The trial, expected to involve 510 patients, is estimated to be completed in July 2021.
Researchers at Vanderbilt University Medical Center in Nashville will explore the safety and efficacy of hydroxychloroquine in the trial, which will feature half the patients getting the drug and the other half receiving a placebo. Dosing will be 400 milligrams twice on the first day and 200 milligrams twice a day for the next four days.
Researchers will compare the effect of hydroxychloroquine versus placebo by measuring outcomes at day 15 and on some other select days.
“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.
While hydroxychloroquine has shown promise in lab settings against the CCP (Chinese Communist Party) virus, commonly known as novel coronavirus, and preliminary reports suggest potential efficacy in small studies with patients, “we really need clinical trial data to determine whether hydroxychloroquine is effective and safe in treating COVID-19,” he added.
There is no vaccine for COVID-19 and no proven treatments for the disease, though doctors across the nation and in other countries are prescribing hydroxychloroquine and the closely related chloroquine.
The drugs are traditionally used to treat and prevent malaria and to treat lupus and rheumatoid arthritis.
Hydroxychloroquine does have a number of side effects, including seizures and irregular heartbeats.
“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,” Dr. Wesley Self, emergency medicine physician at Vanderbilt University Medical Center and the leader of the trial, said in a statement. “Thus, data on hydroxychloroquine for the treatment of COVID-19 are urgently needed to inform clinical practice.”
Other researchers are also conducting trials on hydroxychloroquine. The University of Minnesota last month announced a 1,500-patient study at hospitals across the nation among those who had high-risk exposure to confirmed COVID-19 patients but don’t have symptoms of the disease.
Researchers at the University of Washington Medical Center in Seattle and New York University’s Langone Health launched a trial of the drug this month, aiming to enroll 2,000 people who have been in close contact with suspected or confirmed COVID-19 cases but aren’t showing any symptoms themselves.