University of Minnesota is leading an important HCQ clinical trial, including collaboration with McGill University Montreal, University of Manitoba and University of Alberta. The initiative is called Post-exposure Prophylaxis / Preemptive Therapy for SARS-Coronavirus-2 (COVID-19 PEP) at ClinicalTrials.gov. Excerpts in italics with my bolds.
Study Objective:
- To test if post-exposure prophylaxis with hydroxychloroquine can prevent symptomatic COVID-19 disease after known exposure to the SARS-CoV-2 coronavirus.
- To test if early preemptive hydroxychloroquine therapy can prevent disease progression in persons with known symptomatic COVID-19 disease, decreasing hospitalizations and symptom severity.
The Intervention Drug is Hydroxychloroquine. 200mg tablet; 800 mg orally once, followed in 6 to 8 hours by 600 mg, then 600mg once a day for 4 consecutive days Other Name: Plaquenil
This is the 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 http://www.covidpep.umn.edu and in Canada at: http://www.covid-19research.ca
via Science Matters
April 24, 2020 at 09:24AM
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