On Mar. 27, 2020, Humanigen announced that the company had submitted an initial protocol synopsis to U.S. Food and Drug Administration (FDA) in support of the company’s plans to initiate a multi-center, U.S., Phase III study in COVID-19 patients.

The study was planned to be a randomized, controlled, clinical trial with lenzilumab for the prevention and treatment of cytokine storm which can lead to ARDS associated with severe acute respiratory syndrome coronavirus 2 infection in COVID-19.