The U.S. government's National Institutes of Health launched an official clinical trial of the anti-malaria drug that President Trump has already touted as a possible "game changer" in the fight against the new coronavirus.
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 the trial of hydroxychloroquine to assess itspatients.
The statement did not say how many patients there had been given the drug already, but noted the goal was to "enroll more than 500 adults who are currently hospitalized withor in an emergency department with anticipated hospitalization," across "dozens" of centers that form a drug trials network across the U.S. called the PETAL 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 areas 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," noted NHLBI Division of Lung Diseases director James P. Kiley in Thursday's announcement. "However, we really need clinical trial data to determine whether hydroxychloroquine is effective and safe in treating COVID-19."