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Trials of hydroxychloroquine drug as potential coronavirus treatment resume

WHO have paused trials of hydroxychloroquine on Covid-19 patients: AFP via Getty Images
WHO have paused trials of hydroxychloroquine on Covid-19 patients: AFP via Getty Images

Trials of the hydroxychloroquine drug as a potential coronavirus treatment have resumed after research was temporarily halted over safety concerns.

The World Health Organisation made the decision to pause the trials following the publication of a paper in the Lancet medical journal last month, which found that hydroxychloroquine and chloroquine were linked to an increased risk of death and heart arrhythmias among people severely ill in hospital with coronavirus.

Editors of the Lancet subsequently published an “expression of concern”, saying that “important scientific questions” had been raised about the data used in the study, which was published on May 22.

The drugs, which are used to treat malaria, arthritis and lupus, are being used in a number of trials across the world looking at their effectiveness in treating Covid-19.

US President Donald Trump has been criticised for promoting hydroxychloroquine as a cure for the virus, despite warnings it could be unsafe.

Hydroxychloroquine, among other drugs, is being prioritised under the WHO’s global Solidarity Trial – an international study bringing together various nations’ efforts to test potential coronavirus treatments.

Speaking to the media on Wednesday, WHO director-general Tedros Adhanom Ghebreyesus said the decision to pause the hydroxychloroquine part of the trial was “taken as a precaution while the safety data were reviewed” by its Data Safety and Monitoring Committee.

Dr Tedros said: “On the basis of the available mortality data, the members of the committee recommended that there are no reasons to modify the trial protocol.

“The executive group received this recommendation and endorsed the continuation of all arms of the Solidarity Trial, including hydroxychloroquine.

“The executive group will communicate with the principal investigators in the trial about resuming the hydroxychloroquine arm.”

He added that the safety of all therapeutics being tested in the Solidarity Trial will continue to be closely monitored.

Dr Soumya Swaminathan, the WHO’s chief scientist, said it had looked at its own data while other hydroxychloroquine trials like Recovery in the UK looked at their data.

She said: “We are now fairly confident, not having seen any differences in mortality, the data safety monitoring committees of both Solidarity and Recovery have recommended that the trial can continue.”

Dr Swaminathan emphasised that decisions over trials were “very different from making a recommendation for the use of hydroxychloroquine or any other drug for either treatment or for prevention”.

The authors of the study published in the Lancet said neither hydroxychloroquine nor chloroquine should be used to treat Covid-19 outside clinical trials and added that randomised clinical trials were needed.

The study analysed data from almost 15,000 patients with Covid-19 receiving the drugs and 81,000 people who did not.

But concerns were raised about the data set supplied by US-based healthcare data analytics company Surgisphere Corporation, including criticisms over seemingly high mortality rates linked to drugs that have been routinely prescribed since the 1950s.

The Lancet said an independent audit of the data was ongoing, while Surgisphere said the results of its analyses should not be “over-interpreted” to those yet to develop Covid-19 or those not admitted to hospital.

UK experts had welcomed the WHO’s decision to pause research into hydroxychloroquine, with the Government warning that chloroquine and hydroxychloroquine are not licensed to treat Covid-related symptoms or prevent infection.

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