Anti-malaria drug taken by Trump linked to coronavirus death risk

Hydroxychloroquine on tray

"This is the first large-scale study to find statistically robust evidence that treatment with chloroquine or hydroxychloroquine does not benefit patients with Covid-19", said Prof Mandeep R. Mehra, lead author of the study and executive director of the Brigham and Women's hospital advanced heart disease center in Boston, US.

But doctors are waiting for the debate about the usefulness of these drugs for COVID-19 to be settled by gold-standard scientific trials, with some results due as soon as next week.

The overall study will involve 40,000 people who work with confirmed or suspected coronavirus patients from Europe, Africa, Asia and South America and will be a double-blind, randomized, placebo-controlled trial.

Despite Trump's enthusiasm for using hydroxychloroquine for COVID-19 treatment, his own government's Food and Drug Administration warns against it.

The biggest risk increase was seen in the group treated with hydroxychloroquine and an antibiotic, where 8 per cent of patients who got the combination developed a heart arrhythmia, compared with 0.3 per cent of those in the comparison group.

The findings come as U.S. President Donald Trump claimed to be taking hydroxychloroquine, which he requested from the White House physician, because he "heard a lot of good stories".

The study, published Friday in the medical journal the Lancet, is the largest analysis to date of the risks and benefits of treating covid-19 patients with antimalarial drugs.

"The FDA is aware of reports of serious heart rhythm problems in patients with COVID-19 treated with hydroxychloroquine or chloroquine, often in combination with azithromycin", the agency said.

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Almost 15,000 of the 96,000 patients in the analysis were treated with hydroxychloroquine or chloroquine alone or in combination with a type of antibiotics known as a macrolide, such as azithromycin, within 48 hours of their diagnosis. "Based upon these findings and others, no one should take hydroxychloroquine with or without an antibiotic unless they are in a randomized controlled trial".

Mehra's group analyzed some 96,000 patients from 671 hospitals on six continents with COVID-19 infection, from December 20 to April 14, all of whom had either died or been discharged from the hospital by April 21. Both drugs can produce potentially serious side effects, particularly heart arrhythmia. Earlier this week, he surprised the world by admitting he was taking the pill as preventive medicine.

Researchers found the 14,888 patients in the treatment group suffered higher mortality when compared to the control group of over 80,000.

The head of Italy's pharmacological agency also says there is little data about the effectiveness of the anti-malaria drug in treating coronavirus. The paper's text has been replaced with a statement that the authors intend to revise the manuscript because of "controversy about hydroxychloroquine and the retrospective nature of their study".

He said it was time to revoke the emergency use authorization issued by the FDA, which approved the drug for seriously ill patients who were hospitalized or for whom a clinical trial was not available.

Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene and Tropical Medicine, said more research was needed, but added: "A definitive answer still awaits the results of the randomised trials, but it is clear that the drugs should not be given for treatment of Covid-19 other than in the context of a randomised trial".

Trying hydroxychloroquine as a Covid-19 treatment was sensible.

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