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A Study to Evaluate the Safety and Efficacy of Tocilizumab in Patients With Severe COVID-19 Pneumonia
- Infectious Diseases
- COVID-19 Pneumonia
Please note that the recruitment status of the trial at your site may differ.
Trial Status:
Completed
This trial runs in
Cities
- Barcelona
- Baton Rouge
- Breda
- Chicago
- Cleveland
- Denver
- Durham
- Düsseldorf
- Glasgow
- Hackensack
- Hamilton
- Hannover
- Houston
- Hvidovre
- Kirkland
- Köln
- København
- L'Hospitalet de Llobregat
- La Jolla
- La Roche-sur-Yon
- Leeds
- Limoges
- London
- Los Angeles
- Lyon
- Madrid
- Manchester
- Miami
- Montréal
- Monza
- München
- Nantes
- New Brunswick
- New York
- Nieuwegein
- Odense
- Paris
- Pavia
- Philadelphia
- Rochester
- Roskilde
- Rotterdam
- Salt Lake City
- San Diego
- Seattle
- Springfield
- St. George
- Stanford
- Toronto
- Tours
- Utrecht
Trial Identifier:
NCT04320615 2020-001154-22 WA42380
Trial Summary
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.
Hoffmann-La Roche
Sponsor
Phase 3
Phase
NCT04320615,WA42380,2020-001154-22
Trial Identifier
Tocilizumab (TCZ), Placebo
Treatments
COVID-19 Pneumonia
Condition
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Tocilizumab in Patients With Severe COVID-19 Pneumonia
Eligibility Criteria
All
Gender
≥18 Years
Age
No
Healthy Volunteers
Inclusion Criteria
- Hospitalized with COVID-19 pneumonia confirmed per WHO criteria (including a positive PCR of any specimen; e.g., respiratory, blood, urine, stool, other bodily fluid) and evidenced by chest X-ray or CT scan
- SPO2 </=93% or PaO2/FiO2 <300 mmHg
Exclusion Criteria
- Known severe allergic reactions to TCZ or other monoclonal antibodies
- 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)
For the latest version of this information please go to www.forpatients.roche.com