On Oct. 13, 2020, Humanigen announced that the National Institute of Allergy and Infectious Diseases (NIAID), had launched its ACTIV-5 ‘Big Effect Trial’ (ACTIV-5/BET), designed to determine whether certain approved therapies or investigational drugs in late-stage clinical development show promise against COVID-19 and, therefore, merit advancement into larger clinical trials.

ACTIV-5/BET, which was to enroll at as many as 40 US sites, evaluated lenzilumab with remdesivir, compared to placebo and remdesivir, in hospitalized COVID-19 patients with approximately 100 patients assigned to each study arm. Humanigen is providing lenzilumab for the study, which is fully funded by NIH.