The World Health Organization (WHO) said Wednesday that the ongoing Solidarity Trial, which compares potential treatments for COVID-19, is no longer including the malaria drug hydroxychloroquine. According to Ana Maria Henao Restrepo, medical officer at the WHO's department of immunisation vaccines and biologicals, evidence from both internal and external studies "suggest that hydroxychloroquine, when compared with the standard of care in treatment of hospitalised COVID-19 patients, does not result in the reduction of mortality of those patients."
The move comes after the WHO temporarily paused enrolling patients in that arm of Solidarity in late May after findings from a now-retracted study in The Lancet suggested that there was a higher risk of ventricular arrhythmia and death in COVID-19 patients who took chloroquine and hydroxychloroquine. That arm of the study was resumed about two weeks ago following a safety review by the agency.
Henao Restrepo noted that the latest decision to cut hydroxychloroquine from the Solidarity Trial does not "constitute WHO policy, that this is not a WHO policy recommendation," or a reflection on if or how hydroxychloroquine may work as a possible prophylaxis.
Latest setback for malaria drug in COVID-19
Earlier the month, the University of Oxford-led RECOVERY study, which is testing various treatments versus standard care in COVID-19 as well, also stopped enrolling patients in its hydroxychloroquine arm after preliminary results indicated the drug provided "no clinical benefit" to patients hospitalised with the infection. More recent results from RECOVERY showed instead that low-dose dexamethasone cut the risk of death by 35% in hospitalised COVID-19 patients on ventilation.
Meanwhile, the FDA earlier this week withdrew an emergency-use authorisation that had permitted hydroxychloroquine and chloroquine products donated to the US Strategic National Stockpile to be given under certain conditions to hospitalised patients with COVID-19. The FDA said new data suggest the drugs "may not be effective to treat COVID-19" and their "potential benefits for such use do not outweigh…known and potential risks."
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