WHO suspends hydroxychloroquine trial as possible coronavirus cure after reports of patients dying due to drug
Testing of the drug hydroxychloroquine as a possible treatment for the new coronavirus has been halted because of safety concerns, said the World Health Organization (WHO). The decision was made after a major observational study found that hospitalized Covid-19 patients, treated with hydroxychloroquine and chloroquine, are more likely to die or develop dangerous heart rhythm complications.
The WHO is currently running clinical trials of various drugs to assess what might be beneficial in treating the new coronavirus as part of an initiative called the solidarity trial. It was initiated more than two months ago to evaluate the safety and efficacy of four drugs and drug combinations against Covid-19. Over 400 hospitals in 35 countries are actively recruiting patients and nearly 3,500 patients have been enrolled from 17 countries.
“On Friday, The Lancet published an observational study on hydroxychloroquine and chloroquine and its effects on COVID-19 patients that have been hospitalized. The authors reported that among patients receiving the drug, when used alone or with a macrolide, they estimated a higher mortality rate,” said WHO Director-General Tedros Adhanom Ghebreyesus.
“The executive group (of the solidarity trial) has implemented a temporary pause of the hydroxychloroquine arm within the solidarity trial while the safety data is reviewed by the data safety monitoring board. The other arms of the trial are continuing. This concern relates to the use of hydroxychloroquine and chloroquine in Covid-19,” he said.
The executive group, representing 10 of the participating countries, met on May 23 and has agreed to review a comprehensive analysis and critical appraisal of all evidence available globally. “The review will consider data collected so far in the solidarity trial and in particular robust randomized available data, to adequately evaluate the potential benefits and harms from this drug,” said Dr Ghebreyesus. He added, “I wish to reiterate that these drugs are accepted as generally safe for use in patients with autoimmune diseases or malaria.”
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In the latest study, the researchers found that about 1 in 6 patients treated with chloroquine or hydroxychloroquine alone died in the hospital. About 1 in 5 treated with chloroquine and an antibiotic died and almost 1 in 4 treated with hydroxychloroquine and an antibiotic died. In contrast, about 1 in 11 patients in the control group (those who were not given the drugs) died in the hospital. The study analyzed data from 96,032 hospitalized coronavirus patients and concluded that 10,698 patients taking one of the drug regimens died in the hospital (11.1%) and 85,334 survived to discharge. The team compared this death rate to that of a control group, after accounting for confounding variables, such as age, sex, and underlying risk factors. The death rate among the control group was 9.3%.
The US Food and Drug Administration (FDA) has also cautioned against the use of hydroxychloroquine or chloroquine for Covid-19 outside of the hospital setting or a clinical trial due to the risk of heart rhythm problems.
Meanwhile, US President Donald Trump has repeatedly promoted the anti-malarial drug against medical advice and despite warnings from public health officials that it could cause heart problems. Trump recently said he had “just finished’ taking a two-week course of hydroxychloroquine. “Finished, just finished. And by the way, I'm still here,” he said during an interview. “Well, I've heard tremendous reports about it. Frankly, I've heard tremendous reports. Many people think it saved their lives....Look, if somebody else were promoting it other than me, call it a promotion because I want people to get better. I don't gain anything other than if it's something that helps, that's a good thing. That's what I want. That's all I want. I believe in it enough that I took a program because I had two people in the White House that tested positive. I figured maybe it's a good thing to take a program. You know, we take a little bit of a period of time, I think it was two weeks. But hydroxy has had tremendous, if you look at it, tremendous, rave reviews,” said Trump.
When questioned regarding The Lancet study, White House coronavirus response coordinator Dr Deborah Birx said during a briefing on May 23, “I think the FDA has been very clear on their website about their concerns about hydroxychloroquine, particularly when it’s combined with a macrolide (a class of antibiotics such as azithromycin or clarithromycin).” Dr Birx said the study shows that comorbidity puts individuals at more risk. “I think it’s one of our clearest studies, because there were so many thousands — tens of thousands of individuals involved, that the doctors clearly annotated who had heart disease and who had obesity. And you can see dramatically the increased risk for that,” she said.