COVID-19 Trials

BREATHE: A Study to Assess the Efficacy and and Safety of Gimsilumab in Subjects with Lung Injury or Acute Respiratory Distress Syndrome Secondary to COVID-19

The BREATHE trial is a multi-center, adaptive, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of gimsilumab in subjects with lung injury or acute respiratory distress syndrome (ARDS) secondary to COVID-19.

Gimsilumab is a monoclonal antibody against granulocyte macrophage-colony stimulating factor (GM-CSF), which is a myeloid cell growth factor and pro-inflammatory cytokine. Late stages of COVID-19 can be marked by a “cytokine storm” and the over-activation of inflammatory myeloid cells that infiltate and damage tissue such as the lungs. Inhibition of GM-CSF may be able to reverse the pathology.

The study consists of a 2 week treatment period (last dose Day 8) and a 22 week follow up period for a total study duration of 24 weeks for each subject. A total of 270 subjects who have confirmed diagnosis of COVID-19 with clinical evidence of acute lung injury or ARDS will be entered into the trial.