The U.S. government’s National Institutes of Health launched an official clinical trial of the anti-malaria drug hydroxychloroquine, or HCQ, a medication President Trump has touted as a possible “game changer” in the fight against the coronavirus pandemic.
The NIH’s National Heart, Lung, and Blood Institute (NHLBI) announced Thursday that the first patients had been enrolled at Vanderbilt University Medical Center in Nashville in a trial to assess the drug’s safety and efficacy in the treatment of COVID-19 patients.
The statement did not say how many patients there had been given the drug. It did say the goal of the blind, placebo-controlled clinical trial was to “enroll more than 500 adults who are currently hospitalized with COVID-19 or in an emergency department with anticipated hospitalization,” across “dozens” of centers that form a drug trials network across the U.S. That network is known as the Prevention and Early Treatment of Acute Lung Injury Clinical Trials Network
“All participants in the study will continue to receive clinical care as indicated for their condition. Those randomized to the experimental intervention will also receive hydroxychloroquine,” the statement said.
“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,” said lead researcher for the trial, Dr. Wesley Self of Vanderbilt University Medical Center. “Thus, data on hydroxychloroquine for the treatment of COVID-19 are urgently needed to inform clinical practice.”
President Trump’s assertive backing of the drug as a COVD-19 treatment before any clinical evidence was available to prove it safe and effective for that use put him at odds with his own senior medical experts.
“Preliminary reports suggest potential efficacy in small studies with patients,” NHLBI Division of Lung Diseases Director James P. Kiley said alongside Thursday’s announcement.
“However, we really need clinical trial data to determine whether hydroxychloroquine is effective and safe in treating COVID-19.”