The World Health Organization will restart its trial of hydroxychloroquine after getting the all-clear from a safety review, its chief announced today.
The U.N. health body paused enrolling patients in the part of its Solidarity trial studying hydroxychloroquine last week. Officials cited a large, observational study in the Lancet — echoing smaller studies — that suggested the malaria and lupus medication increased the risk of heart disease and death. The Lancet study has since come under fire, with the prestigious medical journal issuing an “expression of concern” about various problems with the data collection and methods.
A safety monitoring committee looked at death rates in both the WHO's Solidarity trial and the U.K.'s Recovery trial, which is also studying hydroxychloroquine, to see if they were different among patients taking that drug. The safety committee “recommended that there are no reasons to modify the trial protocol,” WHO Director General Tedros Adhanom Ghebreyesus said today.
The multinational panel overseeing the trial endorsed that finding and will “communicate with the principal investigators in the trial about resuming the hydroxychloroquine arm of the trial,” Tedros said.
Hydroxychloroquine is one of four medicines under review as potential coronavirus treatments in the Solidarity trial, which Tedros said has enrolled more than 3,500 participants in 35 countries.
WHO officials stressed that they were not endorsing hydroxychloroquine's overall safety or efficacy as a COVID-19 remedy.
“We hope that the ongoing trials will continue until we have definitive answers,” said Soumya Swaminathan, the WHO's chief scientist.
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June 04, 2020 at 12:17AM
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