A Study to Evaluate the Efficacy and Safety of Tocilizumab in Hospitalized Participants With COVID-19 Pneumonia
NCT ID: NCT04372186
Last Updated: 2023-02-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
377 participants
INTERVENTIONAL
2020-05-14
2020-09-22
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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Placebo
Participants will receive one intravenous (IV) infusion of placebo, in addition to SOC. Up to one additional infusion may be given.
Placebo
Participants will receive one dose of IV placebo matched to TCZ. Up to one additional dose may be given.
Tocilizumab
Participants will receive one IV infusion of TCZ in addition to SOC. Up to one additional infusion may be given.
Tocilizumab
Participants will receive one IV infusion of TCZ 8 mg/kg, with a maximum dose of 800 mg. Up to one additional dose may be given.
Interventions
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Placebo
Participants will receive one dose of IV placebo matched to TCZ. Up to one additional dose may be given.
Tocilizumab
Participants will receive one IV infusion of TCZ 8 mg/kg, with a maximum dose of 800 mg. Up to one additional dose may be given.
Eligibility Criteria
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Inclusion Criteria
* COVID-19 pneumonia confirmed by a positive polymerase chain reaction (PCR) of any specimen and radiographic imaging
* SpO2 \< 94% while on ambient air
* Participated in Study ML42528 (EMPACTA) (includes participants who completed or discontinued early from the main study)
Exclusion Criteria
* Require continuous positive airway pressure (CPAP), bilevel positive airway pressure (BIPAP), or invasive mechanical ventilation
* 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
* Immunocompromised (besides well-controlled HIV) or on immunosuppressive therapy (except for steroids for COVID), advanced cancer
* Have received oral anti-rejection or immunomodulatory drugs (including TCZ) within the past 3 months
* Participating in another interleukin (IL)-6 antagonist clinical trial or other drug clinical trials (participation in COVID-19 anti-viral trials may be permitted if approved by Medical Monitor)
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 10 x upper limit of normal (ULN) detected within 24 hours at screening (according to local laboratory reference ranges)
* Absolute neutrophil count (ANC) \< 1000/uL at screening (according to local laboratory reference ranges)
* Platelet count \< 50,000/uL at screening (according to local laboratory reference ranges)
* 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 Medical 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
* Any history of Diverticulitis or GI perforation
* Use of systemic corticosteroids unless on a stable chronic dose
18 Years
ALL
No
Sponsors
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Genentech, Inc.
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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Banner - University Medical Center Phoenix; In-Patient Pharmacy
Phoenix, Arizona, United States
Univ of AZ Coll of Med
Tucson, Arizona, United States
El Centro Regional Medical Center
El Centro, California, United States
eStudySite
La Mesa, California, United States
Highland Hospital Oakland
Oakland, California, United States
St. Joseph'S Hospital
Orange, California, United States
San Leandro Hospital; Inpatient Pharmacy
San Leandro, California, United States
Larkin Community Hospital Palm Springs Campus (Hialeah)
Hialeah, Florida, United States
Miami Veterans Administration Healthcare System - NAVREF
Miami, Florida, United States
University of Miami Pulmonary
Miami, Florida, United States
Larkin Community Hospital
South Miami, Florida, United States
St. Lukes Boise Medical Center
Boise, Idaho, United States
Ochsner Clinic
New Orleans, Louisiana, United States
Holy Cross Germantown Hospital
Germantown, Maryland, United States
Holy Cross Hospital
Silver Spring, Maryland, United States
Henry Ford Health System
Detroit, Michigan, United States
St. Joseph'S Regional Medical Center
Paterson, New Jersey, United States
San Juan Oncology Associates
Farmington, New Mexico, United States
SUNY Downstate Medical Center.
Brooklyn, New York, United States
Elmhurst Hospital Center
Elmhurst, New York, United States
Flushing Hospital
Flushing, New York, United States
Jamaica Hospital Medical Center
Jamaica, New York, United States
Harlem Hospital
New York, New York, United States
Canton-Potsdam Hospital
Potsdam, New York, United States
St. Barnabas Hospital
The Bronx, New York, United States
Novant Health Presbyterian Medical Center (Presbyterian Hospital)
Charlotte, North Carolina, United States
Cape Fear Valley Medical Center
Fayetteville, North Carolina, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
Valley Baptist Medical Center
Harlingen, Texas, United States
Michael E Debakey VA Medical Center
Houston, Texas, United States
McAllen Medical Center
McAllen, Texas, United States
Sentara Medical Group
Virginia Beach, Virginia, United States
Hospital E Maternidade Celso Pierro PUCCAMP
Campinas, São Paulo, Brazil
Centro Multidisciplinar de Estudos Clínicos CEMEC FMABC
São Bernardo do Campo, São Paulo, Brazil
BR Trials - Pesquisa Clínica
São Paulo, São Paulo, Brazil
Aga Khan University Hospital
Nairobi, , Kenya
Hospital General de Culiacan
Culiacán, , Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
México, , Mexico
Hospital Militar Central
Jesus Maria, , Peru
Hospital Nacional Sergio E. Bernales
Lima, , Peru
Hospital Nacional Cayetano Heredia
Lima, , Peru
Hospital Nacional Hipolito; Unanue
Lima, , Peru
Hospital Maria Auxiliadora
Lima, , Peru
George Provincial Hospital
George, , South Africa
Countries
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References
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Salama C, Han J, Yau L, Reiss WG, Kramer B, Neidhart JD, Criner GJ, Kaplan-Lewis E, Baden R, Pandit L, Cameron ML, Garcia-Diaz J, Chavez V, Mekebeb-Reuter M, Lima de Menezes F, Shah R, Gonzalez-Lara MF, Assman B, Freedman J, Mohan SV. Tocilizumab in Patients Hospitalized with Covid-19 Pneumonia. N Engl J Med. 2021 Jan 7;384(1):20-30. doi: 10.1056/NEJMoa2030340. Epub 2020 Dec 17.
Tleyjeh IM. The Misleading "Pooled Effect Estimate" of Crude Data from Observational Studies at Critical Risk of Bias: The Case of Tocilizumab in Coronavirus Disease 2019 (COVID-19). Clin Infect Dis. 2021 Jun 15;72(12):e1154-e1155. doi: 10.1093/cid/ciaa1735. No abstract available.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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ML42528
Identifier Type: -
Identifier Source: org_study_id
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