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
NCT ID: NCT04409262
Last Updated: 2022-02-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
649 participants
INTERVENTIONAL
2020-06-16
2021-03-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
Remdesivir
Participants will receive intravenous (IV) RDV
Tocilizumab
Participants will receive IV TCZ
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.
Remdesivir
Participants will receive intravenous (IV) RDV
Placebo
Participants will receive IV placebo matched to TCZ
Interventions
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Remdesivir
Participants will receive intravenous (IV) RDV
Tocilizumab
Participants will receive IV TCZ
Placebo
Participants will receive IV placebo matched to TCZ
Eligibility Criteria
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Inclusion Criteria
* Requiring more than 6 L/min supplemental oxygen to maintain SpO2 \> 93%
* Agrees to not participate in another clinical trial for the treatment of COVID-19 while participating in this study
Exclusion Criteria
* Known hypersensitivity to remdesivir, the metabolites, or formulation excipients
* Active tuberculosis (TB) infection
* Suspected active bacterial, fungal, viral, or other infection (besides COVID-19)
* In the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments
* Treatment with immunosuppressive or immunomodulatory therapy (including tocilizumab) within the past 3 months
* Concurrent treatment with other agents with actual or possible direct-acting antiviral activity against SARS-CoV-2 within 24 hours prior to study drug dosing. In addition, participants with prior or current treatment with \> 2 doses of remdesivir for COVID-19 are excluded
* Participating in other drug clinical trials
* Estimated glomerular filtration rate (eGFR) \< 30 mL/min (including patients receiving hemodialysis or hemofiltration)
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 5 x upper limit of normal (ULN) detected within 24 hours of screening (according to local laboratory reference ranges)
* Absolute neutrophil count (ANC) \< 1000/uL at screening
* Platelet count \< 50,000/uL at screening
* Body weight \< 40 kg
* Treatment with an investigational drug within 5 half-lives or 30 days (whichever is longer) of randomization
12 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Valleywise Health Medical Center
Phoenix, Arizona, United States
eStudySite - Chula Vista - PPDS
Chula Vista, California, United States
Hoag Hospital Irvine
Irvine, California, United States
Providence St Johns Health Center
Santa Monica, California, United States
Yale University School of Medicine; HIV Clinical Trials Program
New Haven, Connecticut, United States
Medstar Georgetown University Hospital
Washington D.C., District of Columbia, United States
Holy Cross Hospital Inc
Fort Lauderdale, Florida, United States
Larkin Community Hospital Palm Springs Campus (Hialeah)
Hialeah, Florida, United States
University of Miami Miller School of Medicine; Clinical Reseach Building
Miami, Florida, United States
Larkin Community Hospital
South Miami, Florida, United States
St Luke's Health System; Rheumatology Research
Boise, Idaho, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
University of Maryland
Baltimore, Maryland, United States
Boston Medical Center
Boston, Massachusetts, United States
Baystate Medical Center
Springfield, Massachusetts, United States
Henry Ford Medical Center
Novi, Michigan, United States
St. Michael'S Medical Center
Newark, New Jersey, United States
San Juan Oncology Associates
Farmington, New Mexico, United States
Wyckoff Heights Medical Center
Staten Island, New York, United States
Novant Health Clinical Research
Charlotte, North Carolina, United States
OhioHealth Research Institute
Columbus, Ohio, United States
Providence Saint Vincent's Medical Center
Portland, Oregon, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
The Liver Institute at Methodist Dallas
Arlington, Texas, United States
Baylor Scott and White Medical Center - College Station
College Station, Texas, United States
Baylor University Medical Center
Dallas, Texas, United States
Baylor St. Luke's Medical Center
Houston, Texas, United States
Ben Taub General Hospital - HCHD
Houston, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
Baylor Scott & White Medical Center - Irving
Irving, Texas, United States
Baylor Scott & White Hospital - Plano
Plano, Texas, United States
Baylor Scott & White Health
Temple, Texas, United States
Intermountain LDS Hospital
Salt Lake City, Utah, United States
The Providence Regional Medical Center Everett
Everett, Washington, United States
West Virginia University Hospital
Morgantown, West Virginia, United States
Santa Casa de Misericordia de Belo Horizonte
Belo Horizonte, Minas Gerais, Brazil
Hospital Nossa Senhora das Graças; Setor de Pesquisa em Neurologia
Curitiba, Paraná, Brazil
Instituto de Pesquisa Clinica Evandro Chagas - IPEC FIOCRUZ
Rio de Janeiro, Rio de Janeiro, Brazil
CEMEC - Centro Multidisciplinar de Estudos Clínicos
São Bernardo do Campo, São Paulo, Brazil
Hospital de Base de Sao Jose do Rio Preto
São José do Rio Preto, São Paulo, Brazil
Instituto de Infectologia Emilio Ribas
São Paulo, São Paulo, Brazil
Instituto do Coração - HCFMUSP
São Paulo, São Paulo, Brazil
Medsi Clinic
Moscow, Adygeya Republic, Russia
O.M. Filatov City Clinical Hospital #15; Department of Surgery
Moskva, Moscow Oblast, Russia
City Pokrovskaya Hospital
Saint Petersburg, Sankt-Peterburg, Russia
City Clinical Hospital # 52
Moscow, , Russia
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario Principe de Asturias; Medicina Interna - Servicio de Enfermedades Infecciosas
Alcalá de Henares, Madrid, Spain
Hospital Universitario HM Torrelodones
Torrelodones, Madrid, Spain
Hospital General Universitario de Guadalajara
Guadalajara, , Spain
Hospital Universitario Fundacion Jimenez Diaz.
Madrid, , Spain
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2020-002275-34
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
WA42511
Identifier Type: -
Identifier Source: org_study_id
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