The National Institutes of Allergy and Infectious Diseases (NIAID) this week began enrolling participants for an international phase three clinical trial of AZD7442, an antibody combination developed by AstraZeneca to treat those hospitalized with COVID-19.
The trial is part of ACTIV-3, a master protocol sponsored by NIAID investigating multiple trials of experimental therapeutics simultaneously. This trial is randomized and controlled to evaluate the safety and efficacy of AZD7442. In general, antibodies are natural creations of the immune system that can prevent viruses from infecting cells by binding to the surface of a virus. AZD7442 was created as both a potential treatment and infection preventative, although ACTIV-3 will only test its efficacy as a therapeutic.
This study’s initial participants will be hospitalized patients with mild-to-moderate COVID-19 and fewer than 13 days of symptoms. After five days, participants’ medical conditions will be assessed on two seven-point ordinal scales, ranging from pursuing normal activities with few or no symptoms to death. If results show that, after five days and approximately 150 volunteer vaccinations, AZD7442 is likely to be safe and effective, enrollment in the trial will be expanded.
Another 700 participants could be enrolled, including those with more severe cases of COVID-19. From there, researchers will be better able to evaluate whether the therapeutic can provide sustained recovery. That endpoint will be reached if patients are discharged from the hospital and live at home for 14 consecutive days after treatment.