At a glance
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A Randomized, Double-blind, Placebo-controlled, Study Evaluating the Efficacy and Safety of Otilimab IV in Patients With Severe Pulmonary COVID-19 Related Disease
In Brief
A Phase 2 clinical trial evaluating Otilimab, Placebo 1, and 2 other interventions for Severe Acute Respiratory Syndrome. Completed, enrolled 1,156 participants across 120 sites in 19 countries.
Detailed 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.
Study Details
Timeline
Interventions
Otilimab will be administered once via IV route.
Placebo 1 will consist of sterile 0.9 percent (%) sodium chloride solution administered once via IV route.
Placebo 2 will consist of sterile 5% dextrose or 5% glucose solution administered once via IV route.
All participants will receive standard of care as per institutional protocol.