drugset / Trial / NCT04380519
Study of the Efficacy and Safety of a Single Administration of Olokizumab and RPH-104 With Standard Therapy in Patients With Severe Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection (COVID-19)
Phase 2/3
Completed
372 enrolled
R-Pharm International, LLC
Data Management 365 · collabK-Research, LLC · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
The primary objective of the study was to evaluate the efficacy and safety of a single dose of RPH-104 (80 mg) or OKZ (64 mg) compared to placebo in addition to standard therapy in patients with severe SARS-CoV-2 infection (COVID-19) at Day 15 of the study.
Timeline
- Start
- 2020-04-23
- Primary completion
- 2020-07-10
- Completion
- 2020-07-24
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Goflikicept | Monoclonal antibody | 80 mg | Subcutaneous |
| Subject | Olokizumab | Monoclonal antibody | 64 mg | Subcutaneous |