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RECRUITINGPhase 3INTERVENTIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 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. Who Should NOT Join This Trial: 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

ibuzatrelvir

tablet

DRUG

remdesivir

injection, for intravenous use

DRUG

placebo for ibuzatrelvir

tablet

DRUG

placebo for remdesivir

injection, for intravenous use

Locations (20)

Hope Clinical Research, Inc.
Canoga Park, California, United States
Amicis Research Center - Granada Hills
Granada Hills, California, United States
UC Davis CTSC Clinical Research Center
Sacramento, California, United States
University of California Davis Health
Sacramento, California, United States
UCHealth Anschutz Inpatient Pavilion - Anschutz Medical Campus
Aurora, Colorado, United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
University of Colorado Clinical and Translational Research Center
Aurora, Colorado, United States
University of Colorado Hospital
Aurora, Colorado, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, United States
BRP- Hialeah Hospital
Hialeah, Florida, United States
D&H Cancer Research Center LLC
Margate, Florida, United States
Kendall South Medical Center
Miami, Florida, United States
Velocity Clinical Research, Savannah
Savannah, Georgia, United States
Humphreys Diabetes Center
Boise, Idaho, United States
St. Luke's Idaho Elks Children's Pavilion
Boise, Idaho, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
Jadestone Clinical Research
Silver Spring, Maryland, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States