Trials / Completed
CompletedNCT04397562
A Clinical Trial of the Efficacy and Safety of Levilimab (BCD-089) in Patients With Severe COVID-19
A Multicenter, Randomized, Double-blind, Placebo-controlled, Adaptively Designed Clinical Trial of the Efficacy and Safety of Levilimab (BCD-089) in Patients With Severe COVID-19
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 206 (actual)
- Sponsor
- Biocad · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The objective: to study the efficacy and safety of levilimab in subjects with severe COVID-19.
Detailed description
This study is multicenter, comparative, randomized, double-blind, placebo controlled clinical trial with adaptive design. Females and males, aged 18 years and older, admitted to hospital with severe COVID-19 pneumonia on SOC therapy will receive either levilimab 324 mg s/c or placebo s/c. In case of no clinical improvement is observed, investigator can administer a rescue therapy - open label LVL 324 mg s/c. The outcomes will be assessed up to day 60. Results of interim analysis of safety and efficacy data of first 60 enrolled subjects will be submitted for independent DMC review and decision about changes to the protocol.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Levilimab | Levilimab 324 mg |
| DRUG | Placebo | Placebo |
Timeline
- Start date
- 2020-04-29
- Primary completion
- 2020-07-03
- Completion
- 2020-08-03
- First posted
- 2020-05-21
- Last updated
- 2021-11-18
Locations
16 sites across 1 country: Russia
Source: ClinicalTrials.gov record NCT04397562. Inclusion in this directory is not an endorsement.