Early Data Shows No Benefit of Hydroxychloroquine for COVID-19

Researchers recently found no evidence that the use of hydroxychloroquine, with or without azithromycin, reduced the risk of mechanical ventilation in patients hospitalized with coronavirus, according to a recent study. 

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The retrospective analysis of data from the Department of Veteran Affairs studied 368 patients with confirmed SARS-CoV-2 in all US Veterans Health Administration medical centers. 

“Hydroxychloroquine is at the forefront of drug repurposing candidates Although ongoing randomized, controlled studies are expected to provide more informative evidence about hydroxychloroquine in the coming months, the outcomes observed in our study represent the best available data,” researchers stated. 

“This nationwide retrospective study of the largest integrated healthcare system in the United States provides the largest dataset yet reported of the outcomes of COVID-19 patients treated with hydroxychloroquine, with or without azithromycin, anywhere in the world.”

The study looked at hospitalization (discharge or death), whether ventilation was required, and the result of hospitalization among patients requiring ventilation.

The patients were categorized into three different groups: those treated with hydroxychloroquine, those treated with hydroxychloroquine and azithromycin, and those unexposed to hydroxychloroquine. 

Hydroxychloroquine and azithromycin are used to slow the progression of COVID-19 in seriously ill patients and relieve the acute respiratory symptoms in infected patients.

Researchers did not find a notable difference in the risk of ventilation in either the hydroxychloroquine group or the hydroxychloroquine and azithromycin group, compared to the group not exposed to hydroxychloroquine. 

There was a higher risk of death from any cause in the hydroxychloroquine group and not in the hydroxychloroquine and azithromycin group. Death rates in the hydroxychloroquine group, hydroxychloroquine and azithromycin, and no hydroxychloroquine were 27.8 percent, 22.1 percent, and 11.4 percent, respectively. 

The rate of ventilation in the hydroxychloroquine group, hydroxychloroquine and azithromycin group, and no hydroxychloroquine group were 13.3 percent, 6.9 percent, and 14.1 percent, respectively. 

“Data from ongoing, randomized controlled studies will prove informative when they emerge. Until then, the findings from this retrospective study suggest caution in using hydroxychloroquine in hospitalized COVID-19 patients, particularly when not combined with azithromycin,” researchers stated.

Experts believe hydroxychloroquine is one of the most promising COVID-19 drugs currently being tested. Clinical trials and other studies are currently underway to uncover if the drug is effective against the rapidly spreading coronavirus. 

Although the anti-malarial drug is not approved by FDA, the agency recently issued an emergency use authorization (EUA) for hydroxychloroquine for coronavirus when clinical trials are unavailable or unfeasible. 

As part of the EUA, HHS accepted 30 million doses of hydroxychloroquine sulfate, donated by Sandoz, and chloroquine, donated by Bayer Pharmaceuticals, to distribute to hospitals across the country.  

Frontline workers are vital during the COVID-19 pandemic and must be protected while they battle the virus every day. Repurposed drugs may be the only option to treat COVID-19 for the next 12 to 18 months, until effective vaccines can be developed and manufactured at scale. 

The first large-scale study in the US will be carried out within the next few weeks by Henry Ford Health System to determine the effectiveness of hydroxychloroquine in preventing COVID-19 among healthcare workers and first responders. 

Enrollment for the study of the anti-malarial drug began at the end of March. The study received more than 1,000 volunteers and interim results are expected in 30 days. Final results of the trial are expected in the summer. 

“This is going to be the first major, definitive study in healthcare workers and first responders of hydroxychloroquine as a preventative medication,” said William W. O’Neill, MD, the Henry Ford Health System’s study’s organizer, an interventional cardiologist and researcher who has pioneered multiple treatments for heart disease. 

“There has been a lot of talk about this drug, but only a small, non-blinded study in Europe. We are going to change that in Metro Detroit and produce a scientific answer to the question: Does it work?”