Hydroxychloroquine, a drug Trump touts, now being tested in humans to treat coronavirus

Clinical trials for antiviral drug hydroxychloroquine have begun with 500 adults, according to the National Institutes of Health.

The drug used to treat malaria and arthritis will be tested for coronavirus treatment at Vanderbilt University Medical Center in Nashville, NIH said. The blinded, placebo-controlled clinical trial will be done with adults currently hospitalized with COVID-19.

“Effective therapies for COVID-19 are urgently needed,” said James P. Kiler, director of Lung Disease for NIH’s National Heart, Lung and Blood Institute. “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.”

President Donald Trump has touted the drug, saying in a White House press briefing earlier this week “we hear great results” about it.

He also said in a tweet the drug could be “one of the biggest game changers in the history of medicine,” when taken with azithromycin, an antibiotic commonly known as a Z-pack.

Trump pointed to a France study as reason for his optimism for the drug cocktail, but its publisher later said the study “does not meet the Society’s expected standard.” The study included 20 patients.

Scott Gottlieb, who was the U.S. Food & Drug Commissioner under Trump until 2019, has called for more research of the drug.

“If the drug combo is working its effect is probably subtle enough that only rigorous and large-scale trials will tease it out,” he tweeted Sunday.

The new Vanderbilt study is only testing hydroxychloroquine, but researchers hope they can obtain results to find the first coronavirus therapy.

“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 Wesley Self, a Vanderbilt physician leading the trial. “Thus, data on hydroxychloroquine for the treatment for COVID-19 are urgently needed to inform clinical practice.”

The drug’s risks can include “cardiac arrhythmias, seizures, dermatological reactions and hypoglycemia,” NIH said.

Trump said Tuesday he is still hopeful about the drug despite the side effects.

“The side effects are the least of it,” he said. “You have people dying all over the place.”

This story was originally published April 9, 2020 at 11:07 AM with the headline "Hydroxychloroquine, a drug Trump touts, now being tested in humans to treat coronavirus."