A clinical study by the National Institutes of Health conducted in the spring and summer has determined that hydroxychloroquine offers no clinical benefit to patients hospitalized with COVID-19.
NIH announced the findings Monday, noting that although the medication used to prevent or treat malaria wasn’t found to harm patients, early findings when the trial was stopped in June indicated it wasn’t improving COVID-19 patients' outcomes.
The trial evaluated the health and safety of the drug. The results of the study will appear online in the “Journal of the American Medical Association.”
After lab studies and preliminary reports suggested hydroxychloroquine, which is also used to treat arthritis and lupus, might be able to treat coronavirus, the National Heart, Lung, and Blood Institute’s Prevention and Early Treatment of Acute Lung Injury Clinical Trials Network began the trial in April at 34 U.S. hospitals.
At that time, 479 of the expected 510 patients were enrolled. Preliminary evidence indicated in June that it was unlikely that hydroxychloroquine would provide any benefit.
“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 in a statement. “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.”
Between April 2 and June 19, the trial enrolled patients including 290 Hispanic and Black participants and 212 female participants. On average, the patients' age was 57. While all patients were treated as indicated for their condition, they were randomly assigned to a treatment group. Over the course of five days, they received 10 doses of either hydroxychloroquine or a placebo.
Fourteen days after being assigned to a treatment group, researchers assessed each patient’s clinical status. On a scale from one to seven, they rated each patient’s status. One indicated death and seven meant the patient was discharged from the hospital and could perform normal activities. Twelve additional outcomes were also measured, including death that happened 28 days following the participants being assigned to a treatment group.
On day 14, a similar health status was found among patients who received hydroxychloroquine and patients who received a placebo. The majority of participants from the groups rated at a seven and could be released from the hospital and resume usual activities. Also similar was the number of patients from each group who died on day 14. The same was the case on day 28, as 25 of 241 participants in the hydroxychloroquine group had died while and 25 of 236 participants who took the placebo 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, ORCHID trial study leader, emergency medicine physician at Vanderbilt University Medical Center and PETAL Clinical Trials Network investigator said.
According to Self, the trial’s findings were consistent with those conducted in the United Kingdom and Brazil.
WebMD notes that hydroxychloroquine “is not recommended for coronavirus infection, also known as COVID-19, unless you are enrolled in a study.” The Food and Drug Administration has cautioned against using the drug for COVID-19 outside of hospitals and clinical trials due to the risk of heart rhythm issues.
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