A Study to Learn About the Study Medicine Ibuzatrelvir in Adults With COVID-19 Who Are Severely Immunocompromised
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Primary outcome measure(s)
- The difference in the proportion of patients meeting the primary composite endpoint, between ibuzatrelvir and remdesivir vs remdesivir groups in symptomatic adult participants with COVID-19 who are severely immunocompromised — 38 days
The difference in the proportion of participants with the composite endpoint of a) Progression to severe COVID-19 or all-cause mortality by Day 38, or b) Evidence of recurrent or persistent SARS-CoV-2 infection
Trial sites (159)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
| NYU Langone Health | New York | New York | 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 |
+ 119 more sites — see the full list on the official registry below.
On this site
📄 Veklury (remdesivir) drug profile →More Pfizer trials in Belgium
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 Belgium