A National Institutes of Health (NIH) clinical trial evaluating the safety and efficacy 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, although evidence shows that taking it causes no harm.
Final data and analysis from the study, which was funded by the National Heart, Lung, and Blood Institute (NHLBI), part of the NIH, are published in the Journal of the American Medical Association.
The study, called Outcomes Related to COVID-19 Treated with Hydroxychloroquine among Inpatients with Symptomatic Disease (ORCHID), began after laboratory studies and preliminary reports suggested that hydroxychloroquine, commonly used to treat malaria and rheumatic conditions such as arthritis, might be promising in the treatment of SARS -CoV-2.
The trial, which began in April in 34 U.S. hospitals, enrolled 479 of the planned 510 patients. By June, preliminary evidence indicated that hydroxychloroquine was unlikely to offer any benefit.
NIH officials said the careful design, implementation and oversight of the study was critical to its results, as was a recommendation by a data and safety monitoring board (DSMB) to stop the trial early.
"Having a rigorously designed clinical trial that captured patient-centered and 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, director of the division of lung disease at NHLBI. "We hope this clear result will help professionals make informed treatment decisions as researchers continue their efforts in pursuing other possible safe and effective treatments for patients with this disease."
"The finding that hydroxychloroquine is ineffective for the treatment of COVID-19 was consistent across patient subgroups and for all outcomes assessed, including clinical status, mortality, organ failure, duration of oxygen use, and duration of hospitalization," said Wesley Self, an emergency medicine physician at Vanderbilt University Medical Center and PETAL Clinical Trials Network investigator who led the ORCHID study.
"Although we hoped that hydroxychloroquine would help, this is also an important finding as we work together to find effective treatments for COVID-19," said Samuel M. Brown, MD, MS, a critical care physician at Intermountain Healthcare
Source: National Institutes for Health
