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EXCLUSIVE-Sanofi stops enrolling COVID-19 patients in hydroxychloroquine trials

Reuters | Updated: 30-05-2020 00:36 IST | Created: 30-05-2020 00:08 IST
EXCLUSIVE-Sanofi stops enrolling COVID-19 patients in hydroxychloroquine trials
Representative image Image Credit: Twitter(@sanofi )

Sanofi has temporarily stopped recruiting new COVID-19 patients for two clinical trials on hydroxychloroquine and will no longer supply the anti-malaria drug to treat COVID-19 until concerns about safety are cleared up, it said on Friday.

The moves come after the World Health Organization paused its large trial of hydroxychloroquine, prompting several European governments to ban the use of the drug, also used in rheumatoid arthritis and lupus. That dealt a major blow to hopes for a treatment, touted by U.S. President Donald Trump, as drugmakers and governments race to find ways to treat patients and control the novel coronavirus.

Sanofi has been conducting two randomised, controlled clinical trials of hydroxychloroquine for COVID-19. The first was expected to test 210 patients in United States, France, Belgium and the Netherlands who were not in hospital and suffering from the early stage of the disease while the second focused on hospitalised patients with moderate to severe COVID-19 in Europe. It was planned to include around 300 patients.

The WHO's concerns centred on a report published by British journal The Lancet that patients getting the drug had increased death rates and irregular heartbeats. The Lancet on Friday issued a correction to the study regarding the location of some patients following criticism of its methodology, but said the conclusions were not changed. The study was not a randomised trial but rather a retrospective analysis of medical records.

Sanofi and rival Novartis have pledged donations of tens of millions of doses of the drug for COVID-19. Last month, the French company said it had already doubled production capacity at eight sites and was poised to increase further.


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