A Study to Evaluate the Safety and Efficacy of Tocilizumab in Patients With Severe COVID-19 Pneumonia
NCT ID: NCT04320615
Last Updated: 2021-06-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
452 participants
INTERVENTIONAL
2020-04-03
2020-07-28
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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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.
Tocilizumab (TCZ)
Participants will receive 1 dose of IV TCZ. 1 additional dose may be given if clinical symptoms worsen or show no improvement.
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.
Placebo
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.
Interventions
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Tocilizumab (TCZ)
Participants will receive 1 dose of IV TCZ. 1 additional dose may be given if clinical symptoms worsen or show no improvement.
Placebo
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.
Eligibility Criteria
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Inclusion Criteria
* SPO2 \</=93% or PaO2/FiO2 \<300 mmHg
Exclusion Criteria
* 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
* Have received oral anti-rejection or immunomodulatory drugs (including TCZ) with the past 3 months
* Participating in other drug clinical trials (participation in COVID-19 anti-viral trials may be permitted if approved by Medical Monitor)
* Pregnant or breastfeeding, or positive pregnancy test in a pre-dose examination
* Treatment with an investigational drug within 5 half-lives or 30 days (whichever is longer) of randomization (investigational COVID-19 antivirals may be permitted if approved by Medial Monitor)
* Any serious medical condition or abnormality of clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 10 x upper limit of normal (ULN) detected within 24 hours at screening (per local lab)
* Absolute neutrophil count (ANC) \< 1000/mL at screening (per local lab)
* Platelet count \< 50,000/mL at screening (per local lab)
18 Years
ALL
No
Sponsors
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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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University of California San Diego
La Jolla, California, United States
eStudySite
La Mesa, California, United States
David Geffen School of Medicine UCLA
Los Angeles, California, United States
Stanford University
Stanford, California, United States
Denver Health Medical Center
Denver, Colorado, United States
University of Miami Miller School of Medicine
Miami, Florida, United States
Rush University Medical Center
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
Ochsner Clinic Foundation
Baton Rouge, Louisiana, United States
Baystate Health System
Springfield, Massachusetts, United States
Mayo Clinic - PPDS
Rochester, Minnesota, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Robert Wood Johnson University Hospital/Rutgers
New Brunswick, New Jersey, United States
James J Peters Veterans Administration Medical Center - NAVREF
The Bronx, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Cleveland Clinic Foundation; Pulmonary, Allergy & Critical Care Medicine
Cleveland, Ohio, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Baylor St. Luke's Medical Center
Houston, Texas, United States
Ben Taub General Hospital - HCHD
Houston, Texas, United States
Intermountain LDS Hospital
Salt Lake City, Utah, United States
Intermountain Medical Group
St. George, Utah, United States
Evergreen Health Infectious Disease
Kirkland, Washington, United States
Swedish Hospital Medical Center
Seattle, Washington, United States
Hamilton General Hospital; Pharmacy
Hamilton, Ontario, Canada
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada
University Health Network
Toronto, Ontario, Canada
Clinical Research Institute of Montreal
Montreal, Quebec, Canada
Rigshospitalet Copenhagen University Hospital
Copenhagen, , Denmark
Hvidovre Hospital
Hvidovre, , Denmark
Odense Universitetshospital
Odense C, , Denmark
Sjællands Universitetshospital, Roskilde
Roskilde, , Denmark
Centre Hospitalier Departemental de Vendee
La Roche-sur-Yon, , France
Centre Hospitalier et Universitaire de Limoges
Limoges, , France
Hôpital de La Croix Rousse
Lyon, , France
Hotel Dieu - Nantes
Nantes, , France
Hopital de la Pitie Salpetriere
Paris, , France
HOPITAL COCHIN university hospital
Paris, , France
CHRU de Tours, Pharmacie
Tours, , France
Universitätsklinikum Köln; Innere Medizin I; Onkologie, Hämatologie
Cologne, , Germany
Universitatsklinikum Dusseldorf
Düsseldorf, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
LMU Klinikum der Universitat Munchen
München, , Germany
Azienda Ospedaliera San Gerardo di Monza
Monza MI, Lombardy, Italy
Fondazione IRCCS Policlinico San Matteo di Pavia; S.S. Fisiopatologia Respiratoria
Pavia, Lombardy, Italy
Amphia Ziekenhuis
Breda, , Netherlands
St. Antonius Ziekenhuis Nieuwegein
Nieuwegein, , Netherlands
Erasmus MC
Rotterdam, , Netherlands
Universitair Medisch Centrum Utrecht
Utrecht, , Netherlands
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Universitario Ramon y Cajal
Madrid, , Spain
Hospital General Universitario Gregorio Maranon
Madrid, , Spain
Hospital Universitario HM Sanchinarro-CIOCC
Madrid, , Spain
Greater Glasgow and Clyde Health Board
Glasgow, , United Kingdom
Leeds Teaching Hospitals NHS Trust
Leeds, , United Kingdom
University College Hospital
London, , United Kingdom
Royal Free Hospital
London, , United Kingdom
St George's Clinical Research Facility
London, , United Kingdom
Imperial College London
London, , United Kingdom
North Manchester General Hospital
Manchester, , United Kingdom
Countries
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References
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Rosas IO, Brau N, Waters M, Go RC, Malhotra A, Hunter BD, Bhagani S, Skiest D, Savic S, Douglas IS, Garcia-Diaz J, Aziz MS, Cooper N, Youngstein T, Sorbo LD, Zerda DJ, Ustianowski A, Gracian AC, Blyth KG, Carratala J, Francois B, Benfield T, Haslem D, Bonfanti P, van der Leest CH, Rohatgi N, Wiese L, Luyt CE, Bauer RN, Cai F, Lee IT, Matharu B, Metcalf L, Wildum S, Graham E, Tsai L, Bao M. Tocilizumab in patients hospitalised with COVID-19 pneumonia: Efficacy, safety, viral clearance, and antibody response from a randomised controlled trial (COVACTA). EClinicalMedicine. 2022 May;47:101409. doi: 10.1016/j.eclinm.2022.101409. Epub 2022 Apr 21.
Tom J, Bao M, Tsai L, Qamra A, Summers D, Carrasco-Triguero M, McBride J, Rosenberger CM, Lin CJF, Stubbings W, Blyth KG, Carratala J, Francois B, Benfield T, Haslem D, Bonfanti P, van der Leest CH, Rohatgi N, Wiese L, Luyt CE, Kheradmand F, Rosas IO, Cai F. Prognostic and Predictive Biomarkers in Patients With Coronavirus Disease 2019 Treated With Tocilizumab in a Randomized Controlled Trial. Crit Care Med. 2022 Mar 1;50(3):398-409. doi: 10.1097/CCM.0000000000005229.
Rosas IO, Brau N, Waters M, Go RC, Hunter BD, Bhagani S, Skiest D, Aziz MS, Cooper N, Douglas IS, Savic S, Youngstein T, Del Sorbo L, Cubillo Gracian A, De La Zerda DJ, Ustianowski A, Bao M, Dimonaco S, Graham E, Matharu B, Spotswood H, Tsai L, Malhotra A. Tocilizumab in Hospitalized Patients with Severe Covid-19 Pneumonia. N Engl J Med. 2021 Apr 22;384(16):1503-1516. doi: 10.1056/NEJMoa2028700. Epub 2021 Feb 25.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2020-001154-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
WA42380
Identifier Type: -
Identifier Source: org_study_id
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