Hydroxychloroquine, the anti-malarial drug touted by US President Donald Trump as a “game-changer”, has yet again failed to show efficacy in the treatment of COVID-19 patients, said a study. The observational study of HCQ on hospitalised COVID-19 patients has been published in the New England Journal of Medicine.
The study found no “significant association” between the treatment using HCQ and the patients’ need for breathing assistance or the risk of death. The researchers compared the outcomes in patients who received hydroxychloroquine with those in patients who did not with a composite of intubation or death as the primary end-point.
HCQ is not a cure to COVID-19, however, it has been recommended by the national task force for frontline workers as prophylaxis. It has been approved by the Drug Controller General of India (DCGI) for restricted use in an emergency situation under the supervision of a registered medical professional.
Earlier, the US Food and Drug Administration (FDA) had issued a safety communication regarding the known side effects of malaria drug hydroxychloroquine and chloroquine. FDA said that the side effects include serious and potentially life-threatening heart rhythm problems. It added that the drug has received Emergency Use Authorisation for the treatment with risks already in the drug labels.
“The FDA will continue to monitor and investigate these potential risks and will communicate publicly when more information is available,” said FDA Commissioner Stephen M. Hahn in a statement.
The study was conducted on patients admitted at New York-Presbyterian Hospital (NYP)–Columbia University Irving Medical Center (CUIMC), a quaternary, acute care hospital in northern Manhattan. Among the 1446 consecutive COVID-19 patients admitted there between March 7 and April 8, 2020, a total of 70 patients were excluded from the study because of various reasons including intubation or death.
In the study, 811 patients received hydroxychloroquine and 565 did not. Among the patients who received hydroxychloroquine, 45.8 per cent received it in the 24 hours between their presentation to the emergency department and the start of study follow-up, and 85.9 per cent received it within 48 hours after presentation to the emergency department.