Further evidence demonstrating the lack of efficacy of hydroxychloroquine as a treatment for coronavirus disease 2019 (COVID-19) was detailed in a new randomized, multicenter, blinded, placebo-controlled study published in JAMA.
A new randomized clinical trial provides further evidence that hydroxychloroquine does not improve clinical outcomes for patients hospitalized with coronavirus disease 2019 (COVID-19).
The multicenter, blinded, placebo-controlled study, published in JAMA, included 479 adults hospitalized with respiratory symptoms of COVID-19 at 34 U.S. hospitals from the National Heart, Lung, and Blood Institute PETAL Clinical Trials Network between April 2 and June 19.
Patients were assigned to receive hydroxychloroquine or a placebo, with 242 in the group assigned to receive 400 mg of hydroxychloroquine twice daily for 2 doses, then 200 mg twice daily for 8 doses, and 237 assigned to receive a placebo. They were assessed 14 days after randomization based on a 7-point scale ranging from death to discharge. No significant difference was reported between the two groups (median [interquartile range] score, 6 [4-7] vs 6 [4-7]; adjusted odds ratio, 1.02 [95% confidence interval, 0.73 to 1.42]). At 28 days, 25 patients in each group (10.4% of the hydroxychloroquine group and 10.6% of the placebo group) had died.
“(T)reatment with hydroxychloroquine did not improve or worsen clinical outcomes for adults hospitalized for respiratory illness from COVID-19,” the study concluded. “These findings were consistent in all subgroups and for all outcomes evaluated, including an ordinal scale of clinical status, mortality, organ failures, duration of oxygen use, and hospital length of stay.”
In a corresponding editorial, Michael S. Saag, MD, of the University of Alabama at Birmingham School of Medicine, called the study “among the best published to date” to demonstrate that hydroxychloroquine is not effective for treating moderate or severe COVID-19.
“Several published rigorous studies have demonstrated similar findings,” Saag wrote. “In the well-conducted clinical trials published to date, hydroxychloroquine has been evaluated in a wide variety of populations, ranging from patients with severe illness to individuals at risk of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, in whom the drug was used as primary prophylaxis; these studies failed to show any beneficial effect of the drug.”
He noted that preliminary data from a small study suggested that hydroxychloroquine could possibly improve clinical outcomes. However, no health officials endorsed its use because of a lack of robust data. Still, the treatment became politicized when U.S. President Donald Trump began promoting the drug and authorized the government to purchase and stockpile it and the U.S. Food and Drug Administration issued Emergency Use Authorization, which was later revoked, for hydroxychloroquine to treat COVID-19.
In August, the Infectious Diseases Society of America announced that it was recommending against the use of hydroxychloroquine for COVID-19. Guidance from the American College of Physicians also has said the drug shouldn’t be used as a prophylaxis or treatment for COVID-19.
“The clear, unambiguous, and compelling lesson from the hydroxychloroquine story for the medical community and the public is that science and politics do not mix,” Saag wrote. “Science, by definition, requires diligence and an honest assessment of findings; politics not so much. The number of articles in the peer-reviewed literature over the last several months that have consistently and convincingly demonstrated the lack of efficacy of a highly hyped ‘cure’ for COVID-19 represent the consequence of the irresponsible infusion of politics into the world of scientific evidence and discourse. For other potential therapies or interventions for COVID-19 (or any other diseases), this should not happen again.”