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

Part of paid clinical trials in Canoga Park, California.

Sponsor
Pfizer
Study ID
NCT07013474
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • COVID-19 Infection

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ibuzatrelvir — DRUG
    tablet
  • remdesivir — DRUG
    injection, for intravenous use
  • placebo for ibuzatrelvir — DRUG
    tablet
  • placebo for remdesivir — DRUG
    injection, for intravenous use

Study Details

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.

Key Dates

Start date
Jul 14, 2025
Status verified
Jun 2026
Primary completion
Sep 27, 2027
Completion
Feb 25, 2028

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ibuzatrelvir
    Participants will receive ibuzatrelvir orally twice a day + IV placebo for remdesivir
  • Experimental: Ibuzatrelvir + Remdesivir
    Participants will receive ibuzatrelvir orally twice a day + IV remdesivir
  • Experimental: Remdesivir
    Participants will receive placebo for ibuzatrelvir orally twice a day + IV remdesivir

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

Locations (60)

FacilityCityStateZIPSite coordinators
Hope Clinical Research, Inc.Canoga ParkCalifornia91303-
Amicis Research Center - Granada HillsGranada HillsCalifornia91344-
Jacobs Medical Center at UC San Diego HealthLa JollaCalifornia92037-
UC Davis CTSC Clinical Research CenterSacramentoCalifornia95817-
University of California Davis HealthSacramentoCalifornia95817-
UC San Diego Medical Center - HillcrestSan DiegoCalifornia92103-
University of California San Diego HealthSan DiegoCalifornia92103-
UCHealth Anschutz Inpatient Pavilion - Anschutz Medical CampusAuroraColorado80045-
University of Colorado Anschutz Medical CampusAuroraColorado80045-
University of Colorado Clinical and Translational Research CenterAuroraColorado80045-
University of Colorado HospitalAuroraColorado80045-
Georgetown University Medical CenterWashington D.C.District of Columbia20007-
BRP- Hialeah HospitalHialeahFlorida33013-
D&H Cancer Research Center LLCMargateFlorida33063-
Kendall South Medical CenterMiamiFlorida33185-
Velocity Clinical Research, SavannahSavannahGeorgia31406-
Humphreys Diabetes CenterBoiseIdaho83702-
St. Luke's Idaho Elks Children's PavilionBoiseIdaho83712-
Northwestern Memorial HospitalChicagoIllinois60611-
Northwestern University Feinberg School of MedicineChicagoIllinois60611-
Johns Hopkins HospitalBaltimoreMaryland21287-
Jadestone Clinical ResearchSilver SpringMaryland20904-
Brigham and Women's HospitalBostonMassachusetts02115-
Clinical Trials CenterBostonMassachusetts02115-
Clinical Trials HubBostonMassachusetts02115-
Skylight Health Research, - BurlingtonBurlingtonMassachusetts01803-
University of Massachusetts Chan Medical SchoolWorcesterMassachusetts01655-
University of MichiganAnn ArborMichigan48109-
Henry Ford HospitalDetroitMichigan48202-
Profound Research LLCFarmington HillsMichigan48334-
Revive Research Institute, Inc.Farmington HillsMichigan48334-
Holy Name Medical CenterTeaneckNew Jersey07666-
Duke University - Main Hospital and ClinicsDurhamNorth Carolina27710-
Duke Vaccine and Trials UnitDurhamNorth Carolina27703-
Duke Vaccine and Trials UnitDurhamNorth Carolina27705-
University of Cincinnati College of Medicine (UC Holmes)CincinnatiOhio45267-
University of Cincinnati Medical CenterCincinnatiOhio45219-
TRCPittsburghPennsylvania15213-
University of Pittsburgh Medical CenterPittsburghPennsylvania15213-
UPMC Division of Infectious Disease ClinicPittsburghPennsylvania15213-
UPMC Hillman Cancer CenterPittsburghPennsylvania15232-
UPMC Presbyterian IDSPittsburghPennsylvania15213-
UPMC Presbyterian ShadysidePittsburghPennsylvania15213-
UPMC ShadysidePittsburghPennsylvania15232-
UPMC Shadyside IDSPittsburghPennsylvania15232-
West Tennessee Research InstituteJacksonTennessee38305-
Baylor Scott & White Health - Center for Advanced Heart and Lung DiseaseDallasTexas75246-
Baylor Scott & White Research Institute - Clinical Trials OfficeDallasTexas75246-
Baylor University Medical CenterDallasTexas75246-
Zenos Clinical ResearchDallasTexas75230-
Houston Methodist HospitalHoustonTexas77030-
Memorial Hermann HospitalHoustonTexas77030-
The University of Texas Health Science Center at HoustonHoustonTexas77030-
UT PhysiciansHoustonTexas77030-
Seattle Rheumatology AssociatesSeattleWashington98104-
Swedish Ambulatory Infusion Center- First HillSeattleWashington98104-
Swedish Cancer Institute Treatment CenterSeattleWashington98104-
Swedish Medical Center - First Hill CampusSeattleWashington98122-
Swedish Medical Center- Innovative Therapeutics & Research UnitSeattleWashington98104-
Swedish Organ Transplant and Liver CenterSeattleWashington98104-

Find similar trials in Canoga Park, CA

By research site
Hope Clinical Research, Inc.· Canoga Park, CAAmicis Research Center - Granada Hills· Granada Hills, CAJacobs Medical Center at UC San Diego Health· La Jolla, CAUC Davis CTSC Clinical Research Center· Sacramento, CAUniversity of California Davis Health· Sacramento, CAUC San Diego Medical Center - Hillcrest· San Diego, CA

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