“If there was ever hope for this drug, this is the death of it.”
The antimalarial drug championed by President Trump as a “game changer” in the fight against COVID-19 led to a significantly higher risk of death among people who received it compared to those who didn’t, according to a new study of 96,000 hospitalized coronavirus patients across six continents.
The study, published Friday in the medical journal Lancet, found that patients treated with hydroxychloroquine, or the related drug chloroquine, were also more likely to develop an irregular heart rhythm, which can lead to sudden cardiac death.
The findings come just four days after President Trump said he was taking hydroxychloroquine to protect against COVID-19, even though there’s no evidence it works as a preventative drug.
After a day of backlash over his announcement that he’s taking an unproven drug, Trump defended his use of hydroxychloroquine on Tuesday, saying the drug “doesn’t hurt people” and that he believed it “gives you an additional level of safety.”
The new study, led Dr. by Mandeep Mehra, a Harvard Medical School professor and physician at Brigham and Women’s Hospital, and doctors at other institutions, indicates otherwise. The study represents the largest analysis to date of the effectiveness—or lack thereof—of treating COVID-19 patients with hydroxychloroquine. Mehra and his colleagues examined medical records of confirmed COVID-19 patients hospitalized between Dec. 20, 2019 and April 14, 2020 at 671 hospitals across the world.
Of the 96,000 patients studied, nearly 15,000 were treated with hydroxychloroquine or chloroquine alone or in combination with a type of antibiotics known as macrolides, such as azithromycin or clarithromycin, within 48 hours of their diagnosis.
The difference in outcomes between those receiving hydroxychloroquine and those who didn’t are jarring. Among patients treated with hydroxychloroquine, there was a 34% increased risk of death and a 137% increased risk of serious heart arrhythmias. For those receiving hydroxychloroquine and an antibiotic, there was a 45% increased risk of death and an astonishing 411% increased risk of serious heart arrhythmias.
Patients who were given chloroquine had a 37% increased risk of death and a 256% increased risk of serious heart arrhythmias, while those taking chloroquine with an antibiotic experienced a 37% increased risk of death and a 301% increased risk of serious heart arrhythmias.
“Our large-scale, international, real-world analysis supports the absence of a clinical benefit of chloroquine and hydroxychloroquine and points to potential harm in hospitalised patients with COVID-19,” the study reads.
While the researchers did not perform a controlled study—which is considered the gold standard approach for medical research—the scope of their effort was enough to convince many scientists of the validity of their findings.
“It’s one thing not to have benefit, but this shows distinct harm,” Eric Topol, a cardiologist and director of the Scripps Research Translational Institute, told the Washington Post. “If there was ever hope for this drug, this is the death of it.”
Mehra’s findings also echo those of other studies released in April, which found the drug had no benefit and may have led to more deaths among coronavirus patients. The FDA even issued a warning, advising people not to take hydroxychloroquine or chloroquine, unless they’re in a hospital setting or participating in a clinical trial.
Trump on Tuesday rejected one of those studies, which analyzed the use of hydroxychloroquine in U.S. veterans hospitals, nonsensically arguing that it was a “Trump enemy statement” and that the researchers “were giving [hydroxychloroquine] to people that were in very bad shape. They were very old, almost dead.”
In reality, the median age of those given hydroxychloroquine in the veterans study was 70 years old, three years younger than Trump. In Mehra’s study, the mean age of patients studied was 54 years old, indicating the drug is dangerous to people of all ages.
“What do you have to lose?” Trump said on Monday.
Increasingly, the answer looks to be: Everything.