NIH-Sponsored ACTIV-3 trial closes LY-CoV555 sub-study. Eli Lilly

The ACTIV-3 clinical trial evaluating the investigational monoclonal antibody LY-CoV555 in hospitalized patients with COVID-19 will not enroll more participants into this sub-study following a recommendation from the independent Data and Safety Monitoring Board (DSMB). The trial is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. ACTIV-3 is a master protocol designed to allow for the study of multiple investigational agents compared to placebo in adults hospitalized with COVID-19. Participants in the trial are randomly assigned to receive either an experimental agent or a matched placebo. All participants also receive standard care for patients hospitalized with COVID-19, including the antiviral remdesivir. After five days, participants’ clinical status is assessed based on an ordinal scale. If the investigational agent appears to be safe and effective based on an evaluation of the first 300 participants (stage 1), an additional 700 participants are randomized and followed for 90 days to assess sustained recovery, defined as being discharged, alive and home for 14 days (stage 2). The DSMB that oversees ACTIV-3 also oversees ACTIV-2, another adaptive trial evaluating LY-CoV555 in the outpatient population. The DSMB does not recommend any changes to ACTIV-2, and this study continues to enroll participants.