Clinical Trial in Hospitalized COVID-19 Patients Evaluates Long-Acting Antibody Therapy
ACTIV-3, a master protocol, is sponsored by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health.
An international, randomized, controlled phase 3 clinical trial has begun evaluating the safety and efficacy of an investigational long-acting antibody combination for treating people hospitalized with coronavirus disease 2019 (COVID-19). The trial has an adaptive design allowing investigators to add new sub-studies of additional investigational agents. ACTIV-3, a master protocol, is sponsored by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health.
The new sub-study is evaluating AZD7442, an investigational long-acting antibody combination developed by AstraZeneca. These antibodies are intended to function as a treatment and a means of preventing infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19. However, the ACTIV-3 trial will only be testing its efficacy as a therapeutic, according to the press release.
ACTIV-3 is designed to conduct multiple different trials of experimental therapeutics simultaneously. The placebo group serves as a shared comparison group for 2 or more experimental therapeutics, increasing the chance that participants will receive a therapeutic in this randomized trial.
The new sub-study of AZD7442 will be running concurrently with 2 other sub-studies. One sub-study is evaluating VIR-7831, a SARS-CoV-2 experimental monoclonal antibody developed through a partnership between GlaxoSmithKline and Vir Biotechnology, Inc, while the other is evaluating the combination of BRII-196 and BRII-198, which are 2 investigational SARS-CoV-2 neutralizing monoclonal antibodies manufactured by Brii Biosciences.
Participants in the new ACTIV-3 sub-study will be hospitalized patients with mild-to-moderate COVID-19 and fewer than 13 days of symptoms. Further, they will be randomized to receive either a saline placebo control or 1 of the 3 experimental therapeutics. After 5 days, the participants’ medical condition will be assessed on a pair of 7-point ordinal scales, each ranging from being able to undertake usual activities with minimal or no symptoms to death, according to the press release.
If the outcomes assessed at 5 days indicated that AZD7442 is likely safe and effective after approximately 150 volunteers have received the antibody, enrollment in the trial will be expanded. An additional 700 participants will be enrolled and randomized in the trial following these outcomes.
According to the press release, the expanded pool of participants will allow researchers to better evaluate whether the therapeutic fulfills the trial’s primary endpoint of sustained recovery. Participants will have met this endpoint when they have been discharged from the hospital and have lived at home for 14 consecutive days.
Clinical trial in hospitalized COVID-19 patients evaluates long-acting antibody therapy. NIH. https://www.nih.gov/news-events/news-releases/clinical-trial-hospitalized-covid-19-patients-evaluates-long-acting-antibody-therapy. Published February 8, 2021. Accessed February 12, 2021.