Another Phase III study finds hydroxychloroquine ineffective

[H]ydroxychloroquine – the malaria and autoimmune disease drug that President Donald Trump promoted as a potential “game changer” early in the Covid-19 pandemic – not only failed to improve outcomes in those with mild-to-moderate disease, but also produced a higher rate of cardiac and liver side effects.

Results of the randomized, controlled, open-label Phase III trial, which took place at more than two dozen sites in Brazil, were published in the New England Journal of Medicine on [July 30]. The study randomized 667 patients to receive hydroxychloroquine or the drug plus the antibiotic azithromycin on top of standard of care or standard of care alone. When patients were measured on the seven-point ordinal scale of improvement in disease, those in the two hydroxychloroquine groups showed no improvement compared with patients who received standard of care alone. Moreover, those receiving hydroxychloroquine more frequently experienced Qt prolongation and elevation of liver enzymes.

The results add to the growing body of evidence not supporting treatment of Covid-19 with hydroxychloroquine, an analogue of chloroquine, which has also been explored without success in Covid-19. Last month, the Food and Drug Administration revoked an emergency use authorization that it had granted to the drug in late March, a move that had been criticized as motivated more by politics than by science.

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