Trials / Completed
CompletedNCT04320615
A Study to Evaluate the Safety and Efficacy of Tocilizumab in Patients With Severe COVID-19 Pneumonia
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Tocilizumab in Patients With Severe COVID-19 Pneumonia
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 452 (actual)
- Sponsor
- Hoffmann-La Roche · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tocilizumab (TCZ) | Participants will receive 1 dose of IV TCZ. 1 additional dose may be given if clinical symptoms worsen or show no improvement. |
| DRUG | 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. |
Timeline
- Start date
- 2020-04-03
- Primary completion
- 2020-06-24
- Completion
- 2020-07-28
- First posted
- 2020-03-25
- Last updated
- 2021-06-30
- Results posted
- 2021-06-30
Locations
62 sites across 9 countries: United States, Canada, Denmark, France, Germany, Italy, Netherlands, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04320615. Inclusion in this directory is not an endorsement.