Phase III Randomized, Double-blind, Placebo-controlled, Multi-centre Study in Adults to Determine the Safety and Efficacy of AZD7442, a Combination Product of Two Monoclonal Antibodies (AZD8895 and AZD1061), for Post-exposure Prophylaxis of COVID-19 (STOR
CI: Prof Andrew Ustianowski (not participating)
Approval Date: 19 October 2020
Investigational Study drug AZD7442, a combination of two monoclonal antibodies (AZD8895 and AZD1061) is being studied by AstraZeneca for administration to prevent or treat the Coronavirus Disease 2019 (COVID-19). This Phase III study will assess the efficacy of AZD7442 for the post-exposure prophylaxis of COVID-19 in adults. AZD8895 and AZD1061 are each a type of protein, called a monoclonal antibody. Antibodies are protein molecules that the body produces to help fight infections. Monoclonal antibodies are artificially produced, highly purified antibodies that can be manufactured to use as medical treatments. This study is for adults with a potential exposure to a specific identified individual with laboratory-confirmed SARS-CoV-2 (the virus causing COVID-19), symptomatic or asymptomatic, who are therefore at appreciable risk of imminently developing COVID-19. About 1,125 women and men, 18 years of age or older, will take part in this study. There will be 2 groups in the study. Group 1 will be adults 60 years of age or older who live in long-term care facilities and Group 2 will be adults older than 18 years of age. To learn about AZD7442, it will be compared with a placebo. A placebo looks like the study drug but does not contain the active ingredient found in the investigational study drug. Participants will be randomly assigned a study treatment. "Randomly assigned" means that whatever treatment they get will be by chance. Participants will have a 2 in 3 chance of being given study medication. The study medication will be administered at one time via 2 separate injections. Participants will be in the study for about 1 year in total. Up to approximately 100 sites will participate in this study.
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