NIH halts clinical trial of touted malaria drug

The National Institutes of Health said Saturday that it had stopped a clinical trial of hydroxychloroquine, the malaria drug that President Donald Trump promoted to treat and prevent the coronavirus, because it was unlikely to benefit patients.

The halting of the trial, which had aimed to enroll more than 500 patients, is the latest evidence that scientists are increasingly concluding that hydroxychloroquine has disappointed early hopes for it.

“In effect, the drug didn’t work,” said Dr. William Schaffner, a professor of infectious diseases at Vanderbilt University Medical Center.

He said the medical community had been closely watching this trial because it was federally funded, placebo-controlled and run by respected investigators.

“I think we can put this drug aside and now devote our attention to other potential treatments,” Schaffner said.

Trump had called the drug a “game changer” and took it himself in hopes of protecting himself from infection with the coronavirus. Drugmakers donated millions of doses to the federal stockpile, which distributed them to hospitals around the country. The drug was administered to severely ill patients because they had few other options.

On Monday, the Food and Drug Administration revoked the emergency authorization it had granted to hospitals to give hydroxychloroquine and a related drug, chloroquine, to patients. The agency said that the drugs were unlikely to be effective and could carry potential risks.

The NIH said Saturday that an independent oversight board that monitors safety met late Friday and “determined that while there was no harm, the study drug was very unlikely to be beneficial to hospitalized patients with COVID-19,” the disease caused by the virus.

The trial, which was being run by the National Heart, Lung and Blood Institute, a division of the NIH, had enrolled more than 470 patients when the study was stopped. The study sought to learn whether the drug benefited hospitalized patients and those who visited the emergency room and who were likely to be admitted to the hospital. It was one of several placebo-controlled studies that had been organized to test the drug after a series of small, poorly controlled trials showed early signs of a benefit.

But since then, several large trials have been stopped or have not shown the drug to be effective.