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AZD7442 PhIII trial positive in COVID outpatients
AZD7442 PhIII trial positive in COVID outpatients.
About this update from Astrazeneca Plc
[{"type":"text","content":"\n \n \n \n RNS Number : 5779O\n AstraZeneca PLC\n 11 October 2021\n \n \n \n \n 11 October 2021 07:00 BST\n \n \n \n \n \n AZD7442 reduced risk of developing severe COVID-19 or death \n \n \n in TACKLE Phase III outpatient treatment trial \n \n \n \n \n \n Trial met primary endpoint\n \n \n \n \n \n AZD7442 is the only long-acting antibody combination shown \n \n \n to both prevent and treat COVID-19\n \n \n \n \n \n Positive high-level results from the TACKLE Phase III COVID-19 treatment trial showed AstraZeneca's AZD7442, a long acting antibody (LAAB) combination, achieved a statistically significant reduction in severe COVID-19 or death compared to placebo in non-hospitalised patients with mild-to-moderate symptomatic COVID-19. \n \n \n \n \n \n A total of 90% of participants enrolled were from populations at high risk of progression to severe COVID-19, including those with co-morbidities.\n \n \n \n \n \n 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.\n \n \n \n \n \n In a prespecified analysis of participants who received treatment 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 (9/253) and 27 in the placebo arm (27/251).\n \n \n \n \n \n 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.\n \n \n \n \n \n Hugh Montgomery, Professor of Intensive Care Medicine at University College London, and TACKLE principal investigator, said: \"With continued cases of serious COVID-19 infections across the globe, there is a significant need for new therapies like AZD7442 that can be used to protect vulnerable populations from getting COVID-19 and can also help prevent progression to severe disease. These positive results show that a convenient intramuscular dose of AZD7442 could pl...