A Study to Evaluate the Efficacy and Safety of Remdesivir Plus Tocilizumab Compared With Remdesivir Plus Placebo in Hospitalized Participants With Severe COVID-19 Pneumonia

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Hoffmann-La Roche
Study ID
NCT04409262
Phase
PHASE3
Status
Completed

Conditions

  • COVID-19 Pneumonia

Eligibility Criteria

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

Interventions

  • Remdesivir — DRUG
    Participants will receive intravenous (IV) RDV
  • Tocilizumab — DRUG
    Participants will receive IV TCZ
  • Placebo — DRUG
    Participants will receive IV placebo matched to TCZ

Study Details

This study will evaluate the efficacy and safety of combination therapy with remdesivir plus tocilizumab compared with remdesivir plus placebo in hospitalized patients with COVID-19 pneumonia.

Key Dates

Start date
Jun 16, 2020
Status verified
Jan 2022
Primary completion
Feb 1, 2021
Completion
Mar 8, 2021

Study Design

Enrollment
649 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Remdesivir + Tocilizumab (RDV+TCZ)
    Participants assigned to the RDV+TCZ arm will receive a 10-day treatment course of RDV, plus one infusion of TCZ on Day 1.
  • Active Comparator: Remdesivir + Placebo (RDV+Placebo)
    Participants assigned to the RDV+ placebo arm will receive a 10-day treatment course of RDV, plus one infusion of TCZ-placebo on Day 1.

Primary Outcome Measure

Time to Hospital Discharge or "Ready for Discharge" up to Day 28 [ Time Frame: Up to Day 28 ]

Locations (38)

FacilityCityStateZIPSite coordinators
Valleywise Health Medical CenterPhoenixArizona85008-
eStudySite - Chula Vista - PPDSChula VistaCalifornia91911-
Hoag Hospital IrvineIrvineCalifornia92612-
Providence St Johns Health CenterSanta MonicaCalifornia90404-
Yale University School of Medicine; HIV Clinical Trials ProgramNew HavenConnecticut06501-
Medstar Georgetown University HospitalWashington D.C.District of Columbia20007-
Holy Cross Hospital IncFort LauderdaleFlorida33308-
Larkin Community Hospital Palm Springs Campus (Hialeah)HialeahFlorida33012-
University of Miami Miller School of Medicine; Clinical Reseach BuildingMiamiFlorida33136-
Larkin Community HospitalSouth MiamiFlorida33143-
St Luke's Health System; Rheumatology ResearchBoiseIdaho83702-
Advocate Christ Medical CenterOak LawnIllinois60453-
Ochsner Clinic FoundationNew OrleansLouisiana70121-
University of MarylandBaltimoreMaryland21201-
Boston Medical CenterBostonMassachusetts02118-2393-
Baystate Medical CenterSpringfieldMassachusetts01199-
Henry Ford Medical CenterNoviMichigan48322-
St. Michael'S Medical CenterNewarkNew Jersey07102-
San Juan Oncology AssociatesFarmingtonNew Mexico87401-
Wyckoff Heights Medical CenterStaten IslandNew York11237-
Novant Health Clinical ResearchCharlotteNorth Carolina28204-
OhioHealth Research InstituteColumbusOhio43214-
Providence Saint Vincent's Medical CenterPortlandOregon97225-
Lehigh Valley HospitalAllentownPennsylvania18103-
Thomas Jefferson UniversityPhiladelphiaPennsylvania19107-
Medical University of South CarolinaCharlestonSouth Carolina29425-
The Liver Institute at Methodist DallasArlingtonTexas76012-
Baylor Scott and White Medical Center - College StationCollege StationTexas77845-
Baylor University Medical CenterDallasTexas75231-
Baylor St. Luke's Medical CenterHoustonTexas77030-
Ben Taub General Hospital - HCHDHoustonTexas77030-
Houston Methodist HospitalHoustonTexas77030-
Baylor Scott & White Medical Center - IrvingIrvingTexas75061-
Baylor Scott & White Hospital - PlanoPlanoTexas75093-
Baylor Scott & White HealthTempleTexas76502-
Intermountain LDS HospitalSalt Lake CityUtah84143-
The Providence Regional Medical Center EverettEverettWashington98201-
West Virginia University HospitalMorgantownWest Virginia26506-

Find similar trials in Phoenix, AZ

By research site
Valleywise Health Medical Center· Phoenix, AZeStudySite - Chula Vista - PPDS· Chula Vista, CAHoag Hospital Irvine· Irvine, CAProvidence St Johns Health Center· Santa Monica, CAYale University School of Medicine; HIV Clinical Trials Program· New Haven, CTMedstar Georgetown University Hospital· Washington D.C., DC

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