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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 from the overall study status because some study sites may recruit earlier than others.
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