NIH Stops Hydroxychloroquine Trial
Although there was no harm, data and safety monitoring board found the drug 'very unlikely to be beneficial'
MONDAY, June 22, 2020 (HealthDay News) -- The National Institutes of Health announced Saturday that a clinical trial evaluating hydroxychloroquine for the treatment of COVID-19 has been stopped because the drug likely provides no benefit.
The Outcomes Related to COVID-19 treated with hydroxychloroquine among In-patients with symptomatic Disease (ORCHID) study was a blinded, placebo-controlled randomized clinical trial that intended to enroll more than 500 hospitalized COVID-19 patients. Participants were first enrolled in April at Vanderbilt University Medical Center in Nashville, Tennessee, and when the study was stopped, more than 470 patients had been enrolled.
Late Friday, a data and safety monitoring board determined that although the drug caused no harm, it was "very unlikely to be beneficial to hospitalized patients with COVID-19," the NIH wrote in a media advisory.
All trial participants had received clinical care, and those randomly assigned to the experimental intervention also received hydroxychloroquine 400 mg twice daily for two doses on day 1 and then 200 mg twice daily on days 2 to 5. The NIH said participants will now continue to receive standard of care and follow-up as indicated for their condition.