A Study to Evaluate the Safety and Efficacy of Tocilizumab in Patients With Severe COVID-19 Pneumonia

Part of paid clinical trials in La Jolla, California.

Sponsor
Hoffmann-La Roche
Study ID
NCT04320615
Phase
PHASE3
Status
Completed

Conditions

  • COVID-19 Pneumonia

Eligibility Criteria

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

Interventions

  • Tocilizumab (TCZ) — DRUG
    Participants will receive 1 dose of IV TCZ. 1 additional dose may be given if clinical symptoms worsen or show no improvement.
  • Placebo — DRUG
    Participants will receive 1 dose of IV placebo matched to TCZ. Up to 1 additional dose may be given if clinical symptoms worsen or show no improvement.

Study Details

This study will evaluate the efficacy, safety, pharmacodynamics, and pharmacokinetics of tocilizumab (TCZ) compared with a matching placebo in combination with standard of care (SOC) in hospitalized patients with severe COVID-19 pneumonia.

Key Dates

Start date
Apr 3, 2020
Status verified
Jun 2021
Primary completion
Jun 24, 2020
Completion
Jul 28, 2020

Study Design

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

Arms

  • Experimental: Tocilizumab (TCZ) Arm
    Participants will receive 1 intravenous (IV) infusion of TCZ, dosed at 8 mg/kg, up to a maximum dose 800 mg. Up to 1 additional dose may be given if clinical symptoms worsen or show no improvement.
  • Placebo Comparator: Placebo Arm
    Participants will receive 1 IV infusion of placebo matched to TCZ. Up to 1 additional dose may be given if clinical symptoms worsen or show no improvement.

Primary Outcome Measure

Clinical Status Assessed Using a 7-Category Ordinal Scale at Day 28 (Week 4) [ Time Frame: Day 28 ]

Locations (23)

FacilityCityStateZIPSite coordinators
University of California San DiegoLa JollaCalifornia92093-
eStudySiteLa MesaCalifornia91942-
David Geffen School of Medicine UCLALos AngelesCalifornia90095-
Stanford UniversityStanfordCalifornia94305-
Denver Health Medical CenterDenverColorado80204-
University of Miami Miller School of MedicineMiamiFlorida33136-
Rush University Medical CenterChicagoIllinois60612-
University of ChicagoChicagoIllinois60637-
Ochsner Clinic FoundationBaton RougeLouisiana70809-
Baystate Health SystemSpringfieldMassachusetts01199-
Mayo Clinic - PPDSRochesterMinnesota55905-
Hackensack University Medical CenterHackensackNew Jersey07601-
Robert Wood Johnson University Hospital/RutgersNew BrunswickNew Jersey08901-
James J Peters Veterans Administration Medical Center - NAVREFThe BronxNew York10468-
Duke University Medical CenterDurhamNorth Carolina27710-
Cleveland Clinic Foundation; Pulmonary, Allergy & Critical Care MedicineClevelandOhio44195-
Thomas Jefferson UniversityPhiladelphiaPennsylvania19107-
Baylor St. Luke's Medical CenterHoustonTexas77030-
Ben Taub General Hospital - HCHDHoustonTexas77030-
Intermountain LDS HospitalSalt Lake CityUtah84143-
Intermountain Medical GroupSt. GeorgeUtah84770-
Evergreen Health Infectious DiseaseKirklandWashington98034-
Swedish Hospital Medical CenterSeattleWashington98104-

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By research site
University of California San Diego· La Jolla, CAeStudySite· La Mesa, CADavid Geffen School of Medicine UCLA· Los Angeles, CAStanford University· Stanford, CADenver Health Medical Center· Denver, COUniversity of Miami Miller School of Medicine· Miami, FL

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