Investigating Otilimab in Patients With Severe Pulmonary COVID-19 Related Disease
Status:
Completed
Trial end date:
2021-08-16
Target enrollment:
Participant gender:
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.