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"COVID-19 Research Trial

Post-exposure Prophylaxis or Preemptive Treatment for SARS-Coronavirus-2


April 22, 2020: Second Interim Analysis Update

On April 22, 2020, 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. We congratulate the study investigators on their enrollment thus far, and we will continue to provide oversight for the trial as specified in the DSMB charter.

Based on the event rate of COVID-19 illness observed in the control group, the sample size can be reduced by approximately one-third with approximately 200 more research participants needed to complete the trial to demonstrate conclusively 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 COIVD-19. The next interim analysis is scheduled for May 6, 2020. Ongoing U.S. enrollment is occurring at www.covidpep.umn.edu and in Canada at: www.covid-19research.ca



Why hydroxychloroquine?

An old drug, a new potential solution

Chloroquine and hydroxychloroquine are FDA-approved medicines that have been used to prevent and treat malaria since the 1950s. Recent work shows that hydroxychloroquine (also known as Plaquenil) may be more active than chloroquine against the current SARS-CoV-2 virus.

In laboratory studies, researchers have identified two medicines, chloroquine and hydroxychloroquine, as having activity against SARS-coronaviruses. The images below show SARS-CoV-1 virus as fluorescent green. As increased doses of chloroquine are added (left to right) the amount of virus (in green) decreases.






Images from Vincent et al. Virology Journal 2005; doi:10.1186/1743-422X-2-69



A full breakdown of our study can be found on the STUDY DETAILS page.

https://covidpep.umn.edu/

https://covidpep.umn.edu/updates "
 

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NYU is doing a very similar study. Eagerly awaiting results.
Will see if the interim analysis tells us anything - they are generally not publicized unless the interim results are so earth shattering (in either direction) they need to terminate the study due to ethical reasons. Public interest in COVID may change that.
 
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