Tedros Adhanom Ghebreyesus, the World Health Organization's (WHO) Director-General, said that a clinical trial of hydroxychloroquine (HCQ) on COVID-19 patients has come to "a temporary pause", while the safety data of the the anti-malaria drug was being reviewed.
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According to the WHO chief, The Lancet medical journal on May 22 had published an observational study on HCQ and chloroquine and its effects on COVID-19 patients that have been hospitalized, reports Xinhua news agency.
The authors of the study reported that among patients receiving the drug, when used alone or with a macrolide, they estimated a higher mortality rate. "The Executive Group of the Solidarity Trial, representing 10 of the participating countries, met on May 23 and has agreed to review a comprehensive analysis and critical appraisal of all evidence available globally," Tedros said in a virtual press conference on May 25.
The review will consider data collected so far in the Solidarity Trial and in particular robust randomized available data, to adequately evaluate the potential benefits and harms from this drug, he said. "The Executive Group has implemented a temporary pause of the HCQ 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," Tedros added.
WHO initiated the Solidarity Trial, a plan to evaluate the safety and efficacy of four drugs and drug combinations against COVID-19 more than two months ago, which include HCQ. According to the WHO, over 400 hospitals in 35 countries are actively recruiting patients and nearly 3,500 patients have been enrolled from 17 countries under the Solidarity Trial. Tedros added that the safety concern over the drug related only to the use of HCQ and chloroquine in COVID-19, and "these drugs are accepted as generally safe for use in patients with autoimmune diseases or malaria". "WHO will provide further updates as we know more," he added.