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WHO Pauses Hydroxychloroquine Clinical Trial

woman taking a pill

Editor's Note: On June 4, 2020, the editors of The Lancet retracted the findings of its hydroxychloroquine study, saying that data could not be verified. 

May 26, 2020 - The World Health Organization is halting its human trial of hydroxychloroquine, an antiviral drug used for malaria, due to concerns about lethal side effects, the organization announced Monday.

The decision was based on a new study published in The Lancet on Friday, which found that death rates were higher in patients taking the drug. The study reviewed data from 96,000 COVID-19 patients from six continents, including more than 14,000 who had received hydroxychloroquine or chloroquine. The research team found that the drugs increased the risk of dying by more than 35% and doubled the risk of heart problems.

“We were unable to confirm a benefit of hydroxychloroquine or chloroquine … on in-hospital outcomes for COVID-19,” the authors wrote. “Each of these drug regimens was associated with decreased in-hospital survival and an increased frequency of ventricular arrhythmias when used for treatment of COVID-19.”

The WHO has implemented a “temporary pause” on the hydroxychloroquine arm of its Solidarity Trial, which is an international trial of the safety and efficacy of several drugs against COVID-19. The trial has included more than 400 hospitals in 35 countries with 3,500 patients.

The trial’s executive group, which represents 10 of the countries participating, will review the data to evaluate the benefits and harms of hydroxychloroquine. Other arms of the trial will continue.

“WHO will provide further updates as we know more,” Tedros Adhanom Ghebreyesus, WHO director-general, said during a press briefing on Monday.

“I wish to reiterate that these drugs are accepted as generally safe for use in patients with autoimmune diseases or malaria,” he added.

Last Monday, President Donald Trump said during a meeting with restaurant executives at the White House that he was taking hydroxychloroquine to protect himself from the coronavirus. He completed a 2-week course of the drug, said in an interview with the Sunday news program Full Measure.

“And by the way, I’m still here,” Trump said. “To the best of my knowledge, here I am.”

In April, the FDA also issued a caution against the use of hydroxychloroquine or chloroquine for COVID-19 outside of hospitals or a clinical trial due to the risk of heart rhythm issues.

WebMD Health News Brief Reviewed by Arefa Cassoobhoy, MD, MPH on May 27, 2020

Sources

WHO, “Director-General’s opening remarks at the media briefing on COVID-19 – 25 May 2020.”

The Lancet, “Hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19: a multinational registry analysis.”

C-SPAN, “Restaurant Executives Meeting at the White House.”

Full Measure, “May 24, 2020 – Interview with the President.”

FDA, “FDA cautions against use of hydroxychloroquine or chloroquine for COVID-19 outside of the hospital setting or a clinical trial due to risk of heart rhythm problems.”

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