Covid-19 investigational therapeutics are to be evaluated in large clinical trials. Two controlled, randomized Phase 3 clinical trials have started evaluating investigational monoclonal antibodies for their safety and efficacy in treating people hospitalized with moderate coronavirus infection.
The trials are part of the ACTIV-3 master protocol, which has an adaptive design allowing investigators to add new sub-studies of additional investigational agents.
National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, is sponsoring ACTIV-3.
A sub-study is analysinging VIR-7831, a monoclonal antibody developed through a partnership between GlaxoSmithKline plc and Vir Biotechnology, Inc. While GSK is located in Brentford, United Kingdom, Vir is located in San Francisco.
The other sub-study is evaluating the combination of BRII-196 and BRII-198, two neutralizing monoclonal antibodies manufactured by Brii Biosciences (Durham, North Carolina and Beijing).
Antibodies are infection-fighting proteins naturally made by the immune system. Antibodies can prevent viruses from infecting cells, sometimes by binding to the surface of the viruses. Synthetic versions of these antibodies, prepared in a laboratory, are known as monoclonal antibodies.
Those participating in the new ACTIV 3 sub-studies will be randomized 1:1:1 to receive either a saline placebo, VIR-7831 or the Brii combination. The ACTIV-3 design allows researchers to evaluate each antibody in a small group of volunteers, and then to enroll a larger group of volunteers if the antibody appears safe and effective. Initially, researchers will enroll approximately 450 volunteers who have been hospitalized with mild to moderate Covid-19 with fewer than 13 days of symptoms.
The participants’ symptoms, after five days, will be assessed on a seven-point ordinal scale ranging from being able to undertake usual personal activities with minimal or no symptoms, to death.
If an antibody appears to be safe and effective, each sub-study will enroll an additional 700 people. Three-hundred-fifty of those people will be assigned to receive the intervention, and 350 will receive the placebo. The new group of volunteers may include those with more severe illness.
(With inputs from The OnLook News Research Bureau)