France, Italy and Belgium stop hydroxychloroquine for patients; WHO suspends studies

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France, Italy and Belgium have halted the use of hydroxychloroquine to treat patients suffering from COVID-19, while the World Health Organisation has suspended the drug from its global study into experimental coronavirus treatments after safety concerns.

France has cancelled a decree allowing hospital doctors to dispense the medicine, while the Italian Medicine Agency (AIFA) suspended use of hydroxychloroquine for COVID-19 outside clinical trials. Belgium’s medicine agency warned against using the drug to treat the virus any more except within ongoing clinical registered trials. It said trials aiming to evaluate the drug should also take potential risks into consideration.

However the South African trial into chloroquine will continue, reports The Times.

The international trial to test whether the common malaria drug chloroquine can be used to prevent COVID-19 infection among healthy volunteers – which has now received final ethics and regulatory approvals in South Africa – will not be affected by the suspension, reports The Times.

The World Health Organisation (WHO) announced Monday that it was temporarily halting its research on hydroxychloroquine (a derivative of chloroquine) as a treatment, to review safety concerns raised in The Lancet.

The report said the national co-principal investigator for the new chloroquine Crown Coronation study, Professor Bruce Biccard, said of The Lancet’s hydroxychloroquine findings: “They used (the drug) as a treatment on hospitalised patients with moderate to severe COVID-19. We are testing it on healthy volunteers, out of hospital and using it as a pre-exposure prophylaxis – prevention. Their doses were way higher than we would be using in our trial.”

The Crown Coronation study will investigate whether chloroquine prevents infection among health-care workers and, secondly, whether it decreases the severity of infection — testing three different doses.

The WHO Solidarity Trial is testing whether hydroxychloroquine or combinations of three other experimental drugs could be effective treatments for COVID-19 among 3,500 patients in 17 countries.

Crown Coronation study national co-principal investigator Professor Sinéad Delany-Moretlwe, director of research at the Wits Reproductive Health and HIV Institute (RHI) in Johannesburg, is quoted in The Times as saying: “These data do not apply to the use of any (drug) regimen used in the ambulatory, out-of-hospital setting.”

The World Health Organisation has announced, meanwhile, that it will temporarily drop hydroxychloroquine – the malaria drug Donald Trump said he is taking as a precaution – from its global study into experimental coronavirus treatments after safety concerns.

The Guardian reports that the WHO’s director-general Tedros Adhanom Ghebreyesus said in light of a paper published in The Lancet that showed people taking hydroxychloroquine were at higher risk of death and heart problems than those who were not, it would pause the hydroxychloroquine arm of its solidarity global clinical trial.

“The executive group 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,” Tedros said. “The other arms of the trial are continuing,”

He said the concern related only to the use of hydroxychloroquine and chloroquine for COVID-19, adding that the drugs were accepted treatments for people with malaria and auto-immune diseases.

Other treatments in the WHO’s solidarity trial, including the experimental drug remdesivir and an HIV combination therapy, are still being pursued.

Hydroxychloroquine has been licensed for use in the US since the mid-1950s and is listed by the WHO as an essential medicine.

The report says there are numerous trials under way of the two drugs against coronavirus but neither is a proven treatment. The US National Institutes of Health is also running a clinical trial to establish whether the drug, administered with the antibiotic azithromycin, can prevent hospital admissions and death from COVID-19.

Full report in The Times

Full report in The Guardian

The Lancet article

See also

More evidence from France and China that hydroxychloroquine not successful in treating COVID-19

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