A recent National Institutes of Health (NIH) clinical trial intended to evaluate the safety and effectiveness of hydroxychloroquine for treating hospitalized adult COVID-19 patients has formally concluded the drug shows no benefit to the patients dosed with the drug. While research indicates hydroxychloroquine caused no harm to patients given the drug, early findings released in June indicated the drug did nothing to improve patient outcomes.
A report detailing the final data and analysis of the trial, titled Outcomes Related to COVID-19 treated with Hydroxychloroquine among Inpatients with Symptomatic Disease (ORCHID), is online on the Journal of the American Medical Association (JAMA) website, JAMANetwork.com. The research was funded by the National Heart, Lung and Blood Institute (NHLBI), which is part of NIH.
Researchers launched the trial after lab studies and preliminary reports appeared to suggest that hydroxychloroquine could have potential to treat the virus that causes COVID-19. The drug has been used to treat malaria and various rheumatic conditions, such as arthritis.
NHLBI’s Prevention and Early Treatment of Acute Lung Injury (PETAL) Clinical Trials Network kicked off the ORCHID trial in April at 34 hospitals across the US, enrolling 479 patients out of the targeted 510. By June, researchers reported preliminary evidence pointed toward no benefit in giving hydroxychloroquine to hospitalized COVID-19 patients.
“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 James Kiley, director of 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.”
Enrolled ORCHID trial participants had an average age of 57, included 290 Hispanic and Black participants, and 212 of the patients were women. All participants also received clinical care appropriate for their condition.
Participants were randomly assigned to a treatment group and received 10 doses of either hydroxychloroquine or a placebo over the course of five days. Researchers then assessed each patient’s clinical status 14 days after being assigned to a treatment group; they used a seven-category scale ranging from one (death) to seven (discharged from the hospital and able to perform normal activities).
Researchers also measured 12 additional outcomes, including death that occurred 28 days after the participants’ assignment to a treatment group.
After two weeks, patients who received the drug and those that received the placebo showed similar health status; most participants in both groups were discharged from the hospital and able to perform a range of everyday activities. The number of participants in both treatment groups who died at day 14 was also similar.
At day 28, 25 of 241 patients in the hydroxychloroquine group and 25 of 236 patients in the placebo group had died.
Wesley Self, emergency physician at Vanderbilt University Medical Center and the investigator who led the ORCHID trial, said, “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.”
“Our diverse teams of clinicians and research staff worked nimbly, under extremely difficult circumstances to accomplish what NIH and the PETAL Network do best: ‘gold standard’ studies of important questions for patients suffering from life-threatening conditions,” said Samuel Brown, a critical care physician at Intermountain Healthcare and another investigator who helped to lead the trial. “While we hoped that hydroxychloroquine would help, even this is an important result as we work together to find effective treatments for COVID-19.”
As of Nov. 2, 2020, the Centers for Disease Control and Prevention (CDC) has reported more than 9.1m cases of COVID-19 and more than 230,000 deaths in the US. Numerous other clinical trials exploring other potential treatments for the virus are underway or in the planning stage.
Earlier in the pandemic, President Donald Trump touted hydroxychloroquine as a potential COVID-19 treatment. However, after Trump announced in early October that he himself was diagnosed with the virus, the drug was not among the therapies given to him by his doctors.