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19th October 2021
AZD7442 is a long acting monoclonal antibody combination containing tixagevimab and cilgavimab which are derived from the B-cells donated by convalescent patients after infection with COVID-19. According to a press release from the manufacturer, Astra Zeneca, AZD7442, achieved a significant reduction in severe COVID-19 or death, compared to placebo in non-hospitalised patients with mild to moderate infection.
In august 2021, AstraZeneca announced that AZD7442 reduced the risk of developing COVID-19 by 77% compared to placebo. Now, the manufacturer has released preliminary results come from TACKLE which is a randomised, phase 3 trial, assessing the efficacy of a single 600mg IM dose of AZD7442 compared to placebo for the outpatient treatment of COVID-19. The study recruited adults (> 18 years of age) who were non-hospitalised, with PCR confirmed mild-to-moderate COVID-19 and symptomatic for no more than seven days. Included in the trial were approximately 13% of adults aged 65 years and over 90% of participants had baseline co-morbidities or other characteristics putting them at a high risk of progression to more severe infection with COVID-19 such as cancer, diabetes, obesity, chronic lung disease or asthma, cardiovascular disease or immunosuppression.
The participants were randomised in a 1:1 fashion to either AZD7442 (n = 452) or saline placebo (n = 451), administered in two separate sequential IM injections.The primary endpoint of the study was the composite of either severe COVID-19 or death from any cause through to day 29, although participants will continue to be followed for 15 months.The trial met the primary endpoint, reducing the risk of developing severe COVID-19 or death (from all causes) by 50% compared to placebo, with 18 events in the AZD7442 arm and 37 in the placebo arm and AZD7442 was generally well tolerated in the trial. In addition, the company reports that in a pre-specified analysis among participants who received the combination within five days of symptom onset, AZD7442 reduced the risk of developing severe COVID-19 or death (from any cause) by 67% compared to placebo, with nine events in the AZD7442 arm and 27 in the placebo arm (27/251).
AstraZeneca has already submitted data in the US, to the FDA to seek emergency Use Authorisation for AZD7442 for prophylaxis of COVID-19. AZFD7442 is also being studied as a potential treatment for patients hospitalised with COVID-19 as part of the ACTIV-3 trial.
Source. AstraZeneca press release.