WHO pauses hydroxychloroquine trial to review safety data

The World Health Organization (WHO) said Monday that it is temporarily stopping the hydroxychloroquine portion of a global study into experimental treatments for COVID-19, the disease caused by the novel coronavirus.

WHO Director-General Tedros Adhanom Ghebreyesus said in a news conference that the decision was made so the body could review safety data related to the drug, which is used to treat malaria and lupus and has been touted by President Trump as a way to combat the coronavirus, Axios reported.

The other arms of the “Solidarity Trials” being overseen by the WHO, which involve multiple countries and potential treatments for COVID-19, will continue, Tedros said.

“This concern relates to the use of hydroxychloroquine and chloroquine in COVID-19,” he added. “I wish to reiterate that these drugs are accepted as generally safe for use in patients with autoimmune diseases or malaria.”

The comments from Tedros came just days after a new study found that hospitalized COVID-19 patients who were treated with hydroxychloroquine had a much higher risk of dying than those who did not receive the drug. 

The study, a retrospective analysis that assessed 96,000 patients, was published Friday in the medical journal, The Lancet. Among other things, researchers concluded that patients who were treated with hydroxychloroquine or chloroquine had a higher risk of developing abnormal heartbeats that could result in cardiac arrest.

While the study was not a randomized controlled clinical trial, health experts said that the findings were significant. Tom Frieden, former director of the Centers for Disease Control and Prevention (CDC), said that it didn’t provide a definitive answer on hydroxychloroquine, but he noted that the likelihood that the drug “substantially improves outcomes is very low.”

Trump has repeatedly touted hydroxychloroquine as a potential “game-changer” in the fight to address COVID-19, though health experts have stressed that not enough is known about it to determine its efficacy.

The president revealed last week that he was taking the drug as a preventative measure, sparking alarm from officials. Trump stood by the decision, saying that he believed it provided “an additional level of safety” and claiming that many font-line health care workers were in favor of it. 

He said in an interview that aired on Sinclair Broadcasting Network on Sunday that he had since finished taking the anti-malaria drug. 

“Just finished,” he said. “And by the way, I’m still here.”

The Food and Drug Administration (FDA) in April warned that hydroxychloroquine should only be taken in a hospital or clinical trial. The agency said in its advisory that the recommendation stemmed from reports about COVID-19 patients experiencing serious cardiac events after taking the drugs. 

Michael Ryan, a top WHO official, echoed the advisory while speaking about the anti-malaria drug earlier this month. He said that the drug should only be administered in clinical trials, noting that it has not been found “to be effective in the treatment of COVID-19 or in the prophylaxis against coming down with the disease.”