Phase 3 Study of Ibuzatrelvir With or Without Remdesivir to Treat Symptomatic COVID-19 in Severely Immunocompromised Adults

What this Trial Is About

Researchers are evaluating the effects of a study medicine called ibuzatrelvir, alone and in combination with remdesivir, for treating symptomatic COVID-19 in adults who are severely immunocompromised. This Phase 3 clinical trial compares ibuzatrelvir with remdesivir to remdesivir alone to assess safety and effectiveness in non-hospitalized or hospitalized patients who do not require supplemental oxygen. Immunocompromised patients often have difficulty fighting infections and may benefit from extended or combination antiviral treatments. Participants are randomly assigned to one of three groups one receiving both ibuzatrelvir taken orally twice daily and intravenous remdesivir, one receiving ibuzatrelvir with a placebo infusion, and one receiving remdesivir with a placebo pill. Placebos that look like the study medicines are used to keep the groups similar in appearance. This design helps researchers determine if adding ibuzatrelvir improves treatment compared to remdesivir alone. Participants will attend about 10 study visits over 24 weeks, including clinic visits for blood tests, nasal swabs collected both at the clinic and at home, and questionnaires. Researchers will measure outcomes such as symptom improvement, viral levels, COVID-19-related healthcare visits, and safety events. The study carefully monitors participants throughout to understand the treatment effects and safety over time.

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