Today, the independent Data and Safety Monitoring Board (DSMB) for the #COVID-19 post-exposure prophylaxis trial has reviewed the cumulative safety data from 783 participants in the ongoing #hydroxychloroquine prevention trial.
The DSMB has identified no safety concerns or efficacy concerns at this time. Based on the event rate of #COVID19 illness observed in the control group, the sample size can be reduced by one-third with ~200 more research participants needed to complete the trial.
The trial objective is to demonstrate conclusively in a double-blind randomized placebo-controlled trial whether or not there is a 50% reduction in symptomatic illness with a 5-day course of #Hydroxychloroquine after a high-risk exposure to someone with #coivd19.
The next interim analysis is scheduled for May 6, 2020. Ongoing U.S. enrollment is occurring at http://www.covidpep.umn.edu  and in Canada at: http://www.covid-19research.ca  We are searching for volunteers who have been exposed to COVID19 within <4 days.
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