On Mar. 30, 2020, Humanigen announced that the company had submitted an initial protocol synopsis to the FDA in support of the companyﾒs plans to initiate a multi-center, US, Phase III study in COVID-19 patients.

The study was aplnned to be a randomized, controlled, clinical trial with lenzilumab for the prevention of ARDS and/or death in hospitalized patients with pneumonia associated with coronavirus 2 (SARS-CoV-2) infection in COVID-19.