Recruiting

Ibuzatrelvir and Remdesivir in Severely Immunocompromised Adults with Symptomatic COVID-19

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What is being tested

ibuzatrelvir

+ placebo for remdesivir

+ remdesivir

Drug
Who is being recruted

COVID-19+9

+ Coronaviridae Infections

+ Infections

Over 18 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: July 2025
See protocol details

Summary

Principal SponsorPfizer
Study ContactPfizer CT.gov Call Center
Last updated: February 5, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 14, 2025

Actual date on which the first participant was enrolled.

This clinical trial is focused on exploring a medication called Ibuzatrelvir for treating COVID-19 in adults who have weakened immune systems. People with compromised immune systems, such as those with blood cancers or who have had organ transplants, struggle more with infections and can face severe illness from COVID-19. This study aims to see if Ibuzatrelvir, alone or combined with another antiviral drug called remdesivir, is more effective than remdesivir alone in treating these patients. The goal is to find a safe and effective treatment that can help this vulnerable group better manage their COVID-19 symptoms. Participants in this study will be adults diagnosed with COVID-19 and experiencing symptoms within the last five days. They will be divided into three groups: one group receiving only remdesivir, another only Ibuzatrelvir, and the last group receiving both medications. Ibuzatrelvir is taken orally twice a day, while remdesivir is administered daily through an IV. To ensure unbiased results, a placebo that resembles the actual medication but contains no active ingredients will be used. Participants will visit the clinic about ten times over 24 weeks for blood tests, nose swabs, and to complete questionnaires. This process helps researchers assess the safety and effectiveness of the treatments.

Official TitleAN 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
NCT07013474
Principal SponsorPfizer
Study ContactPfizer CT.gov Call Center
Last updated: February 5, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

300 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

COVID-19Coronaviridae InfectionsInfectionsLung DiseasesPneumoniaPneumonia, ViralRespiratory Tract DiseasesRespiratory Tract InfectionsRNA Virus InfectionsVirus DiseasesCoronavirus InfectionsNidovirales Infections

Criteria

1 inclusion criteria required to participate
18 years of age or older at screening who are non-hospitalized or hospitalized for observation or with the intent of administering the study intervention.
7 exclusion criteria prevent from participating
Prior participation in this trial or any clinical trial of ibuzatrelvir.
Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.
Has received any other antiviral for the treatment of the current COVID-19 infection
History of hypersensitivity or other contraindication to any of the components of the study interventions, as determined by the investigator
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Participants will receive ibuzatrelvir orally twice a day + IV placebo for remdesivir

Group II

Experimental
Participants will receive ibuzatrelvir orally twice a day + IV remdesivir

Group III

Experimental
Participants will receive placebo for ibuzatrelvir orally twice a day + IV remdesivir

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 115 locations

Recruiting

Hope Clinical Research, Inc.

Canoga Park, United StatesOpen Hope Clinical Research, Inc. in Google Maps
Recruiting

UC Davis CTSC Clinical Research Center

Sacramento, United States
Recruiting

University of California Davis Health

Sacramento, United States
Recruiting

UCHealth Anschutz Inpatient Pavilion - Anschutz Medical Campus

Aurora, United States
Recruiting
115 Study Centers