Investigating Otilimab in Patients With Severe Pulmonary COVID-19 Related Disease (OSCAR Trial)

Recruiting in Palo Alto (17 mi)

+113 other locations

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: GlaxoSmithKline

Prior Safety Data

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

Participant Groups

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Part 2: Participants receiving otilimabExperimental Treatment2 Interventions

Participants (age 70 years or above) will receive a single dose of otilimab administered as an IV infusion in addition to standard of care in Part 2.

Group II: Part 1: Participants receiving otilimabExperimental Treatment2 Interventions

Participants (age \>=18 years and \<=79 years) will receive a single dose of otilimab administered as an IV infusion in addition to standard of care in Part 1.

Group III: Part 2: Participants receiving placebo 2Placebo Group2 Interventions

Participants (age 70 years or above) will receive a single dose of matching placebo administered as an IV infusion in addition to standard of care in Part 2.

Group IV: Part 1: Participants receiving placebo 1Placebo Group2 Interventions

Participants (age \>=18 years and \<=79 years) will receive a single dose of matching placebo administered as an IV infusion in addition to standard of care in Part 1.