WHO stops hydroxychloroquine trial due to safety concerns

pharmafile | May 26, 2020 | News story | Manufacturing and Production COVID, COVID-19, coronavirus 

The World Health Organization has announced it will stop a global study into the effectiveness of hydroxychloroquine in COVID-19 patients, due to fears over safety.

In a statement, WHO Director-General Tedros Adhanom Ghebreyesus said: “The executive group has implemented a temporary pause of the hydroxychloroquine arm within the solidarity trial while the safety data is reviewed by the data safety monitoring board. The other arms of the trial are continuing.”

This action has been taken due to research published in the Lancet that showed that patients who took the drug were at higher risk of death and heart problems than those who did not. This research highlights that the rush to use hydroxychloroquine and chlorquine may have been ill advised, as many doctors have been prescribing it without concrete evidence of its effectiveness.

The authors of the Lancet paper pulled together results from 96,000 patients taking one of the drugs, with or without an antibiotic such as azithromycin, across 671 hospitals. It assessed data from between 20 December and 14 April.

The death rate among all groups taking the drugs was higher than those who were not given them. One in six of those taking one of the drugs died, while one in five died if they were taking chloroquine with an antibiotic, while one in four died while taking hydroxychloroquine with an antibiotic. The death rate of those not taking the drug was one in 11.

The authors of the study say that while the statistics used are not exactly comparable due to this not being a controlled trial, it still highlights the increased mortality of those taking the drug. It also increased serious cardiac arryhtmias in all groups receiving thetreatment.

Professor Mandeep R. Mehra, the lead author of the study and Executive Director of the Brigham and Women’s hospital advanced heart disease center in Boston, said: “This is the first large-scale study to find statistically robust evidence that treatment with chloroquine or hydroxychloroquine does not benefit patients with Covid-19. Instead, our findings suggest it may be associated with an increased risk of serious heart problems and increased risk of death.

“Randomised clinical trials are essential to confirm any harms or benefits associated with these agents. In the meantime, we suggest these drugs should not be used as treatments for Covid-19 outside of clinical trials.”

The WHO has stated that the treatment is safe to take for people with malaria and auto-immune diseases, and is still going ahead with its trials investigating other potential coronavirus therapies including remdesivir.

Hydroxychloroquine has become infamous due to President Donald Trump touting it as an effective COVID-19 therapy, even going as far to claim he is taking it as a preventative measure.

On Sunday, he claimed he had finished a full program of hydroxychloroquine saying: “Finished, just finished. And by the way, I’m still here. Frankly, I’ve heard tremendous reports. Many people think it saved their lives. Doctors come out with reports. You had a study in France, you had a study in Italy that were incredible studies.”

One of the studies Trump is referring to is the initial research that suggested hydroxychloroquine may be an effective coronavirus treatment. Professor Didier Raoult  carried out a study on 36 people and said he treated 100% of the patients effectively but left out that six dropped out after the first six days and they either died, were transferred to the ICU or couldn’t tolerate the drug.

The results of another study into the use of hydroxychloroquine in COVID-19 patients has cast further doubts on its effectiveness in treating the virus. The research, titled the “Observational Study of Hydroxychloroquine in Hospitalized Patients with Covid-19”, was published in The New England Journal of Medicine. The researchers concluded that: “Hydroxychloroquine administration was not associated with either a greatly lowered or an increased risk of the composite end point of intubation or death. Randomized, controlled trials of hydroxychloroquine in patients with Covid-19 are needed.”

Conor Kavanagh

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