NIH Launches Clinical Trial of Hydroxychloroquine for COVID-19

A clinical trial to assess the antimalarial drug hydroxychloroquine as a treatment for adults with the novel coronavirus (COVID-19) is now underway, the U.S. National Institutes of Health said Thursday.

"Many U.S. hospitals are currently using hydroxychloroquine as first-line therapy for hospitalized patients with COVID-19 despite extremely limited clinical data supporting its effectiveness," Wesley Self, M.D., M.P.H., an emergency medicine physician at the Vanderbilt University Medical Center in Nashville, Tennessee, said in an NIH news release. He will lead the new NIH trial.

His team plans to enroll more than 500 adults who are hospitalized with COVID-19 or are in an emergency department and expected to be hospitalized. All patients in the blinded, placebo-controlled study will continue to receive normal care. Some will be randomly selected to receive 400 mg of hydroxychloroquine twice daily for two doses (day 1), then 200 mg twice daily for the subsequent eight doses (days 2 to 5), while others will receive a placebo twice daily for five days. The first participants have been enrolled at the Vanderbilt University Medical Center, the NIH said.

"Effective therapies for COVID-19 are urgently needed," James Kiley, director of the Division of Lung Diseases at the National Heart, Lung, and Blood Institute, said in a statement. "Hydroxychloroquine has showed promise in a lab setting against SARS-CoV-2, the virus that causes COVID-19 and preliminary reports suggest potential efficacy in small studies with patients. However, we really need clinical trial data to determine whether hydroxychloroquine is effective and safe in treating COVID-19."

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