The National Institutes of Health (NIH) in the US has announced the initiation of a Phase II/III clinical trial of a combination investigational monoclonal antibody therapy for treating individuals with mild-to-moderate Covid-19.
Manufactured by Brii Biosciences, BRII-196 and BRII-198 are investigational, neutralising monoclonal antibodies that target SARS-CoV-2. These are synthetic forms of antibodies produced by humans.
Sponsored by the NIH unit National Institute of Allergy and Infectious Diseases (NIAID), the trial named ACTIV-2 has master protocol design to analyse various investigational agents in adults with mild-to-moderate Covid-19.
It will analyse the safety and efficacy of the combination therapy in those with mild or moderate Covid-19.
In the initial stage, the study will enrol 220 subjects with mild or moderate Covid-19, who are at risk for disease progression.
The participants will randomly receive either BRII-196 and BRII-198 combination or placebo via intravenous infusions and will be followed up for 72 weeks.
At day 28, an independent Data and Safety Monitoring Board (DSMB) will review the trial data and check whether the therapy is safe, can lower symptom duration and can eradicate viral RNA presence in the body.
On obtaining promising results with no serious safety concerns, the trial will progress to Phase III and will have around 622 additional outpatient participants.
As a primary objective, the Phase III trial will analyse if the therapeutic can prevent either hospitalisation or death by day 28.
Last year, the ACTIV-2 study analysed an investigational monoclonal antibody, LY-CoV555 or bamlanivimab.
It was later granted Emergency Use Authorisation by the US Food and Drug Administration for the treatment of mild-to-moderate Covid-19 in people aged 12 years and above and are at the risk of disease progression and/or hospitalisation.
In August last year, NIH initiated a Phase III clinical trial, named ACTIV-3, to evaluate various types of monoclonal antibodies as potential treatments for hospitalised Covid-19 patients.