RECRUITING

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

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Conditions

COVID-19 Infectionpneumoniarespiratory tract infectionscoronavirus infectionRNA virus infectionlung diseasepneumonia, viralinfectionsvirusviral protease inhibitorprotease inhibitorenzyme inhibitorsevere immunocompromiseanti-viral agentsanti-infectivesibuzatrelvirremdesivirCOVID-19

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-07-14
Study Completion:2027-05-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07013474

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 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. 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. 3. Severely immunocompromised due to:
  4. * Solid organ or islet cell transplant recipient who is receiving immunosuppressive therapy;
  5. * Active hematologic malignancy (eg, chronic lymphocytic leukemia, non-Hodgkin lymphoma, multiple myeloma, acute leukemia);
  6. * Receipt of CAR-T-cell therapy or HCT either within 2 years of transplantation or who are receiving immunosuppressive therapy;
  7. * Currently receiving or recently received B-cell depleting therapies (eg, rituximab), where the immunosuppressive effect is still ongoing.
  1. 1. Severe COVID-19, or current need for supplemental oxygen for treatment of COVID-19.
  2. 2. Receiving dialysis or have current kidney failure (ie, eGFR consistently \<15 mL/min/1.73 m2)
  3. 3. Active liver disease
  4. 4. History of hypersensitivity or other contraindication to any of the components of the study interventions, as determined by the investigator
  5. 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. 6. Life expectancy less than 30 days at study entry due to an underlying condition, in the judgement of the investigator.
  7. 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. 8. Has received any other antiviral for the treatment of the current COVID-19 infection
  9. 9. Current use of any prohibited concomitant medication(s) or unwillingness or inability to use a required concomitant medication(s).
  10. 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. 11. Prior participation in this trial or any clinical trial of ibuzatrelvir.
  12. 12. Females who are pregnant, breastfeeding, or who are planning to become pregnant within the timeframe of the study.
  13. 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.

Contacts and Locations

Study Contact

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

Principal Investigator

Pfizer CT.gov Call Center
STUDY_DIRECTOR
Pfizer

Study Locations (Sites)

Hope Clinical Research, Inc.
Canoga Park, California, 91303
United States
Amicis Research Center - Granada Hills
Granada Hills, California, 91344
United States
UC Davis CTSC Clinical Research Center
Sacramento, California, 95817
United States
University of California Davis Health
Sacramento, California, 95817
United States
UCHealth Anschutz Inpatient Pavilion - Anschutz Medical Campus
Aurora, Colorado, 80045
United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
United States
University of Colorado Clinical and Translational Research Center
Aurora, Colorado, 80045
United States
University of Colorado Hospital
Aurora, Colorado, 80045
United States
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
United States
D&H Cancer Research Center LLC
Margate, Florida, 33063
United States
Velocity Clinical Research, Savannah
Savannah, Georgia, 31406
United States
Humphreys Diabetes Center
Boise, Idaho, 83702
United States
Idaho Elk's Children's Pavillion
Boise, Idaho, 83712
United States
St. Luke's Children's
Boise, Idaho, 83712
United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611
United States
Northwestern University Division of Infectious Disease
Chicago, Illinois, 60611
United States
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
United States
Johns Hopkins Hospital
Baltimore, Maryland, 21287
United States
Jadestone Clinical Research
Silver Spring, Maryland, 20904
United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States
Clinical Trials Center
Boston, Massachusetts, 02115
United States
Clinical Trials Hub
Boston, Massachusetts, 02115
United States
Skylight Health Research - Burlington
Burlington, Massachusetts, 01803
United States
University of Massachusetts Chan Medical School
Worcester, Massachusetts, 01655
United States
University of Michigan
Ann Arbor, Michigan, 48109
United States
Henry Ford Hospital
Detroit, Michigan, 48202
United States
Profound Research LLC
Farmington Hills, Michigan, 48334
United States
Revive Research Institute, Inc.
Farmington Hills, Michigan, 48334
United States
Holy Name Medical Center
Teaneck, New Jersey, 07666
United States
Duke Vaccine and Trials Unit
Durham, North Carolina, 27703
United States
Duke Vaccine and Trials Unit
Durham, North Carolina, 27705
United States
Duke Main Hospital and Clinics
Durham, North Carolina, 27710
United States
Duke University - Main Hospital and Clinics
Durham, North Carolina, 27710
United States
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219
United States
University of Cincinnati College of Medicine (UC Holmes)
Cincinnati, Ohio, 45267
United States
West Tennessee Research Institute
Jackson, Tennessee, 38305
United States
Zenos Clinical Research
Dallas, Texas, 75230
United States
Houston Methodist Hospital
Houston, Texas, 77030
United States
Seattle Rheumatology Associates
Seattle, Washington, 98104
United States
Swedish Ambulatory Infusion Center- First Hill
Seattle, Washington, 98104
United States
Swedish Cancer Institute Treatment Center
Seattle, Washington, 98104
United States
Swedish Medical Center- Innovative Therapeutics & Research Unit
Seattle, Washington, 98104
United States
Swedish Organ Transplant and Liver Center
Seattle, Washington, 98104
United States
Swedish Medical Center - First Hill Campus
Seattle, Washington, 98122
United States

Collaborators and Investigators

Sponsor: Pfizer

  • Pfizer CT.gov Call Center, STUDY_DIRECTOR, Pfizer

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-14
Study Completion Date2027-05-06

Study Record Updates

Study Start Date2025-07-14
Study Completion Date2027-05-06

Terms related to this study

Keywords Provided by Researchers

  • COVID-19 infection
  • pneumonia
  • respiratory tract infections
  • coronavirus infection
  • RNA virus infection
  • lung disease
  • pneumonia, viral
  • infections
  • virus
  • viral protease inhibitor
  • protease inhibitor
  • enzyme inhibitor
  • severe immunocompromise
  • anti-viral agents
  • anti-infectives
  • ibuzatrelvir
  • remdesivir
  • COVID-19

Additional Relevant MeSH Terms

  • COVID-19 Infection