A Phase 2/3 clinical trial has begun to evaluate a combination investigational monoclonal antibody therapy for its safety and efficacy in people who have mild or moderate COVID-19. The two experimental antibodies, BRII-196 and BRII-198, target SARS-CoV-2, the virus that causes COVID-19. The trial, known as ACTIV-2, is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.
The ACTIV-2 study began on Aug. 4, 2020, with an evaluation of LY-CoV555, an investigational monoclonal antibody discovered by AbCellera Biologics (Vancouver, British Columbia) in collaboration with NIAID’s Vaccine Research Center. LY-CoV555 was developed further and manufactured by Eli Lilly and Company (Indianapolis, Indiana), in partnership with AbCellera. On Nov. 10, 2020, LY-CoV555, also known as bamlanivimab, was granted Emergency Use Authorization by the U.S. Food and Drug Administration(link is external) for treating mild-to-moderate COVID-19 in adults and children over 12 years old who are at high risk for progressing to severe COVID-19 and/or hospitalization. With the initiation of the BRII-196 and BRII-198 experimental monoclonal antibodies in the ACTIV-2 study, the LY-COV555 sub-study will close to enrollment.