Study Detail

PROVENT

A Phase II/III Randomized, Double-blind, Placebo-controlled, Multi-center Study in Adults to Determine the Safety and Efficacy of AZD7442, a Combination Product of Two Monoclonal Antibodies (AZD8895 and AZD1061), for Pre-exposure Prophylaxis of COVID-19 (

Status: Open

Type: Interventional

Funder: AstraZeneca

Sponsor: AstraZeneca

CI: Prof Andrew Ustianowski (not participating)

IRAS-Number: 289956

CPMS-ID: 47183

Approval Date: 09 October 2020

Description:

Investigational Study drug AZD7442, a combination of two monoclonal antibodies (AZD8895and AZD1061) is being studied by AstraZeneca AB for administration to prevent or treat the Coronavirus Disease 2019 (COVID-19). 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 predisposed to have less protection from a COVID-19 vaccine than most adults, or because they are at a higher risk of exposure to SARS-CoV-2 (the virus causing COVID-19). About 5000 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 less than 60 years of age. The study will take place at approximately 100 sites globally. 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 into the muscle of the buttocks. Each injection of study medication is 150mg. The total dose of AZD7442 will be 300mg. Participants will be in the study for about 1 year in total.

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