What is ibuzatrelvir studying for COVID-19 in severely immunocompromised adults?

Ibuzatrelvir is being studied to understand its safety and effectiveness alone or with remdesivir for treating COVID-19 in adults with weakened immune systems. This trial aims to find better treatment options for those who may have trouble fighting the virus. Pfizer is leading this research to address this important patient group.

Who may be eligible for this COVID-19 clinical trial?

Adults 18 years or older with confirmed COVID-19 who are severely immunocompromised due to conditions like organ transplant or blood cancers may be eligible. Participants can be male or female but must not need supplemental oxygen for COVID-19. Please review eligibility criteria for more details.

Is there any cost to participate in this COVID-19 clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for their own travel needs.

Actively Recruiting

Phase 3

Age: 18Years +

All Genders

ID07013474

Study of Ibuzatrelvir Alone and With Remdesivir for Symptomatic COVID-19 in Severely Immunocompromised Adults

Led by Pfizer · Updated on 2026-06-05

300

Participants Needed

141

Research Sites

21 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the study medicine ibuzatrelvir for treating symptomatic COVID-19 in adults who are severely immunocompromised. This Phase 3 trial compares the safety and effectiveness of ibuzatrelvir alone and combined with remdesivir to remdesivir alone. The study focuses on patients who may have difficulty fighting infections and risk persistent or severe illness due to weakened immune systems from conditions like blood cancers or organ transplants. Participants are randomly assigned to one of three groups: ibuzatrelvir taken orally twice daily with a placebo injection, ibuzatrelvir twice daily plus remdesivir given as a daily IV infusion, or remdesivir with a placebo tablet. The double-blind design means neither participants nor staff know which treatment is given. Placebos are used to match the appearance of active medicines. The study treatment period will be followed by monitoring for safety and effects. Participants will attend about 10 visits over 24 weeks, including clinic visits for blood tests and nasal swabs, some collected at home by participants. They will complete questionnaires about symptoms and health. Researchers will measure outcomes such as symptom relief, viral levels in nasal swabs, recurrence of infection, need for additional COVID-19 treatments or hospitalization, and any side effects. The main comparison is the proportion of patients who meet the primary health outcome within 38 days.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Adults aged 18 years or older who are non-hospitalized or hospitalized for observation or study treatment
Confirmed COVID-19 infection by approved test within 2 days before randomization
Onset of COVID-19 symptoms within 5 days before randomization with at least one symptom present
Severely immunocompromised due to organ transplant with immunosuppressive therapy, active blood cancers, CAR-T-cell therapy or hematopoietic cell transplantation within 2 years or ongoing immunosuppressive therapy, or current/recent B-cell depleting therapies

You will not qualify if you...

Severe COVID-19 or need for supplemental oxygen for COVID-19 treatment
Receiving dialysis or having current kidney failure with eGFR less than 15 mL/min/1.73 m2
Active liver disease
Allergy or contraindication to study medications
Suspected or confirmed active infection besides COVID-19 interfering with study
Life expectancy less than 30 days due to other conditions
Medical or psychiatric conditions increasing risk or judged inappropriate by investigator
Received other antivirals for current COVID-19 infection
Current use or unwillingness to use prohibited medications
Recent investigational product use within 30 days or 5 half-lives
Prior participation in this or any ibuzatrelvir trial
Pregnant, breastfeeding, or planning pregnancy during the study
Investigator site staff and their close family members involved in the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 38 days

Participants receive active treatment with ibuzatrelvir, remdesivir, or both, to study the safety and effectiveness for COVID-19 in severely immunocompromised adults.

About 10 visits over 24 weeks including clinic visits, blood work, and nasal swabs collected in the clinic and at home

Trial Site Locations

Total: 141 locations

Hope Clinical Research, Inc.

Canoga Park, California, United States, 91303

Actively Recruiting

Amicis Research Center - Granada Hills

Granada Hills, California, United States, 91344

Actively Recruiting

Jacobs Medical Center at UC San Diego Health

La Jolla, California, United States, 92037

Actively Recruiting

UC Davis CTSC Clinical Research Center

Sacramento, California, United States, 95817

Actively Recruiting

University of California Davis Health

Sacramento, California, United States, 95817

Actively Recruiting

UC San Diego Medical Center - Hillcrest

San Diego, California, United States, 92103

Actively Recruiting

University of California San Diego Health

San Diego, California, United States, 92103

Actively Recruiting

UCHealth Anschutz Inpatient Pavilion - Anschutz Medical Campus

Aurora, Colorado, United States, 80045

Actively Recruiting

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States, 80045

Actively Recruiting

University of Colorado Clinical and Translational Research Center

Aurora, Colorado, United States, 80045

Actively Recruiting

University of Colorado Hospital

Aurora, Colorado, United States, 80045

Actively Recruiting

Georgetown University Medical Center

Washington D.C., District of Columbia, United States, 20007

Actively Recruiting

BRP- Hialeah Hospital

Hialeah, Florida, United States, 33013

Actively Recruiting

D&H Cancer Research Center LLC

Margate, Florida, United States, 33063

Actively Recruiting

Kendall South Medical Center

Miami, Florida, United States, 33185

Actively Recruiting

Velocity Clinical Research, Savannah

Savannah, Georgia, United States, 31406

Actively Recruiting

Humphreys Diabetes Center

Boise, Idaho, United States, 83702

Actively Recruiting

St. Luke's Idaho Elks Children's Pavilion

Boise, Idaho, United States, 83712

Actively Recruiting

Northwestern Memorial Hospital

Chicago, Illinois, United States, 60611

Actively Recruiting

Northwestern University Feinberg School of Medicine

Chicago, Illinois, United States, 60611

Actively Recruiting

Johns Hopkins Hospital

Baltimore, Maryland, United States, 21287

Actively Recruiting

Jadestone Clinical Research

Silver Spring, Maryland, United States, 20904

Actively Recruiting

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02115

Actively Recruiting

Clinical Trials Center

Boston, Massachusetts, United States, 02115

Actively Recruiting

Clinical Trials Hub

Boston, Massachusetts, United States, 02115

Actively Recruiting

Skylight Health Research, - Burlington

Burlington, Massachusetts, United States, 01803

Actively Recruiting

University of Massachusetts Chan Medical School

Worcester, Massachusetts, United States, 01655

Actively Recruiting

University of Michigan

Ann Arbor, Michigan, United States, 48109

Actively Recruiting

Henry Ford Hospital

Detroit, Michigan, United States, 48202

Actively Recruiting

Profound Research LLC

Farmington Hills, Michigan, United States, 48334

Actively Recruiting

Revive Research Institute, Inc.

Farmington Hills, Michigan, United States, 48334

Actively Recruiting

Holy Name Medical Center

Teaneck, New Jersey, United States, 07666

Actively Recruiting

Duke Vaccine and Trials Unit

Durham, North Carolina, United States, 27703

Actively Recruiting

Duke Vaccine and Trials Unit

Durham, North Carolina, United States, 27705

Actively Recruiting

Duke University - Main Hospital and Clinics

Durham, North Carolina, United States, 27710

Actively Recruiting

University of Cincinnati Medical Center

Cincinnati, Ohio, United States, 45219

Actively Recruiting

University of Cincinnati College of Medicine (UC Holmes)

Cincinnati, Ohio, United States, 45267

Actively Recruiting

TRC