NCT07013474From ClinicalTrials.govRecruiting

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

AN INTERVENTIONAL EFFICACY AND SAFETY, PHASE 3, RANDOMIZED, DOUBLE-BLIND, 3-ARM STUDY TO INVESTIGATE IBUZATRELVIR IN ADULTS WITH SYMPTOMATIC COVID-19 WHO ARE SEVERELY IMMUNOCOMPROMISED

COVID-19 Infection

At a glance

Phase: Phase 3
Study type: Interventional
Sponsor: Pfizer
Enrolment target: 300
Started: 14 July 2025
Main results due: 28 September 2027
Study sites: 158
Registry updated: 25 September 2026

Can you take part?

Aged 18 years and over.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full 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.

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(158)

Hope Clinical Research, Inc.
Canoga Park, California, United States
Recruiting
Amicis Research Center - Granada Hills
Granada Hills, California, United States
Recruiting
Jacobs Medical Center at UC San Diego Health
La Jolla, California, United States
Recruiting
UC Davis CTSC Clinical Research Center
Sacramento, California, United States
Recruiting
University of California Davis Health
Sacramento, California, United States
Recruiting
UC San Diego Medical Center - Hillcrest
San Diego, California, United States
Recruiting
University of California San Diego Health
San Diego, California, United States
Recruiting
UCHealth Anschutz Inpatient Pavilion - Anschutz Medical Campus
Aurora, Colorado, United States
Recruiting
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
Recruiting
University of Colorado Clinical and Translational Research Center
Aurora, Colorado, United States
Recruiting
University of Colorado Hospital
Aurora, Colorado, United States
Recruiting
Georgetown University Medical Center
Washington D.C., District of Columbia, United States
Recruiting
BRP- Hialeah Hospital
Hialeah, Florida, United States
Recruiting
D&H Cancer Research Center LLC
Margate, Florida, United States
Recruiting
Kendall South Medical Center
Miami, Florida, United States
Recruiting
Velocity Clinical Research, Savannah
Savannah, Georgia, United States
Recruiting
Humphreys Diabetes Center
Boise, Idaho, United States
Recruiting
St. Luke's Idaho Elks Children's Pavilion
Boise, Idaho, United States
Recruiting
Northwestern Memorial Hospital
Chicago, Illinois, United States
Recruiting
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States
Recruiting
Johns Hopkins Hospital
Baltimore, Maryland, United States
Recruiting
Jadestone Clinical Research
Silver Spring, Maryland, United States
Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, United States
Recruiting
Clinical Trials Center
Boston, Massachusetts, United States
Recruiting
Clinical Trials Hub
Boston, Massachusetts, United States
Recruiting
University of Massachusetts Chan Medical School
Worcester, Massachusetts, United States
Recruiting
University of Michigan
Ann Arbor, Michigan, United States
Recruiting
Henry Ford Hospital
Detroit, Michigan, United States
Recruiting
Holy Name Medical Center
Teaneck, New Jersey, United States
Recruiting
Duke Vaccine and Trials Unit
Durham, North Carolina, United States
Recruiting
Duke Vaccine and Trials Unit
Durham, North Carolina, United States
Recruiting
Duke University - Main Hospital and Clinics
Durham, North Carolina, United States
Recruiting
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
Recruiting
University of Cincinnati College of Medicine (UC Holmes)
Cincinnati, Ohio, United States
Recruiting
TRC
Pittsburgh, Pennsylvania, United States
Recruiting
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Recruiting
UPMC Division of Infectious Disease Clinic
Pittsburgh, Pennsylvania, United States
Recruiting
UPMC Presbyterian IDS
Pittsburgh, Pennsylvania, United States
Recruiting
UPMC Presbyterian Shadyside
Pittsburgh, Pennsylvania, United States
Recruiting
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Recruiting
UPMC Shadyside IDS
Pittsburgh, Pennsylvania, United States
Recruiting
UPMC Shadyside
Pittsburgh, Pennsylvania, United States
Recruiting
Medical University of South Carolina Infectious Disease Clinic
Charleston, South Carolina, United States
Recruiting
Medical University of South Carolina Investigational Drug Services (IDS)
Charleston, South Carolina, United States
Recruiting
Medical University of South Carolina Investigational Drug Services Pharmacy
Charleston, South Carolina, United States
Recruiting
Medical University of South Carolina Research Nexus Clinic
Charleston, South Carolina, United States
Recruiting
Medical University of South Carolina Translational Research Nexus Clinic and Laboratory
Charleston, South Carolina, United States
Recruiting
Medical University of South Carolina
Charleston, South Carolina, United States
Recruiting
West Tennessee Research Institute
Jackson, Tennessee, United States
Recruiting
Zenos Clinical Research
Dallas, Texas, United States
Recruiting
Baylor Scott & White Health - Center for Advanced Heart and Lung Disease
Dallas, Texas, United States
Recruiting
Baylor Scott & White Research Institute - Clinical Trials Office
Dallas, Texas, United States
Recruiting
Baylor University Medical Center
Dallas, Texas, United States
Recruiting
Cockrell Center for Advanced Therapeutics
Houston, Texas, United States
Recruiting
Houston Methodist - Transplant Center
Houston, Texas, United States
Recruiting
Houston Methodist Hospital
Houston, Texas, United States
Recruiting
Memorial Hermann Hospital
Houston, Texas, United States
Recruiting
Scurlock CCAT clinic
Houston, Texas, United States
Recruiting
The University of Texas Health Science Center at Houston
Houston, Texas, United States
Recruiting
UT Physicians
Houston, Texas, United States
Recruiting

Showing 60 of 158 sites — filter to narrow it down. 146 of the 158 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07013474. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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