ACTIV-3 Clinical Trial Closes Enrollment into Two Monoclonal Antibody Sub-Studies

March 04, 2021

The ACTIV-3 clinical trial, which is evaluating the safety and efficacy of investigational therapeutics for COVID-19 in hospitalized patients, has closed enrollment in two sub-studies of investigational monoclonal antibodies. The National Institute of Allergy and Infectious Diseases (NIAID) halted the agency-sponsored sub-studies following an interim review and recommendation from the independent data and safety monitoring board (DSMB).

A DSMB analysis determined that the BRII-196 and BRII-198 therapeutics (Brii Biosciences) did not meet the inclusion for criteria for further enrollment in the trial due to futility. A second monoclonal antibody — VIR-7831 (GSK and Vir Biotechnology, Inc.) — met the pre-specified criteria for study continuation, but participants entering the control group had more advanced illness overall than those enrolling in the group receiving the therapeutic. After adjusting data to account for this imbalance, the DSMB recommended that recruitment in the VIR-7831 sub-study should also end due to futility.

The National Institutes of Health noted in the statement that an additional sub-study within ACTIV-3 continues to enroll patients. ACTIV-2, a trial to evaluate the BRII therapeutics in patients with mild to moderate COVID-19 who do not require hospitalization, will continue as well. Additional information about the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) public-private partnership is available online