WHO has announced that it has temporarily discontinued the clinical trials of hydroxychloroquine drug due to safety concerns. The decision follows a large-scale study of COVID-19 patients in the medical journal The Lancet published last week that associated the anti-malaria medication to increased risk of death and heart arrhythmia.
WHO Director-General, Tedros Ghebreyesus in a statement 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.”
"The Executive Group has implemented a temporary pause of the hydroxychloroquine arm within the Solidarity Trial while the data is reviewed by the Data Safety Monitoring Board"-@DrTedros #COVID19
— World Health Organization (WHO) (@WHO) May 25, 2020
The study authors analysed the data from 96,032 coronavirus patients across six continents. 14,888 patients received some combination of the drugs which included hydroxychloroquine, chloroquine, and an antibiotic macrolide, while the rest did not. Researchers observed that those who received the medication had an increased risk of death and developing heart arrhythmia or irregular heartbeat. The drug is safe when used for approved indications such as autoimmune disease or malaria.
WHO will continue its multi-country Solidarity Trials. Initially, it was started with four drugs: remdesivir, HCQ, ritonavir/lopinavir and lopinavir/ritonavir/interferon beta 1a. Now with HCQ trial on pause for at least few weeks, the Solidarity trial will proceed with the other three arms. It will also conduct a swift review of data on antimalarial drug hydroxychloroquine by mid-June.
On Wednesday, the French government banned the treatment of COVID-19 patients with hydroxychloroquine. The move came after the WHO announcement. The Food and Drug Administration has not yet approved any drug for the treatment of COVID-19 and has warned against using hydroxychloroquine outside of clinical trials or hospitals.