Recruiting

Phase 3

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

Sponsor:

Pfizer

Code:

NCT07013474

Conditions

COVID-19 Infection

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ibuzatrelvir

remdesivir

placebo for ibuzatrelvir

placebo for remdesivir

Study Details

Brief 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 at baseline with mild-to-moderate COVID-19.

Conditions

COVID-19 Infection

Study ID

NCT07013474

Start date

Jul 14, 2025

Status verified date

Aug, 2026

Completion date

Feb 25, 2028

Anticipated

Primary completion date

Sep 27, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. 18 years of age or older at screening who are non-hospitalized or hospitalized with mild to moderate COVID-19
2. Confirmed SARS-CoV-2 infection as determined by RAT (or other locally approved test) collected within 2 days prior to randomization. Initial onset of symptoms attributable to COVID-19 within 5 days prior to the day of randomization and at least 1 of the specified symptoms attributable to COVID-19 present on the day of randomization.
3. Severely immunocompromised due to:

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.

Exclusion Criteria:

1. Severe or critical COVID-19, or current need for supplemental oxygen.
2. Receiving dialysis or have current kidney failure (ie, eGFR consistently <15 mL/min)
3. Active liver disease
4. History of hypersensitivity or other contraindication to any of the components of the study interventions, as determined by the investigator
5. Suspected or confirmed concurrent active systemic infection other than COVID-19 that may interfere with the evaluation of response to the study intervention.
6. Life expectancy less than 30 days at study entry due to an underlying condition, in the judgement of the investigator.
7. Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
8. Has received any other antiviral for the treatment of the current COVID-19 infection
9. Current use of any prohibited concomitant medication(s) or unwillingness or inability to use a required concomitant medication(s).
10. Current or previous administration of an investigational product (drug or vaccine) within 30 days (or as determined by local requirement) or 5 half lives preceding the first dose of study intervention used in this study (whichever is longer). Authorized or products with conditional approval are not considered investigational.
11. Prior participation in this trial or any clinical trial of ibuzatrelvir.
12. Females who are pregnant, breastfeeding, or who are planning to become pregnant within the timeframe of the study.
13. 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.

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Ibuzatrelvir + Remdesivir

Participants will receive ibuzatrelvir orally twice a day + IV remdesivir

experimental: Ibuzatrelvir

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

experimental: Remdesivir

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

Interventions

ibuzatrelvir

tablet

remdesivir

injection, for intravenous use

placebo for ibuzatrelvir

tablet

placebo for remdesivir

injection, for intravenous use

Primary outcome measure

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 [ Time Frame: 38 days ]

Central Contacts and Locations

Central contacts

Pfizer CT.gov Call Center

1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations

Hope Clinical Research, Inc.

Recruiting

Canoga Park, California, United States, 91303

Amicis Research Center - Granada Hills

Recruiting

Granada Hills, California, United States, 91344

Jacobs Medical Center at UC San Diego Health

Recruiting

La Jolla, California, United States, 92037

UC Davis CTSC Clinical Research Center

Recruiting

Sacramento, California, United States, 95817

University of California Davis Health

Recruiting

Sacramento, California, United States, 95817

UC San Diego Medical Center - Hillcrest

Recruiting

San Diego, California, United States, 92103

University of California San Diego Health

Recruiting

San Diego, California, United States, 92103

UCHealth Anschutz Inpatient Pavilion - Anschutz Medical Campus

Recruiting

Aurora, Colorado, United States, 80045

University of Colorado Anschutz Medical Campus

Recruiting

Aurora, Colorado, United States, 80045

University of Colorado Clinical and Translational Research Center

Recruiting

Aurora, Colorado, United States, 80045

University of Colorado Hospital

Recruiting

Aurora, Colorado, United States, 80045

Georgetown University Medical Center

Recruiting

Washington D.C., District of Columbia, United States, 20007

BRP- Hialeah Hospital

Recruiting

Hialeah, Florida, United States, 33013

D&H Cancer Research Center LLC

Recruiting

Margate, Florida, United States, 33063

Kendall South Medical Center

Recruiting

Miami, Florida, United States, 33185

Velocity Clinical Research, Savannah

Recruiting

Savannah, Georgia, United States, 31406

Humphreys Diabetes Center

Recruiting

Boise, Idaho, United States, 83702

St. Luke's Idaho Elks Children's Pavilion

Recruiting

Boise, Idaho, United States, 83712

Northwestern Memorial Hospital

Recruiting

Chicago, Illinois, United States, 60611

Northwestern University Feinberg School of Medicine

Recruiting

Chicago, Illinois, United States, 60611

Johns Hopkins Hospital

Recruiting

Baltimore, Maryland, United States, 21287

Jadestone Clinical Research

Recruiting

Silver Spring, Maryland, United States, 20904

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Clinical Trials Center

Recruiting

Boston, Massachusetts, United States, 02115

Clinical Trials Hub

Recruiting

Boston, Massachusetts, United States, 02115

University of Massachusetts Chan Medical School

Recruiting

Worcester, Massachusetts, United States, 01655

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Henry Ford Hospital

Recruiting

Detroit, Michigan, United States, 48202

Holy Name Medical Center

Recruiting

Teaneck, New Jersey, United States, 07666

Duke Vaccine and Trials Unit

Recruiting

Durham, North Carolina, United States, 27703

Duke Vaccine and Trials Unit

Recruiting

Durham, North Carolina, United States, 27705

Duke University - Main Hospital and Clinics

Recruiting

Durham, North Carolina, United States, 27710

University of Cincinnati Medical Center

Recruiting

Cincinnati, Ohio, United States, 45219

University of Cincinnati College of Medicine (UC Holmes)

Recruiting

Cincinnati, Ohio, United States, 45267

TRC

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

University of Pittsburgh Medical Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

UPMC Division of Infectious Disease Clinic

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

UPMC Presbyterian IDS

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

UPMC Presbyterian Shadyside

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

UPMC Hillman Cancer Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

UPMC Shadyside IDS

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

UPMC Shadyside

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

Medical University of South Carolina Infectious Disease Clinic

Recruiting