WHO resumes study of hydroxychloroquine for COVID-19 after safety review

The World Health Organization (WHO) on Wednesday said it will continue evaluating hydroxychloroquine as a potential COVID-19 treatment in its international Solidarity Trial, after a data safety monitoring board decided there was no reason to discontinue the study following a review of available data on the drug. "The executive group received this recommendation and endorsed the continuation of all arms of [the Solidarity Trial], including hydroxychloroquine," said WHO Director General Tedros Adhanom Ghebreyesus.

The hydroxychloroquine arm of the trial was suspended late last month due to safety concerns following a recent analysis in The Lancet that suggested patients with COVID-19 treated with hydroxychloroquine or chloroquine, either alone or together with a macrolide, had decreased in-hospital survival and higher rates of ventricular arrhythmia. Researchers were also unable to confirm that patients with COVID-19 derived any benefit from these drug regimens.

"This decision was taken as a precaution while the safety data were reviewed," Tedros noted, but "on the basis of the available mortality data, the members of the committee recommended that there are no reasons to modify the trial protocol." He added that the board will closely monitor the safety of all therapeutics that are being tested in the Solidarity Trial, which includes more than 3500 patients across 35 countries. 

More than 200 scientists have raised concerns about The Lancet study, focusing on Surgisphere, a firm that provided data for the investigation, and they have asked for more transparency about its sources and analytical methods. Surgisphere also provided data for a study published in the NEJM that suggested common hypertension drugs were not raising the risk of death for patients with COVID-19. The editors of both publications have since issued "expressions of concern" regarding the trials. Mandeep Mehra, a cardiologist who worked on The Lancet and NEJM studies, said researchers not affiliated with Surgisphere are reviewing the data used in both papers and will provide their findings to the journals.

Meanwhile, the WHO suspension prompted Sanofi and others to temporarily halt recruitment for their own trials looking into the drug. The French drugmaker said it would review the information and reassess its position following the WHO's decision.

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