A randomised, double-blind, placebo-controlled, study evaluating the efficacy and safety of otilimab IV in patients with severe pulmonary COVID-19 related disease.
CI: not available
Approval Date: 07 May 2020
This study will test a type of medicine that is a monoclonal antibody called otilimab and is funded by GlaxoSmithKline. Normally, the body's immune system makes antibodies that attack bacteria and viruses and help to fight infection. Monoclonal antibodies are made in a laboratory and have been designed to work as medicines. Otilimab blocks a specific chemical messenger called granulocyte-macrophage colony-stimulating factor (GM-CSF) which is involved in inflammation. Higher levels of GM-CSF are found in the blood and lungs of patients with COVID-19 related severe pulmonary disease. It is thought that blocking GM-CSF will improve lung function, and improve the chances of survival. The purpose of this study is to test how well otilimab works in COVID 19 patients who have developed severe lung complications when compared to standard hospital care. This study will enrol 800 participants. Each participant will receive a single dose of otilimab given as an infusion (IV), or placebo (infusion with no active ingredient) in addition to normal hospital care. There is a 50% chance of receiving otilimab or placebo chosen randomly. The patient will not know which group they belonged to until after the study has finished. Treatment will be given on Day 1 and daily assessments made until they leave from hospital or Day 28, whichever is sooner. There will be follow up assessments at Days 42 and 60. During the study, patients may need a chest x-ray, daily clinical & safety assessments and regular blood tests.
The aim of this randomized, double-blind, placebo-controlled, study is to evaluate the benefit-risk of a single infusion of otilimab in the treatment of hospitalised participants with severe COVID-19 related pulmonary disease.
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