NIH hydroxychloroquine trial shows drug does not benefit adults hospitalized with COVID-19

Results of a clinical trial of hydroxychloroquine by the National Institutes of Health (NIH) have shown that the drug provides no clinical benefit to adults hospitalized with COVID-19, and no improved outcomes, though it did not cause harm.

Published in the Journal of the American Medical Association and funded by the National Heart, Lung and Blood Institute (NHLBI), the trial’s results were foreshadowed by its cancellation in June, when the NIH first noted hydroxychloroquine was not improving outcomes. The drug remains a common treatment for malaria and rheumatic conditions like arthritis.

“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,” said Dr. James Kiley, director of the Division of Lung Diseases at NHLBI. “ORCHID shows that hydroxychloroquine does not improve clinical outcomes in hospitalized COVID-19 patients. 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.”

In all, 479 people were enrolled in the Outcomes Related to COVID-19 treated with Hydroxychloroquine among Inpatients with symptomatic Disease, or ORCHID, trial. It began in April, randomly assigning a mix of Hispanic and Black participants to a treatment group, where they received either 10 doses of hydroxychloroquine or a placebo over the course of five days. Each patient was then assessed after 14 days.

Similar results were found among placebo and hydroxychloroquine patients, including deaths. By day 28, 25 patients in both groups had died.

“The finding that hydroxychloroquine is not effective for the treatment of COVID-19 was consistent across patient subgroups and for all evaluated outcomes, including clinical status, mortality, organ failures, duration of oxygen use, and hospital length of stay,” Dr. Wesley Self, emergency medicine physician at Vanderbilt University Medical Center and PETAL Clinical Trials Network investigator who led the ORCHID trial, said.