drugset / Trial / NCT07013474
A Study to Learn About the Study Medicine Ibuzatrelvir in Adults With COVID-19 Who Are Severely Immunocompromised
RandomizedParallel-groupTriple-blindTreatment
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.
Timeline
- Start
- 2025-07-14
- Primary completion
- 2027-09-27
- Completion
- 2028-02-25
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ibuzatrelvir | Small molecule | — | Oral |
| Subject | Remdesivir | Small molecule | — | Intravenous |