Trials / Completed
CompletedNCT04372186
A Study to Evaluate the Efficacy and Safety of Tocilizumab in Hospitalized Participants With COVID-19 Pneumonia
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Tocilizumab in Hospitalized Patients With COVID-19 Pneumonia
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 377 (actual)
- Sponsor
- Genentech, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study (EMPACTA) will a) evaluate the efficacy and safety of tocilizumab (TCZ) compared with a placebo in combination with standard of care (SOC) in hospitalized participants with COVID-19 pneumonia, and b) include an optional long-term extension for eligible participants to explore the long-term sequelae of resolved COVID-19 pneumonia.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Placebo | Participants will receive one dose of IV placebo matched to TCZ. Up to one additional dose may be given. |
| DRUG | 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. |
Timeline
- Start date
- 2020-05-14
- Primary completion
- 2020-08-18
- Completion
- 2020-09-22
- First posted
- 2020-05-01
- Last updated
- 2023-02-10
- Results posted
- 2021-09-27
Locations
44 sites across 6 countries: United States, Brazil, Kenya, Mexico, Peru, South Africa
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04372186. Inclusion in this directory is not an endorsement.