NIH trial finds no benefit from hydroxychloroquine in hospitalized COVID-19 patients
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A National Institutes of Health clinical trial evaluating the safety and effectiveness of hydroxychloroquine for the treatment of adults with coronavirus disease 2019 (COVID-19) has formally concluded that the drug provides no clinical benefit to hospitalized patients. Though found not to cause harm, early findings in June when the trial was stopped indicated that the drug was not improving outcomes in COVID-19 patients. Final data and analyses of the trial, which was funded by the National Heart, Lung, and Blood Institute (NHLBI), part of NIH, was published online on November 9, 2020, in the Journal of the American Medical Association.

The trial, called Outcomes Related to COVID-19 treated with Hydroxychloroquine among Inpatients with symptomatic Disease (ORCHID), began after lab studies and preliminary reports suggested that hydroxychloroquine — commonly used to treat malaria and rheumatic conditions like arthritis — might have promise in treating SARS-CoV-2, the virus that causes COVID-19.

The Prevention and Early Treatment of Acute Lung Injury (PETAL) Clinical Trials Network of NHLBI started the trial in April at 34 hospitals across the United States and enrolled 479 of the expected 510 patients. By June, preliminary evidence indicated hydroxychloroquine was unlikely to offer any benefit.

NIH officials said the careful design, implementation, and oversight of the study was key to its results, as well as the recommendation by a data and safety monitoring board (DSMB) to stop the trial early.

Quote:“Having a rigorously designed clinical trial that captured patient-centered, clinically meaningful outcomes was critical to reaching the unequivocal conclusions about the use of hydroxychloroquine in COVID-19. ORCHID shows that hydroxychloroquine does not improve clinical outcomes in hospitalized COVID-19 patients,” said James P. Kiley, Ph.D., director, Division of Lung Diseases at NHLBI. “We hope this clear result will help practitioners make informed treatment decisions and researchers continue their efforts pursuing other possible safe and effective treatments for patients suffering with this disease.”



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