A total of 90% of participants enrolled were from populations at high risk of progression to severe COVID-19, including those with co-morbidities.
The trial met the primary endpoint, with a dose of 600mg of AZD7442 given by intramuscular (IM) injection reducing the risk of developing severe COVID-19 or death (from any cause) by 50% compared to placebo in outpatients who had been symptomatic for seven days or less. The trial recorded 18 events in the AZD7442 arm (18/407) and 37 in the placebo arm (37/415). The LAAB was generally well-tolerated in the trial.
AstraZeneca will be discussing the data with health authorities. On 5 October 2021, the Company announced that it had submitted a request to the US Food and Drug Administration for Emergency Use Authorisation for AZD7442 for prophylaxis of COVID-19.
AstraZeneca drug cocktail AZD7442
AZD7442 is the first LAAB with Phase III data to demonstrate benefit in both prophylaxis and treatment of COVID-19 and is easily administered by IM injection.
AZD7442 is a combination of two LAABs - tixagevimab (AZD8895) and cilgavimab (AZD1061) - derived from B-cells donated by convalescent patients after SARS-CoV-2 virus. In August 2021, AstraZeneca announced AZD7442 demonstrated a statistically significant reduction in the risk of developing symptomatic COVID-19 in the PROVENT Phase III pre-exposure prevention trial.
AZD7442 is also being studied as a potential treatment for hospitalised COVID-19 patients as part of the National Institute of Health’s ACTIV-3 trial and in an additional collaborator hospitalisation treatment trial.
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