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RECRUITING

NCT07013474

PHASE3

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

Sponsor: Pfizer

View on ClinicalTrials.gov

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 for observation or study intervention administration but do not require supplemental oxygen for COVID-19.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2025-07-14

Completion Date

2027-05-06

Last Updated

2026-03-04

Healthy Volunteers

Conditions

COVID-19 Infection

Interventions

DRUG

ibuzatrelvir

tablet

DRUG

remdesivir

injection, for intravenous use

DRUG

placebo for ibuzatrelvir

tablet

DRUG

placebo for remdesivir

injection, for intravenous use

Inclusion Criteria: 1. 18 years of age or older at screening who are non-hospitalized or hospitalized for observation or with the intent of administering the study intervention. 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 COVID-19, or current need for supplemental oxygen for treatment of COVID-19. 2. Receiving dialysis or have current kidney failure (ie, eGFR consistently \<15 mL/min/1.73 m2) 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.

Locations (117)

Hope Clinical Research, Inc.

Canoga Park, California, United States

Amicis Research Center - Granada Hills

Granada Hills, California, United States

UC Davis CTSC Clinical Research Center

Sacramento, California, United States

University of California Davis Health

Sacramento, 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

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 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

West Tennessee Research Institute

Jackson, Tennessee, United States

Zenos Clinical Research

Dallas, Texas, United States

Houston Methodist Hospital

Houston, Texas, United States

Memorial Hermann Hospital

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