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Ibuzatrelvir for COVID-19 in Severely Immunocompromised Adults

This study is investigating a medicine called ibuzatrelvir for adults with COVID-19 who have weakened immune systems (severely immunocompromised). These patients often have a harder time fighting off infections. The study will compare ibuzatrelvir, alone or with remdesivir (an existing COVID-19 treatment), against remdesivir alone. All participants will receive active COVID-19 treatment. Researchers want to see if ibuzatrelvir is effective and safe in treating COVID-19 in this group. You may be able to join if you are 18 or older, have a confirmed COVID-19 infection, are severely immunocompromised, and have had COVID-19 symptoms for 5 days or less. The study aims to enroll 300 participants, but its current status is unclear.

Study design
This is a Phase 3, randomized, active-controlled, double-blinded, double-dummy study involving 300 participants. Participants will be assigned to one of three treatment groups: ibuzatrelvir, remdesivir, or both.
What's involved
Ibuzatrelvir will be taken by mouth twice daily, and remdesivir is given as an IV infusion daily. The study will measure outcomes at 38 days.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at 38 days, suggesting follow-up for at least this duration.

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NCT07013474

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
Pfizer
~300 participants
Updated 2026-08-25 on ClinicalTrials.gov
What's tested:ibuzatrelvirremdesivirplacebo for ibuzatrelvirplacebo for remdesivir

At a glance

Recruiting sites
143 of 152 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The difference in the proportion of patients meeting the primary composite endpoint, between ibuzatrelvir and remdesivir vs remdesivir groups in symptomatic adult participants with COVID-19 who are severely immunocompromised
Measured over 38 days

Conditions

COVID-19 Infection

Explore related trials

COVID-19 Infection

Where it's being run

152 sites across 75 states
Washington9
Pennsylvania8
Texas8
California7
South Carolina6
Turkey (Türkiye)6
Colorado4
Massachusetts4

Study leadership

  • Pfizer CT.gov Call Center · STUDY_DIRECTOR · Pfizer

Who to contact

Pfizer CT.gov Call Center
[email protected]
1-800-718-1021
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Solid organ or islet cell transplant recipient who is receiving immunosuppressive therapy;
Active hematologic malignancy (eg, chronic lymphocytic leukemia, non-Hodgkin lymphoma, multiple myeloma, acute leukemia);
Receipt of CAR-T-cell therapy or HCT either within 2 years of transplantation or who are receiving immunosuppressive therapy;
Currently receiving or recently received B-cell depleting therapies (eg, rituximab), where the immunosuppressive effect is still ongoing.

What this trial measures

  • The difference in the proportion of patients meeting the primary composite endpoint, between ibuzatrelvir and remdesivir vs remdesivir groups in symptomatic adult participants with COVID-19 who are severely immunocompromised38 days

    The difference in the proportion of participants with the composite endpoint of a) Progression to severe COVID-19 or all-cause mortality by Day 38, or b) Evidence of recurrent or persistent SARS-CoV-2 infection