Hydroxychloroquine Didn’t Reduce Death, Ventilation Need in COVID-19

Despite suggestions – and hopes -- that hydroxychloroquine could help reduce severity of COVID-19 infection, a new study of veterans suggests otherwise for the antimalarial. In fact, that drug alone – not in combination with azithromycin –appeared to increase death rates in patients with novel coronavirus. Here is more information.

COLUMBIA, SC – A study involving U.S. military veterans appears to dash hopes that hydroxychloroquine, alone or in combination with azithromycin, would be highly effective in treating COVID-19 infection.

In fact, the study appearing on the medRxiv preprint server identified increased overall mortality in Department of Veterans’ Affairs patients hospitalized for novel coronavirus infection and treated with hydroxychloroquine alone.1

Research was conducted by the University of South Carolina; the Dorn Research Institute at the Columbia, SC, Veterans’ Affairs Health Care System and the University of Virginia.

“Despite limited and conflicting data on the use of hydroxychloroquine in patients with Covid-19, the U.S. Food and Drug Administration has authorized the emergency use of this drug when clinical trials are unavailable or infeasible,” the authors write, adding that anecdotal information suggests that hydroxychloroquine, alone or in combination with azithromycin, is being widely used in COVID-19 therapy.

Researchers sought to determine if the therapy affected mortality rates or the need for mechanical ventilation.

To do that, the study team performed a retrospective analysis of data from 368 patients hospitalized with confirmed SARS-CoV-2 infection in all Veterans’ Health Administration medical centers until April 11, 2020. The review divided patients in groups based on their exposure to hydroxychloroquine alone (HC) or with azithromycin (HC+AZ) as treatments in addition to standard supportive management for COVID-19. Of the participants, 97 were in the HC group, 113 in the HC+AZ group and the remaining 158 just received standard supportive care.

Results indicate that rates of death in the HC, HC+AZ, and no HC groups were 27.8%, 22.1%, 11.4%, respectively, while rates of ventilation in the HC, HC+AZ, and no HC groups were 13.3%, 6.9%, 14.1%, respectively.

“Compared to the no HC group, the risk of death from any cause was higher in the HC group (adjusted hazard ratio, 2.61; 95% CI, 1.10 to 6.17; P=0.03) but not in the HC+AZ group (adjusted hazard ratio, 1.14; 95% CI, 0.56 to 2.32; P=0.72),” the authors report. “The risk of ventilation was similar in the HC group (adjusted hazard ratio, 1.43; 95% CI, 0.53 to 3.79; P=0.48) and in the HC+AZ group (adjusted hazard ratio, 0.43; 95% CI, 0.16 to 1.12; P=0.09), compared to the no HC group.”

Researchers say they found “no evidence that use of hydroxychloroquine, either with or without azithromycin, reduced the risk of mechanical ventilation in patients hospitalized with COVID-19. An association of increased overall mortality was identified in patients treated with hydroxychloroquine alone. These findings highlight the importance of awaiting the results of ongoing prospective, randomized, controlled studies before widespread adoption of these drugs.”

Hydroxychloroquine, an antimalarial used to treat some rheumatoid arthritis and lupus patients, has been promoted as potentially beneficial in patients with COVID-19 -- including by President Donald Trump -- although some medical experts have expressed skepticism.

The FDA’s Emergency Use Authorization was issued for hydroxychloroquine sulfate supplied from the Strategic National Stockpile to treat adults and adolescents who weigh 50 kg or more and are hospitalized with COVID-19 for whom a clinical trial is not available, or participation is not feasible. The agency advises that the suggested dose to treat adults and adolescents who weigh 50 kg is 800 milligrams of hydroxychloroquine sulfate on the first day of treatment and then 400 milligrams daily for four to seven days of total treatment based on clinical evaluation.

Trump also has announced the stockpile of 29 million doses of hydroxychloroquine for use in COVID-19 patients.

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