The World Health Organization (WHO) has implemented a temporary pause of the hydroxychloroquine arm within the agency’s Solidarity Trial in COVID-19 patients pending a review of safety data by the study’s Data Safety Monitoring Board, said WHO Director General Tedros Adhanom Ghebreyesus on Monday. He stated that “this concern relates to the use of hydroxychloroquine and chloroquine in COVID-19,” but noted that the other arms of the trial are continuing.
The study is comparing four treatment options against standard of care, to assess their relative effectiveness against COVID-19. Specifically, the trial is assessing Gilead Sciences’ experimental antiviral remdesivir, AbbVie’s HIV drug Kaletra (lopinavir/ritonavir), interferon beta-1a, which is used to treat multiple sclerosis, and the antimalarial drugs chloroquine and hydroxychloroquine. So far, over 400 hospitals in 35 countries are actively recruiting participants and nearly 3500 patients have been enrolled from 17 countries, according to Tedros.
He said the safety review will consider data collected so far in the Solidarity Trial, particularly “robust randomised available data, to adequately evaluate the potential benefits and harms from this drug.”
The WHO chief cited findings from a registry analysis published last week in The Lancet that included nearly 15,000 people treated with hydroxychloroquine or chloroquine, either alone or with a macrolide. The authors said “we were unable to confirm a benefit of hydroxychloroquine or chloroquine, when used alone or with a macrolide, on in-hospital outcomes for COVID-19,” adding that the drug regimens were also found to be associated with lower in-hospital survival and a higher frequency of ventricular arrhythmias.
Mike Ryan, head of the WHO emergencies program, said no signals have emerged in the Solidarity Trial that would suggest any problem, and that the decision to temporarily suspend the hydroxychloroquine arm had been taken out of “an abundance of caution.” Meanwhile, WHO chief scientist Soumya Swaminathan stated that “it’s important to continue to gather evidence on the efficacy and safety of hydroxychloroquine,” adding the decision to pause testing in the hydroxychloroquine arm will be reviewed in the next week or two.