Investigating Otilimab in Patients With Severe Pulmonary COVID-19 Related Disease
Summary
OSCAR (Otilimab in Severe COVID-19 Related Disease) is a multi-center, double-blind, randomized, placebo-controlled trial to assess the efficacy and safety of otilimab for the treatment of severe pulmonary COVID-19 related disease. The study is being conducted in 2 parts (Part 1 and Part 2). Otilimab is a human monoclonal anti-granulocyte macrophage colony stimulating factor (GM-CSF) antibody that has not previously been tested in participants with severe pulmonary COVID-19 related disease in Part 1. The aim of this study is to evaluate the benefit-risk of a single infusion of otilimab in the treatment of hospitalized participants with severe COVID-19 related pulmonary disease with new onset hypoxia requiring significant oxygen support or requiring early invasive mechanical ventilation (less than or equal to \[\<=\] 48 hours before dosing). Participants will be randomized to receive a single intravenous (IV) infusion of otilimab or placebo, in addition to standard of care.
Timeline
- Start
- 2020-05-28
- Primary completion
- 2021-07-15
- Completion
- 2021-08-16
Outcome
Mixed primary results
registry Part 1: Placebo 1 vs Part 1: Otilimab 90 mg; p = 0.0456; Odds Ratio (OR) 1.32 (95% CI 0.96 to 1.82) NCT04376684 ↗
registry Part 2: Placebo 2 vs Part 2: Otilimab 90 mg; p = 0.8574; Odds Ratio (OR) 1.04 (95% CI 0.67 to 1.61) NCT04376684 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Otilimab | Monoclonal antibody | — | Intravenous |