Study finds no benefit of anti-malaria drug hydroxychloroquine promoted by Trump
Drug appeared to neither help nor harm COVID-19 patients
THE LARGEST STUDY to date of hydroxychloroquine, the antimalarial drug touted by President Trump as a potential “game-changer” in the treatment of coronavirus, found no evidence of a benefit in treating severely ill COVID-19 patients.
The study, published Thursday in the New England Journal of Medicine, looked at the drug’s effect on COVID-19 patients admitted to New York–Presbyterian Hospital–Columbia University Irving Medical Center from early March through early April.
Researchers examined whether the drug reduced patients’ risk of dying or becoming so sick they had to be intubated and put on a ventilator, and concluded “the risk of intubation or death was not significantly higher or lower among patients who received hydroxychloroquine than among those who did not.”
The study was not a randomized trial — the type of controlled experiment considered the gold standard for determining the effect of a drug. Instead, it was an observational study, meaning doctors were free to make their own judgment of whether to treat patients with hydroxychloroquine or not.
Although it is not approved by the Food and Drug Administration to treat COVID-19, hydroxychloroquine has received “emergency use authorization” from the FDA to be used in hospitals while study results are pending.
The researchers said they could not rule out a benefit or harm of the drug, “but the results do not support the use of hydroxychloroquine at present, outside randomized clinical trials testing its efficacy.” As a result of their study findings, they wrote, “clinical guidance at our medical center has been updated to remove the suggestion that patients with Covid-19 be treated with hydroxychloroquine.”
“We hoped that with our statistical techniques we’d be able to detect a big outcome and we don’t detect that,” said Dr. Joshua Geleris, lead author of the study, which was funded by the National Institutes of Health. “If there was a small benefit or harm we may not be able to detect it.”
Trump has repeatedly promoted the idea that hydroxychloroquine could be an effective treatment for coronavirus patients, calling it a potential “game-changer” and saying at one point last month that he might consider taking it himself, despite having twice tested negative for the virus at that point.
Two very small randomized trials in China, one enrolling 62 patients and one 30 patients, suggested possible benefits from hydroxychloroquine. A trial of 440 patients in Brazil, which tested two dose levels of hydroxychloroquine, was stopped when the higher dose appeared to be linked to dangerous cardiac EKG changes and higher mortality.
Several more large randomized trials are underway in the US, including one directed by doctors at Mass. General Hospital and another being coordinated at the San Francisco VA Health Care System.
“We need a randomized trial to really tell what impact, if any, the drug has,” said Geleris, an internist and assistant professor of medicine at Columbia University Medical Center.