drugset / Trial / NCT07013474

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

NCT07013474

Phase 3 Recruiting 300 enrolled Pfizer
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

EvaluationDrugModalityDoseRoute
Subject Ibuzatrelvir Small molecule Oral
Subject Remdesivir Small molecule Intravenous

Indications