AZD7442, an investigational long-acting antibody combination, is being evaluated in an international randomized, controlled Phase 3 clinical trial as part of the National Institutes of Health Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) master protocol. In this sub-study, the safety and efficacy of AZD7442 will be tested as a treatment therapy for SARS-CoV-2 infection.
In the ACTIV-3 master trial, the AZD7442 sub-study will be conducted simultaneously with two other sub-studies evaluating other SARS-CoV-2 monoclonal antibodies, VIR-7831 and the combination of BRII-196 and BRII-198.
Initial participants of this trial included hospitalized patients with mild-to-moderate COVID-19 infection and fewer than 13 days of symptoms. Researchers will randomize patients to receive either a saline placebo or 1 of the 3 previously mentioned experimental antibodies and will assess their medical condition using two 7-point ordinal scales after 5 days.
Once AZD7442 has been given to approximately 150 patients and the 5-day assessments demonstrate this long-acting antibody both safe and effective, trial enrollment will be expanded to 700 participants. The expansion may include patients with more severe cases of COVID-19 and will allow investigators to determine if this therapy meets the primary endpoint of sustained recovery. Sustained recovery is defined as patients discharged from the hospital and have lived at home for 14 consecutive days.
Despite the ACTIV-3 trial only testing its therapeutic efficacy, AZD7442 may also be a potential preventative treatment of COVID-19, though further research is warranted.
Clinical trial in hospitalized COVID-19 patients evaluates long-acting antibody therapy. National Institutes of Health. Published online February 8, 2021. Accessed February 26, 2021. https://www.nih.gov/news-events/news-releases/clinical-trial-hospitalized-covid-19-patients-evaluates-long-acting-antibody-therapy