A National Institutes of Health (NIH)-led clinical trial evaluating hydroxychloroquine for the treatment of coronavirus disease 2019 (COVID-19) has been halted after a data and safety monitoring board determined that the drug was unlikely to benefit hospitalized patients.
Data from the placebo-controlled randomized trial, which was being conducted by the Prevention and Early Treatment of Acute Lung Injury (PETAL) Clinical Trials Network of the National Heart, Lung, and Blood Institute, showed that hydroxychloroquine use, while not harmful, did not appear to impart any additional clinical benefit over placebo.
More than 470 in-patients with symptomatic disease were enrolled at the time the study was stopped. Patients will now continue to receive standard of care treatment as indicated.
Due to safety concerns, the use of hydroxychloroquine was also recently suspended by the World Health Organization in a global study evaluating COVID-19 treatments. Additionally, due to emerging data suggesting that the agents were unlikely to be effective against COVID-19, the Food and Drug Administration revoked the Emergency Use Authorization for chloroquine and hydroxychloroquine.
For more information visit nih.gov.