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Clinical Trials in the USA / NCT07013474
Recruiting Phase 3

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

NCT07013474 · tracked via the Priya Life Science USA tracker
Sponsor
Pfizer
Phase
Phase 3
Started
2025-07-14
Last updated
2026-08-25

Condition(s) studied

COVID-19 Infection

Investigational drug(s) / intervention(s)

ibuzatrelvirremdesivirplacebo for ibuzatrelvirplacebo for remdesivir

ibuzatrelvir: tablet

remdesivir: injection, for intravenous use

placebo for ibuzatrelvir: tablet

placebo for remdesivir: injection, for intravenous use

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (152)

FacilityCityRegionStatus
Hope Clinical Research, Inc. Canoga Park California Recruiting
Amicis Research Center - Granada Hills Granada Hills California Recruiting
Jacobs Medical Center at UC San Diego Health La Jolla California Recruiting
UC Davis CTSC Clinical Research Center Sacramento California Recruiting
University of California Davis Health Sacramento California Recruiting
UC San Diego Medical Center - Hillcrest San Diego California Recruiting
University of California San Diego Health San Diego California Recruiting
UCHealth Anschutz Inpatient Pavilion - Anschutz Medical Campus Aurora Colorado Recruiting
University of Colorado Anschutz Medical Campus Aurora Colorado Recruiting
University of Colorado Clinical and Translational Research Center Aurora Colorado Recruiting
University of Colorado Hospital Aurora Colorado Recruiting
Georgetown University Medical Center Washington D.C. District of Columbia Recruiting
BRP- Hialeah Hospital Hialeah Florida Recruiting
D&H Cancer Research Center LLC Margate Florida Recruiting
Kendall South Medical Center Miami Florida Recruiting
Velocity Clinical Research, Savannah Savannah Georgia Recruiting
Humphreys Diabetes Center Boise Idaho Recruiting
St. Luke's Idaho Elks Children's Pavilion Boise Idaho Recruiting
Northwestern Memorial Hospital Chicago Illinois Recruiting
Northwestern University Feinberg School of Medicine Chicago Illinois Recruiting
Johns Hopkins Hospital Baltimore Maryland Recruiting
Jadestone Clinical Research Silver Spring Maryland Recruiting
Brigham and Women's Hospital Boston Massachusetts Recruiting
Clinical Trials Center Boston Massachusetts Recruiting
Clinical Trials Hub Boston Massachusetts Recruiting
University of Massachusetts Chan Medical School Worcester Massachusetts Recruiting
University of Michigan Ann Arbor Michigan Recruiting
Henry Ford Hospital Detroit Michigan Recruiting
Holy Name Medical Center Teaneck New Jersey Recruiting
Duke Vaccine and Trials Unit Durham North Carolina Recruiting
Duke Vaccine and Trials Unit Durham North Carolina Recruiting
Duke University - Main Hospital and Clinics Durham North Carolina Recruiting
University of Cincinnati Medical Center Cincinnati Ohio Recruiting
University of Cincinnati College of Medicine (UC Holmes) Cincinnati Ohio Recruiting
TRC Pittsburgh Pennsylvania Recruiting
University of Pittsburgh Medical Center Pittsburgh Pennsylvania Recruiting
UPMC Division of Infectious Disease Clinic Pittsburgh Pennsylvania Recruiting
UPMC Presbyterian IDS Pittsburgh Pennsylvania Recruiting
UPMC Presbyterian Shadyside Pittsburgh Pennsylvania Recruiting
UPMC Hillman Cancer Center Pittsburgh Pennsylvania Recruiting

+ 112 more sites — see the full list on the official registry below.

On this site

📄 Veklury (remdesivir) drug profile →

More Pfizer trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07013474 on ClinicalTrials.gov ↗ ← All trials in the USA