Covid-19: WHO to pause hydroxychloroquine trial on safety concerns

• The WHO DG added that the concern relates only to the particular anti-malarial drug and its potential use on covid-19 patients, and not to other drugs
• In India, the trial is being conducted by ICMR and enrolment for the study at the 19 study sites started on 1 May, data on the government’s clinical trial registry showed

NEW DELHI : The World Health Organization on Monday said that it will temporarily pause the hydroxychloroquine arm of its Solidarity Trial of drugs against covid-19 after an observational study in The Lancet journal estimated higher mortality rate among patients given the medicine.

“The Executive Group of the Solidarity Trial, representing 10 of the participating countries, met on Saturday and has agreed to review a comprehensive analysis and critical appraisal of all evidence available globally," WHO director general Tedros Adhanom Ghebreyesus said in his opening remarks at a press conference.

“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."

Ghebreyesus said that the review will consider data collected so far in the Solidarity Trial and, particularly robust randomised available data, to adequately evaluate the potential benefits and harms from this drug.

On Friday, the Lancet journal published an observational study of more than 96,000 patients showed that the use of hydroxychloroquine or chloroquine, when used alone or with a macrolide, was associated with decreased in-hospital survival and an increased frequency of ventricular arrhythmias when used for treatment of covid-19.

On the other hand, the study was not able to confirm a benefit of hydroxychloroquine or chloroquine, when used alone or with a macrolide.

The WHO DG added that the concern relates only to the particular anti-malarial drug and its potential use on covid-19 patients, and not to other drugs.

In India, the trial is being conducted by the Indian Council of Medical Research, and enrolment for the study at the 19 study sites started on 1 May, data on the government’s clinical trial registry showed.

The Solidarity Trial is also looking at the use of Gilead Sciences Inc’s repurposed Ebola drug remdesivir, the anti-cancer combination of lopinarvir and ritonavir, and the combination drug with Interferon beta-1a.

Among these drugs, remdesivir has so far come up as a front-runner with the US National Institute of Allergy and Infectious Diseases’ (NIAID) study showing a reduction in treatment period getting published in The New England Journal of Medicine last week.

Another drug that is being considered as a potential cure for the fatal respiratory pandemic is the broad-spectrum antiviral favipiravir, for which various trials are underway. However, the drug is not part of the Solidarity Trial.

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