston, Texas, United States
Houston Methodist Hospital — Houston, Texas, United States
Memorial Hermann Hospital — Houston, Texas, United States
Scurlock CCAT clinic — Houston, Texas, United States
The University of Texas Health Science Center at Houston — Houston, Texas, United States
UT Physicians — Houston, Texas, United States
Seattle Rheumatology Associates — Seattle, Washington, United States
Swedish Ambulatory Infusion Center- First Hill — Seattle, Washington, United States
Swedish Cancer Institute Treatment Center — Seattle, Washington, United States
Swedish Medical Center- Innovative Therapeutics & Research Unit — Seattle, Washington, United States
Swedish Organ Transplant and Liver Center — Seattle, Washington, United States
Fred Hutchinson Cancer Center — Seattle, Washington, United States
Fred Hutchinson South Lake Union Clinic — Seattle, Washington, United States
Swedish Medical Center - First Hill Campus — Seattle, Washington, United States
University of Washington Medical Center — Seattle, Washington, United States
Hospital Italiano de La Plata — La Plata, Buenos Aires, Argentina
Hospital Italiano de Buenos Aires — ABB, Buenos Aires F.D., Argentina
Instituto Médico Río Cuarto — Río Cuarto, Córdoba Province, Argentina
Sanatorio Sagrado Corazón — Buenos Aires, Argentina
UZ Brussel — Brussels, Brussels Capital, Belgium
Université Libre de Bruxelles - Hôpital Erasme — Brussels, Bruxelles-capitale, Région de, Belgium
AZ Sint-Jan Brugge-Oostende AV — Bruges, West-vlaanderen, Belgium
Jules Bordet Institute — Anderlecht, Belgium
School of Medicine Federal University of Minas Gerais — Belo Horizonte, Minas Gerais, Brazil
Hospital Nossa Senhora das Graças — Curitiba, Paraná, Brazil
Centro Médico São Francisco — Curitiba, Paraná, Brazil
Hospital de Clinicas de Porto Alegre — Bairro Santa Cecília, 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
Instituto Nacional de Infectologia Evandro Chagas — Rio de Janeiro, Brazil
Icesp - Instituto Do Câncer Do Estado de São Paulo — São Paulo, Brazil
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein — São Paulo, Brazil
Rigshospitalet — Copenhagen, Capital Region, Denmark
Aarhus Universitetshospital, Skejby — Aarhus, Central Jutland, Denmark
Odense Universitetshospital — Odense, Region Syddanmark, Denmark
Aalborg Universitetshospital, Syd — Gistrup, Denmark
Hopital Claude Huriez - CHU de Lille — Lille, NORD, France
Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital François Mitterrand — Dijon, France
Hôpital Saint Antoine — Paris, France
Hôpital Bichat - Claude-Bernard — Paris, France
Hôpital Saint-Louis — Paris, Île-de-France Region, France
TUM Klinikum — München, Bavaria, Germany
Universitaetsklinikum Koeln — Cologne, North Rhine-Westphalia, Germany
UKE Hamburg — Hamburg, Germany
Universitaetsmedizin Rostock — Rostock, Germany
Klinikum Mutterhaus der Borromaerinnen gGmbH — Trier, Germany
Kliniken Villingen-Schwenningen — Villingen-Schwenningen, Germany
HELIOS Klinikum Wuppertal — Wuppertal, Germany
University General Hospital of Alexandroupoli — Alexandroupoli, Anatolikí Makedonía KAI Thráki, Greece
Evangelismos General Hospital of Athens — Athens, Attikí, Greece
Alexandra General Hospital of Athens — Athens, Attikí, Greece
General Hospital of Athens "Laiko" — Athens, Attikí, Greece
University General Hospital "ATTIKON" - General Hospital of West Attica "H AGIA VARVARA" — Chaïdári, Greece
University General Hospital of Heraklion — Irakleio, Greece
Ippokrateio General Hospital of Thessaloniki — Thessaloniki, Greece
Fujita Health University Hospital — Toyoake, Aichi-ken, Japan
International University of Health and Welfare Narita Hospital — Narita, Chiba, Japan
Aso Iizuka Hospital — Iizuka, Fukuoka, Japan
Rinku General Medical Center — Izumisano, Osaka, Japan
Tokyo Medical University Hachioji Medical Center — Hachiōji, Tokyo, Japan
National Center for Global Health and Medicine — Shinjuku, Tokyo, Japan
Tachikawa Hospital — Tachikawa, Tokyo, Japan
National Hospital Organization Kyushu Medical Center — Fukuoka, Japan
Nagasaki University Hospital — Nagasaki, Japan
Saga University Hospital — Saga, Japan
Fundación Santos y de la Garza Evia I.B.P — San Pedro Garza García, Nuevo León, Mexico
FAICIC S. de R.L. de C.V. — Veracruz, Veracruz Ignacio de LA Llave, Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran — Mexico City, Mexico
Radboudumc — Nijmegen, Netherlands
Erasmus MC — Rotterdam, Netherlands
BRCR Global Puerto Rico — Ponce, Puerto Rico
BRCR Global Puerto Rico — San Juan, Puerto Rico
Fakultna nemocnica s poliklinikou F.D.Roosevelta Banska Bystrica — Banská Bystrica, Banská Bystrica Region, Slovakia
Narodny ustav detskych chorob — Bratislava, Bratislava Region, Slovakia
Fakultna nemocnica Trnava — Trnava, Trnava Region, Slovakia
Narodny onkologicky ustav — Bratislava, Slovakia
Nemocnica s poliklinikou Stefana Kukuru Michalovce, a.s. — Michalovce, Slovakia
Gachon University Gil Medical Center — Namdong-gu, Incheon-gwangyeoksi [incheon], South Korea
Chonnam National University Hospital — Gwangju, Kwangju-kwangyǒkshi, South Korea
The Catholic University of Korea, Eunpyeong St. Mary's Hospital — Seoul, Seoul-teukbyeolsi [seoul], South Korea
Asan Medical Center — Seoul, Seoul-teukbyeolsi [seoul], South Korea
CHUAC-Complejo Hospitalario Universitario A Coruña — A Coruña, A Coruña [LA Coruña], Spain
Hospital Universitario Reina Sofia — Córdoba, Andalusia, Spain
Hospital Germans Trias i Pujol — Badalona, Barcelona [barcelona], Spain
Parc de Salut Mar - Hospital del Mar — Barcelona, Barcelona [barcelona], Spain
Hospital Universitari Vall d'Hebron — Barcelona, Barcelona [barcelona], Spain
Hospital de la Santa Creu i Sant Pau — Barcelona, Catalunya [cataluña], 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 Virgen de Valme — Seville, Spain
Skånes Universitetssjukhus Malmö — Malmö, Skåne LÄN [se-12], Sweden
Karolinska Universitetssjukhuset Huddinge — Huddinge, Sweden
Far Eastern Memorial Hospital — New Taipei City, NEW Taipei, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital — Kaohsiung City, Taiwan
Taichung Veterans General Hospital — Taichung, Taiwan
Taipei Veterans General Hospital — Taipei, Taiwan
Acibadem Universitesi Atakent Hastanesi — Istanbul, İ̇stanbul, Turkey (Türkiye)
Hacettepe Universite Hastaneleri — Ankara, Turkey (Türkiye)
Ibni Sina Hospital — 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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