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AZD7442 prophylaxis trial met primary endpoint
AZD7442 prophylaxis trial met primary endpoint.
About this update from Astrazeneca Plc
[{"type":"text","content":"\n \n \n \n RNS Number : 2923J\n AstraZeneca PLC\n 20 August 2021\n \n \n \n \n 20 August 2021 07:00 BST\n \n \n \n \n \n AZD7442 PROVENT Phase III prophylaxis trial met primary endpoint\n \n \n in preventing COVID-19 \n \n \n \n \n \n 77% reduced risk of developing symptomatic COVID-19 \n \n \n \n \n \n First long-acting antibody combination to prevent COVID-19\n \n \n \n \n \n Positive high-level results from the PROVENT Phase III pre-exposure prophylaxis trial showed AstraZeneca's AZD7442 achieved a statistically significant reduction in the incidence of symptomatic COVID-19, the trial's primary endpoint. \n \n \n \n \n \n AZD7442, a combination of two long-acting antibodies (LAAB), reduced the risk of developing symptomatic COVID-19 by 77% (95% confidence interval (CI): 46, 90), compared to placebo. The trial accrued 25 cases of symptomatic COVID-19 at the primary analysis.\n \n \n \n \n \n T\n here were no cases of severe COVID-19 or COVID-19-related deaths in those treated with AZD7442. In the placebo arm, there were three cases of severe COVID-19, which included two deaths. \n \n \n \n \n \n AZD7442 is the first antibody combination (non-vaccine) modified to potentially provide long-lasting protection that has demonstrated prevention of COVID-19 in a clinical trial.\n \n \n \n \n \n The trial included \n 5,197 \n participants in a 2:1 randomisation AZD7442 to placebo. The primary analysis was based on 5,172 participants who did not have SARS-CoV-2 infection at baseline.\n \n \n More than 75% of participants had co-morbidities, which include conditions that have been reported to cause a reduced immune response to vaccination. \n \n \n \n \n \n The LAAB was well tolerated and preliminary analyses show adverse events were balanced between the placebo and AZD7442 groups. \n \n \n \n \n \n Myron J. Levin, MD, Professor of Pediatrics and Medicine, University of Colorado School of Medicine, US, and principal investigator on the trial, said: \"The PROVENT data show that one dose of AZD7442, delivered in a convenient intramuscular form, can quickly and effectively prevent symptomatic COVID-19. With these exciting results, AZD7442 could be an important tool in our arsenal to help people who may need more than a vaccine to return to their normal lives.\" \n \n \...