A Study to Learn About the Study Medicine Ibuzatrelvir in Adults With COVID-19 Who Are Severely Immunocompromised
NCT ID: NCT07013474
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
300 participants
INTERVENTIONAL
2025-07-14
2027-05-06
Brief Summary
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Detailed Description
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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
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Ibuzatrelvir
Participants will receive ibuzatrelvir orally twice a day + IV placebo for remdesivir
ibuzatrelvir
tablet
placebo for remdesivir
injection, for intravenous use
Ibuzatrelvir + Remdesivir
Participants will receive ibuzatrelvir orally twice a day + IV remdesivir
ibuzatrelvir
tablet
remdesivir
injection, for intravenous use
Remdesivir
Participants will receive placebo for ibuzatrelvir orally twice a day + IV remdesivir
remdesivir
injection, for intravenous use
placebo for ibuzatrelvir
tablet
Interventions
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ibuzatrelvir
tablet
remdesivir
injection, for intravenous use
placebo for ibuzatrelvir
tablet
placebo for remdesivir
injection, for intravenous use
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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 lymphoma, 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 B-cell depleting therapies (eg, rituximab).
Exclusion Criteria
2. Receiving dialysis or have known severe renal impairment within 6 months of the screening visit
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.
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Hope Clinical Research, Inc.
Canoga Park, California, United States
UC Davis CTSC Clinical Research Center
Sacramento, California, United States
University of California Davis Health
Sacramento, California, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, United States
D&H Cancer Research Center LLC
Margate, Florida, United States
Velocity Clinical Research, Savannah
Savannah, Georgia, United States
Northwestern Memorial Hospital
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
Skylight Health Research - Burlington
Burlington, 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
Profound Research LLC
Farmington Hills, Michigan, United States
Revive Research Institute, Inc.
Farmington Hills, Michigan, United States
Holy Name Medical Center
Teaneck, New Jersey, United States
Duke Vaccine and Trials Unit
Durham, North Carolina, United States
Duke Vaccine and Trials Unit
Durham, North Carolina, United States
Duke Main Hospital and Clinics
Durham, North Carolina, United States
Duke University - Main Hospital and Clinics
Durham, North Carolina, United States
West Tennessee Research Institute
Jackson, Tennessee, United States
Zenos Clinical Research
Dallas, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
UZ Brussel
Brussels, Brussels Capital, Belgium
Jules Bordet Institute
Anderlecht, , Belgium
Icesp - Instituto Do Câncer Do Estado de São Paulo
São Paulo, , Brazil
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
Universitaetsklinikum Koeln
Cologne, North Rhine-Westphalia, Germany
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
BRCR Medical Center - Ponce
Ponce, , Puerto Rico
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
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
Countries
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Central Contacts
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2024-517671-21-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
C5091018
Identifier Type: -
Identifier Source: org_study_id