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

Severe Acute Respiratory Syndrome Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

  • COVID-19
  • Severe Acute Respiratory Syndrome
Clinical Trial Details
NCT number NCT04376684
Study type Interventional
Source GlaxoSmithKline
Contact
Status Completed
Phase Phase 2
Start date May 28, 2020
Completion date August 16, 2021
View Details
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