ibuzatrelvirremdesivirplacebo for ibuzatrelvirplacebo for remdesivir
ibuzatrelvir: tablet
remdesivir: injection, for intravenous use
placebo for ibuzatrelvir: tablet
placebo for remdesivir: injection, for intravenous use
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
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 — 38 days The difference in the proportion of participants with the composite endpoint of a) Progression to severe COVID-19 or all-cause mortality by Day 38, or b) Evidence of recurrent or persistent SARS-CoV-2 infection
Trial sites (152)
Facility
City
Region
Status
Hope Clinical Research, Inc.
Canoga Park
California
Recruiting
Amicis Research Center - Granada Hills
Granada Hills
California
Recruiting
Jacobs Medical Center at UC San Diego Health
La Jolla
California
Recruiting
UC Davis CTSC Clinical Research Center
Sacramento
California
Recruiting
University of California Davis Health
Sacramento
California
Recruiting
UC San Diego Medical Center - Hillcrest
San Diego
California
Recruiting
University of California San Diego Health
San Diego
California
Recruiting
UCHealth Anschutz Inpatient Pavilion - Anschutz Medical Campus
Aurora
Colorado
Recruiting
University of Colorado Anschutz Medical Campus
Aurora
Colorado
Recruiting
University of Colorado Clinical and Translational Research Center
Aurora
Colorado
Recruiting
University of Colorado Hospital
Aurora
Colorado
Recruiting
Georgetown University Medical Center
Washington D.C.
District of Columbia
Recruiting
BRP- Hialeah Hospital
Hialeah
Florida
Recruiting
D&H Cancer Research Center LLC
Margate
Florida
Recruiting
Kendall South Medical Center
Miami
Florida
Recruiting
Velocity Clinical Research, Savannah
Savannah
Georgia
Recruiting
Humphreys Diabetes Center
Boise
Idaho
Recruiting
St. Luke's Idaho Elks Children's Pavilion
Boise
Idaho
Recruiting
Northwestern Memorial Hospital
Chicago
Illinois
Recruiting
Northwestern University Feinberg School of Medicine
Chicago
Illinois
Recruiting
Johns Hopkins Hospital
Baltimore
Maryland
Recruiting
Jadestone Clinical Research
Silver Spring
Maryland
Recruiting
Brigham and Women's Hospital
Boston
Massachusetts
Recruiting
Clinical Trials Center
Boston
Massachusetts
Recruiting
Clinical Trials Hub
Boston
Massachusetts
Recruiting
University of Massachusetts Chan Medical School
Worcester
Massachusetts
Recruiting
University of Michigan
Ann Arbor
Michigan
Recruiting
Henry Ford Hospital
Detroit
Michigan
Recruiting
Holy Name Medical Center
Teaneck
New Jersey
Recruiting
Duke Vaccine and Trials Unit
Durham
North Carolina
Recruiting
Duke Vaccine and Trials Unit
Durham
North Carolina
Recruiting
Duke University - Main Hospital and Clinics
Durham
North Carolina
Recruiting
University of Cincinnati Medical Center
Cincinnati
Ohio
Recruiting
University of Cincinnati College of Medicine (UC Holmes)
Cincinnati
Ohio
Recruiting
TRC
Pittsburgh
Pennsylvania
Recruiting
University of Pittsburgh Medical Center
Pittsburgh
Pennsylvania
Recruiting
UPMC Division of Infectious Disease Clinic
Pittsburgh
Pennsylvania
Recruiting
UPMC Presbyterian IDS
Pittsburgh
Pennsylvania
Recruiting
UPMC Presbyterian Shadyside
Pittsburgh
Pennsylvania
Recruiting
UPMC Hillman Cancer Center
Pittsburgh
Pennsylvania
Recruiting
+ 112 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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