A Study to Investigate Intravenous Tocilizumab in Participants With Moderate to Severe COVID-19 Pneumonia
NCT ID: NCT04363736
Last Updated: 2022-08-31
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
97 participants
INTERVENTIONAL
2020-05-05
2020-08-12
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
NONE
Study Groups
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TCZ 8 mg/kg
Participants will receive intravenous (IV) tocilizumab (TCZ) at a dose of 8 mg/kg in addition to standard-of-care treatment.
Tociliuzumab
Participants will receive IV TCZ.
TCZ 4 mg/kg
Participants will receive IV tocilizumab (TCZ) at a dose of 4 mg/kg in addition to standard-of-care treatment.
Tociliuzumab
Participants will receive IV TCZ.
Interventions
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Tociliuzumab
Participants will receive IV TCZ.
Eligibility Criteria
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Inclusion Criteria
* For severe patients, SpO2 \</= 93% or PaO2/FiO2 \< 300 mmHg. If a participant is on supplemental oxygen with SpO2 \> 93%, but desaturation \</= to 93% on lower supplemental oxygen or ambient air is documented during screening, the inclusion criterion is met
* For moderate patients (those who do not qualify as severe based oxygen requirements), CRP \> 2 x upper limit of normal (ULN) is required
* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, as defined by the protocol
* For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm, as defined by the protocol
Exclusion Criteria
* Active tuberculosis (TB) infection
* Suspected active bacterial, fungal, viral, or other infection (besides SARS-CoV-2)
* Participants who are on a mechanical ventilator \> 24 hours or extracorporeal membrane oxygenation (ECMO), in shock, or combination thereof with other organ failure requiring treatment in an ICU
* In the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments
* Receipt of oral anti-rejection or immunomodulatory drugs (including TCZ) within the past 3 months
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 10 x ULN detected within 24 hours at screening or at baseline (according to local laboratory reference ranges)
* Absolute neutrophil count (ANC) \< 1000/uL at screening and baseline (according to local laboratory reference ranges)
* Platelet count \< 50,000/uL at screening and baseline (according to local laboratory reference ranges)
* Pregnancy or breastfeeding, or positive pregnancy test at a predose examination
* Treatment with an investigational drug within 5 drug-elimination half-lives or 30 days (whichever is longer) of randomization
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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Mayo Clinic - Arizona
Phoenix, Arizona, United States
St. Jude Medical Center
Fullerton, California, United States
LAC + USC Medical Center
Los Angeles, California, United States
USC Keck Medical Center of USC
Los Angeles, California, United States
Norwalk Hospital
Norwalk, Connecticut, United States
Medstar Georgetown University Hospital
Washington D.C., District of Columbia, United States
Mayo Clinic
Jacksonville, Florida, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, United States
Advocate Lutheran General Hospital
Park Ridge, Illinois, United States
University of Maryland
Baltimore, Maryland, United States
Renown Institute for Heart & Vascular Health
Reno, Nevada, United States
St Joseph's Regional Medical Center
Wayne, New Jersey, United States
SUNY Downstate Medical Center.
Brooklyn, New York, United States
Jamaica Hospital Medical Center
Jamaica, New York, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Mercy St. Vincent Medical Center
Toledo, Ohio, United States
Lehigh Valley Health Network
Allentown, Pennsylvania, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
Allegheny Health Network (Pittsburg PA)
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Houston Methodist Hospital
Houston, Texas, United States
Michael E. DeBakey VA Medical Center
Houston, Texas, United States
Houston Methodist Sugar Land Hospital
Sugar Land, Texas, United States
Countries
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References
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Kumar PN, Hernandez-Sanchez J, Nagel S, Feng Y, Cai F, Rabin J, Morse CG, Nadig NR, Ashraf O, Gotur DB, McComsey GA, Gafoor K, Perin P, Thornton SC, Stubbings W, Lin CJF, Tsai L. Safety and Efficacy of Tocilizumab 4 or 8 mg/kg in Hospitalized Patients With Moderate to Severe Coronavirus Disease 2019 Pneumonia: A Randomized Clinical Trial. Open Forum Infect Dis. 2021 Dec 4;9(1):ofab608. doi: 10.1093/ofid/ofab608. eCollection 2022 Jan.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CA42481
Identifier Type: -
Identifier Source: org_study_id
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