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

Purpose

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.

Condition

  • COVID-19 Infection

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. 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. 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 COVID-19, or current need for supplemental oxygen for treatment of COVID-19. 2. Receiving dialysis or have current kidney failure (ie, eGFR consistently <15 mL/min/1.73 m2) 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

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)
Masking Description
This is a double-blind study, with required dedicated unblinded staff for dose preparation for remdesivir and placebo for remdesivir.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Ibuzatrelvir 		Participants will receive ibuzatrelvir orally twice a day + IV placebo for remdesivir
  • Drug: ibuzatrelvir
    tablet
  • Drug: placebo for remdesivir
    injection, for intravenous use
Experimental
Ibuzatrelvir + Remdesivir 		Participants will receive ibuzatrelvir orally twice a day + IV remdesivir
  • Drug: ibuzatrelvir
    tablet
  • Drug: remdesivir
    injection, for intravenous use
    Other names:
    • veklury
Experimental
Remdesivir 		Participants will receive placebo for ibuzatrelvir orally twice a day + IV remdesivir
  • Drug: remdesivir
    injection, for intravenous use
    Other names:
    • veklury
  • Drug: placebo for ibuzatrelvir
    tablet

Recruiting Locations

Hope Clinical Research, Inc.
Canoga Park, California 91303

Amicis Research Center - Granada Hills
Granada Hills, California 91344

UC Davis CTSC Clinical Research Center
Sacramento, California 95817

University of California Davis Health
Sacramento, California 95817

UCHealth Anschutz Inpatient Pavilion - Anschutz Medical Campus
Aurora, Colorado 80045

University of Colorado Anschutz Medical Campus
Aurora, Colorado 80045

University of Colorado Clinical and Translational Research Center
Aurora, Colorado 80045

University of Colorado Hospital
Aurora, Colorado 80045

Georgetown University Medical Center
Washington D.C., District of Columbia 20007

BRP- Hialeah Hospital
Hialeah, Florida 33013

D&H Cancer Research Center LLC
Margate, Florida 33063

Kendall South Medical Center
Miami, Florida 33185

Velocity Clinical Research, Savannah
Savannah, Georgia 31406

Humphreys Diabetes Center
Boise, Idaho 83702

St. Luke's Idaho Elks Children's Pavilion
Boise, Idaho 83712

Northwestern Memorial Hospital
Chicago, Illinois 60611

Northwestern University Feinberg School of Medicine
Chicago, Illinois 60611

Johns Hopkins Hospital
Baltimore, Maryland 21287

Jadestone Clinical Research
Silver Spring, Maryland 20904

Brigham and Women's Hospital
Boston, Massachusetts 02115

Clinical Trials Center
Boston, Massachusetts 02115

Clinical Trials Hub
Boston, Massachusetts 02115

Skylight Health Research - Burlington
Burlington, Massachusetts 01803

University of Massachusetts Chan Medical School
Worcester, Massachusetts 01655

University of Michigan
Ann Arbor, Michigan 48109

Henry Ford Hospital
Detroit, Michigan 48202

Profound Research LLC
Farmington Hills, Michigan 48334

Revive Research Institute, Inc.
Farmington Hills, Michigan 48334

Holy Name Medical Center
Teaneck, New Jersey 07666

Duke Vaccine and Trials Unit
Durham, North Carolina 27703

Duke Vaccine and Trials Unit
Durham, North Carolina 27705

Duke University - Main Hospital and Clinics
Durham, North Carolina 27710

University of Cincinnati Medical Center
Cincinnati, Ohio 45219

University of Cincinnati College of Medicine (UC Holmes)
Cincinnati, Ohio 45267

West Tennessee Research Institute
Jackson, Tennessee 38305

Zenos Clinical Research
Dallas, Texas 75230

Houston Methodist Hospital
Houston, Texas 77030

Memorial Hermann Hospital
Houston, Texas 77030

The University of Texas Health Science Center at Houston
Houston, Texas 77030

UT Physicians
Houston, Texas 77030

More Details

NCT ID
NCT07013474
Status
Recruiting
Sponsor
Pfizer

Study Contact

Pfizer CT.gov Call Center
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com

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