NCT07013474

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

AN INTERVENTIONAL EFFICACY AND SAFETY, PHASE 3, RANDOMIZED, DOUBLE-BLIND, 3-ARM STUDY TO INVESTIGATE IBUZATRELVIR IN ADULTS WITH SYMPTOMATIC COVID-19 WHO ARE SEVERELY IMMUNOCOMPROMISED

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The purpose of this clinical trial is to learn about a study medicine called Ibuzatrelvir for the possible treatment of COVID-19 in immunocompromised patients. Immunocompromised patients with COVID-19 have more difficulty fighting infections and are at risk for persistent infections and progression to severe illness. This patient population may benefit from extended antiviral treatment durations, or a combination of antiviral therapies. This study will evaluate the efficacy and safety of ibuzatrelvir with and without remdesivir compared with remdesivir alone for the treatment of symptomatic COVID-19 in adult participants who are severely immunocompromised. The study is seeking adult male and female participants who: * Have a confirmed COVID-19 infection * Are severely immunocompromised due to blood cancers, organ transplant, certain medications or therapies * Have experienced the onset of signs or symptoms of COVID-19 within the past 5 days and are currently experiencing at least one of them. All of the participants in this study will receive active treatment for COVID-19, and will be randomized to one of three treatment arms. One-third will received remdesivir, one-third will receive ibuzatrelvir, and one third will receive both remdesivir and ibuzatrelvir. Ibuzatrelvir will be taken by mouth twice daily, and remdesivir is given as an IV infusion daily. Placebos that look like the study medicines but do not have any medication will be given to make the 3 treatment arms appear to be the same. The study will compare the experiences of people receiving ibuzatrelvir with and without remdesivir to those of the people who only received remdesivir for COVID-19. This will help decide if ibuzatrelvir is safe and effective. Participants will attend about 10 study visits over 24 weeks. During this time, they will have: * visits at the study clinic * blood work * swabs of the nose that are collected in the clinic and also by participants at home * questionnaires

Conditions

• COVID-19 Infection

Interventions

Type	Name	Description
DRUG	ibuzatrelvir	tablet
DRUG	remdesivir	injection, for intravenous use
DRUG	placebo for ibuzatrelvir	tablet
DRUG	placebo for remdesivir	injection, for intravenous use

Timeline

• Start date: 2025-07-14
• Primary completion: 2026-12-06
• Completion: 2027-05-06
• First posted: 2025-06-10
• Last updated: 2026-04-13

Locations

129 sites across 18 countries: United States, Argentina, Belgium, Brazil, Denmark, France, Germany, Greece, Japan, Mexico, Netherlands, Puerto Rico, Slovakia, South Korea, Spain, Sweden, Taiwan, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study