NCT04376684

Investigating Otilimab in Patients With Severe Pulmonary COVID-19 Related Disease

A Randomized, Double-blind, Placebo-controlled, Study Evaluating the Efficacy and Safety of Otilimab IV in Patients With Severe Pulmonary COVID-19 Related Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1,156 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Severe Acute Respiratory Syndrome

Interventions

Type	Name	Description
BIOLOGICAL	Otilimab	Otilimab will be administered once via IV route.
BIOLOGICAL	Placebo 1	Placebo 1 will consist of sterile 0.9 percent (%) sodium chloride solution administered once via IV route.
BIOLOGICAL	Placebo 2	Placebo 2 will consist of sterile 5% dextrose or 5% glucose solution administered once via IV route.
DRUG	Standard of care	All participants will receive standard of care as per institutional protocol.

Timeline

• Start date: 2020-05-28
• Primary completion: 2021-07-15
• Completion: 2021-08-16
• First posted: 2020-05-06
• Last updated: 2024-09-23
• Results posted: 2022-03-09

Locations

120 sites across 19 countries: United States, Argentina, Belgium, Brazil, Canada, Chile, Colombia, France, India, Italy, Japan, Mexico, Netherlands, Peru, Poland, Russia, South Africa, Spain, United Kingdom

Regulatory

• FDA-regulated drug study