Hospitalized COVID-19 patients who were treated with hydroxychloroquine, an anti-malaria drug touted by President Trump, had a much higher risk of death than those who were not, according to a new study of 96,000 patients.
The study, published Friday in the medical journal The Lancet, found that patients who were treated with hydroxychloroquine or chloroquine also faced a much higher risk of abnormal heartbeats, called arrhythmias, which could result in cardiac arrest.
The study looked at patients across six different continents, and is the largest analysis to date on the effects of treating COVID-19 patients with hydroxychloroquine or chloroquine.
Nearly 15,000 of the 96,000 patients in the analysis were treated with hydroxychloroquine or chloroquine alone or in combination with an antibiotic called a macrolide, similar to azithromycin, within 48 hours of their diagnosis.
The study was a retrospective analysis of medical records of patients in 671 hospitals located on six continents, but was not a randomized controlled clinical trial, which is seen as the gold standard in science.
Despite this limitation, experts say the findings are important.
“I think it’s as convincing as this kind of study can be,” said Jesse Goodman, a former Food and Drug Administration (FDA) chief scientist who is currently a professor of medicine at Georgetown University.
“In the light of these results, I think it’s fair to say it’s not looking good for a benefit of these drugs. And there’s accumulating evidence that they may actually be harmful, and a lot of people may end up being harmed by their widespread use,” Goodman said.
Tom Frieden, former director of the Centers for Disease Control and Prevention (CDC), said he doesn’t think the study is the definitive answer on the use of hydroxychloroquine.
“But it means that the likelihood that it’s a dramatic cure, or substantially improves outcomes, is very low,” Frieden said.
There have been numerous studies in recent months about the use of hydroxychloroquine to treat COVID-19, and there has been almost no evidence of any benefit. However, many of the studies have shown an increased risk for heart problems.
Although several randomized controlled trials are underway, the study authors said “there is a pressing need to provide accurate clinical guidance because the use of chloroquine or hydroxychloroquine along with a macrolide is widespread, often with little regard for potential risk.”
The popularity of hydroxychloroquine is skyrocketing, even though there is no real data that shows how it benefits patients. The evidence for its use has been largely anecdotal, or based on the widespread publicity of small, uncontrolled studies.
The popularity of both hydroxychloroquine and azithromycin has led to shortages for people that need them to treat approved conditions.
Hydroxychloroquine is used to treat malaria and conditions such as lupus and rheumatoid arthritis, and has not been approved for the treatment of COVID-19.
Still, the FDA in March used its emergency authority to permit the use of hydroxychloroquine for COVID-19 in situations where clinical trials are unavailable or infeasible.
However, the agency issued a warning roughly a month later that the drug should not be taken outside of a hospital or clinical setting because of the risk of developing heart rhythm problems.
Goodman said he thinks the results of the study should make FDA rethink its emergency use authorization, because the benefit does not exceed the risk.
“It’s sort of sad that this has become politicized,” Goodman said. “Encouraging people to use it for treatment, with the degree of safety concerns that has emerged, really is not a good idea.”
President Trump has promoted the use of hydroxychloroquine for months. He repeatedly implored Americans to ask themselves what they had to lose in taking the drug, touting it as a “game-changer” in the search for a treatment for the virus.
Earlier this week, Trump told reporters he had been taking hydroxychloroquine, in combination with zinc, as a way to prevent getting COVID-19.
“I think it gives you an additional level of safety,” Trump said, downplaying warnings that the drug can cause heart problems in certain patients. He also dismissed studies that showed it had no benefit for patients hospitalized with coronavirus.