Clinical Trial

A Study to Learn About a Study Medicine Called Ibuzatrelvir in Adult and Adolescent Patients With COVID-19 Who Are Not Hospitalized But Are at Risk For Severe Disease

Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
The purpose of the study is to evaluate whether ibuzatrelvir is effective and safe in adults and adolescents with COVID-19 who do not need to be in the hospital but who are at high risk for progression to severe disease. Eligible participants will be randomly assigned (by chance) to receive ibuzatrelvir or matching placebo orally for 5 days. Co-administration of locally available standard of care is allowed. The total duration of the study is around 6 months.
Protocol Amendment History 3 changes
notable Trial sites expanded: 248 -> 253 locations 2026-08-01
notable Trial sites expanded: 103 -> 243 locations 2026-05-15
notable Trial sites reduced: 237 -> 103 locations 2026-05-06
Trial Details
NCT Number NCT06679140
Lead Sponsor Pfizer
Conditions COVID-19 SARS-CoV-2 Infection
Enrollment 2,330 participants
Start Date 2024-12-08
Primary Completion 2027-10-03 (estimated)
Study Completion 2028-03-02 (estimated)
Updated on ClinicalTrials.gov 2026-08-14