Clinical Trial

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

Recruiting Phase 3
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.
Protocol Amendment History 8 changes
notable Trial sites expanded: 148 -> 152 locations 2026-07-31
notable Trial sites expanded: 141 -> 147 locations 2026-06-17
notable Primary completion pushed: 2026-12-06 -> 2027-09-27 2026-05-29
minor Completion pushed: 2027-05-06 -> 2028-02-25 2026-05-29
notable Trial sites expanded: 54 -> 138 locations 2026-05-16
notable Trial sites reduced: 132 -> 54 locations 2026-05-06
notable Trial sites expanded: 129 -> 132 locations 2026-04-25
notable Trial sites expanded: 117 -> 129 locations 2026-04-14
Trial Details
NCT Number NCT07013474
Lead Sponsor Pfizer
Conditions COVID-19 Infection
Enrollment 300 participants
Start Date 2025-07-14
Primary Completion 2027-09-27 (estimated)
Study Completion 2028-02-25 (estimated)
Updated on ClinicalTrials.gov 2026-08-14