World Health Organization to resume hydroxychloroquine trial after earlier halt over safety concerns

COVID-19: WHO resumes study on Hydroxychloroquine

Hydroxychloroquine safety study pulled on data integrity concern

The chief investigators of the RECOVERY trial have concluded that hydroxychloroquine is ineffective at treating patients hospitalised with COVID-19.

The Lancet paper analyzed data, purported to be from COVID-19 patients in more than 600 hospitals around the world.

Questions were immediately raised about the findings, with one researcher - Professor Peter Horby who is leading the University of Oxford's large-scale 10,000-patient RECOVERY trial of coronavirus drugs - told the BBC that his team hadn't seen that safety signal in the prospective trial.

US President Donald Trump has taken hydroxychloroquine as a preventative measure against Covid-19, boosting demand for the drug.

The "Randomised Evaluation of COVID-19 therapy" (RECOVERY) trial has stopped enrolling patients to its hydroxychloroquine arm after preliminary results showed the drug had no beneficial effect in patients hospitalised with the virus.

According to the statement, a total of 1,542 patients were randomised to hydroxychloroquine and compared with 3,132 patients randomised to usual care alone.

Following the publishing of the study, the World Health Organisation (WHO) - which has been defunded by the White House amid the coronavirus pandemic - initially halted their trials of the malaria drug as a coronavirus treatment, but in the wake of the new findings have resumed trials on Wednesday.

The World Health Organization immediately suspended the hydroxycholoroquine arm of its global Solidarity trial pending a safety review.

Surgisphere has responded to criticism of their research in a statement on their website where they defend the validity of their data registry, and claim they "clearly outlined the limitations of an observational study that can not fully control for unobservable confounding measures".

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A separate clinical trial on Wednesday in the USA and Canada found that taking hydroxychloroquine shortly after being exposed to COVID-19 does not work to prevent infection significantly better than a placebo.

The Lancet, which first published in 1823, is one of the world's most trusted medical journals.

The authors said in a statement Thursday provided by The Lancet, the medical journal that published the study on May 22, that they made a decision to issue the retraction after Surgisphere Corp., the private company that provided the research data, refused to share the full, detailed data set as part of a review after outside researchers raised concerns.

"Each of these drug regimens was associated with decreased in-hospital survival and an increased frequency of ventricular arrhythmias when used for treatment of COVID-19".

"After publication of our Lancet article, several concerns were raised with respect to the veracity of the data and analysis conducted by Surgisphere Corporation and its founder and our co-author, Sapan Desai, in our publication", authors Mandeep Mehra, Frank Ruschitzka and Amit Patel said in a statement published by The Lancet, Thursday.

The Oxford study is the largest so far to put hydroxychloroquine to a strict test.

The WHO said it had been in contact with the Oxford team on Friday and was looking closely at the results, but its trial will continue for now. "We can now stop using a drug that is useless".

A Guardian investigation had revealed errors in the data which were later explained by Surgisphere as some patients being wrongly allocated to Australia instead of Asia.

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