A phase 2/3 clinical trial has begun to evaluate a combination of two investigational monoclonal antibodies (BRII-196 and BRII-198) for its safety and efficacy in people who have mild or moderate COVID-19.
The trial, known as ACTIV-2 (Accelerating COVID-19 Therapeutic Interventions and Vaccines), is a public-private partnership to develop a coordinated research strategy for speeding development of the most promising treatments and vaccine candidates.
The randomised controlled trial, being led by the US National Institutes of Health, will initially enrol 220 participants with mild or moderate COVID-19 who are at risk for disease progression. Participants will be followed for 72 weeks.
If there are no serious safety concerns, and the results seem promising, the trial will transition to phase 3, enrolling approximately 622 additional participants, for a total of 842 trial participants. These new participants will be randomised to receive the therapy or a placebo.
The primary objective of the phase 3 trial is to determine if the therapy prevents either hospitalisation or death by 28 days after study entry.
The ACTIV-2 study began on August 4, 2020, with an evaluation of bamlanivimab, which was granted emergency use authorisation in the US in November.