Sanofi stops enrolling COVID-19 patients in hydroxychloroquine trials

Henrietta Brewer
June 1, 2020

The Health Ministry Research and Development Agency (Balitbangkes) has issued a circular letter instructing doctors involved in the global clinical Solidarity Trial to suspend the use of hydroxychloroquine for COVID-19 patients over safety concerns.

In the correction issued on Friday, Lancet said that one hospital self-designated as belonging to the Australasia continental designation should have been assigned to the Asian continental designation.

In fact, data cited from Australia has "more in-hospital deaths than had occurred in the entire country during the study period", per the scientists, who are now calling for an independent review.

"A request to the authors for information on the contributing centres was denied".

"Data from Africa indicate that almost 25% of all covid-19 cases and 40% of all deaths in the continent occurred in Surgisphere-associated hospitals, which had sophisticated electronic patient data recording", the scientists wrote. "This indicates the need for further error checking throughout the data base", they wrote.

On Wednesday, France's health ministry cancelled a decree in place for almost two months that had allowed hospital doctors to dispense it in specific situations for COVID-19.

The open letter lists 10 major concerns about statistical analysis and data integrity.

The scientists also said the authors "have not adhered to standard practices in the machine learning and statistics community. They have not released their code or data", the letter stated.

Scientists' challenges to Lancet's article come at a time of growing debate about the risks of rushing to publish new medical findings about Covid-19. "If so, then the conclusions have no value, because the confounding factors that this choice introduces can not be statistically corrected using available data", it said. "Clearly, in this electronic health record driven study, without any inputs of local treatment protocols, we do not know whether the patients chosen were based on severity of symptoms ( as is likely given the short supply of the drug), the number of symptoms observed, or location specific (some hospitals gave it to all, while others gave it a few)", the letter states. France also changed its national recommendation of the drug in COVID-19 treatments and halted all trials.

According to sources, the agency has implemented a provisional pause on the hydroxychloroquine wing of its Solidarity Trial.

"A final decision on the harm, benefit or lack of benefit of hydroxychloroquine will be made once the evidence has been reviewed by the Data Safety Monitoring Board", the body said in a statement. Other arms of the clinical trial will continue to operate for assessing the safety and efficiency of numerous drugs.

The trial on healthcare workers isn't expected to start until Covid-19 case numbers start increasing.

The French government last week revoked a decree authorising hospitals to prescribe hydroxychloroquine for Covid-19 patients after France's public health watchdog warned against its use.

According to the Health Ministry, recommendations to use HCQ have come from various foreign studies confirming its effectiveness, and it has been included in several national and worldwide clinical guidelines, including in Russian Federation. The Indian Council of Medical Research (ICMR) has written a letter to the World Health Organization regarding this.

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