A new study shows coronavirus patients who took hydroxychloroquine to treat COVID-19 had a higher risk of death than those who weren’t given the drug.
The study, published Friday in the medical journal The Lancet, also found that COVID-19 patients were more likely to develop serious heart arrhythmias if treated with hydroxychloroquine, or its closely related cousin chloroquine.
Arrhythmias can lead to a sudden cardiac death, the report said, but researchers did not associate the study’s fatalities with adverse cardiac affects.
Even though it’s only an observational study – not the gold standard double-blind, randomized, controlled trials – experts say the enormous sample size makes it compelling.
The study comprises of 96,000 coronavirus patients from six different countries who were hospitalized between Dec. 20, 2019 and April 14, 2020. Nearly 15,000 patients were treated with hydroxychloroquine or chloroquine alone or in combination with an antibiotic – similar to the cocktail President Donald Trump said he was taking Monday.
“This is a much, much larger sample size than has ever been reported in regards to hydroxychloroquine and chloroquine,” said Dr. Matthew Heinz, hospitalist at Tucson Medical Center in Arizona. “The results are pretty compelling and fairly consistent.”
In all, 1,868 took chloroquine alone, 3,783 took that plus an antibiotic, 3,016 took hydroxychloroquine alone and 6,221 took that plus an antibiotic.
About 9% of patients taking none of the drugs died in the hospital, versus 16% on chloroquine, 18% on hydroxychloroquine, 22% on chloroquine plus an antibiotic, and 24% on hydroxychloroquine plus an antibiotic.
After taking into account age, smoking, various health conditions and other factors that affect survival, researchers estimate that use of the drugs may have contributed to 34% to 45% of the excess risk of death they observed.
“It really does give us some degree of confidence that we are unlikely to see major benefits from these drugs in the treatment of COVID-19 and possibly harm,” said Dr. David Aronoff, infectious diseases chief at Vanderbilt University Medical Center, who was not involved in the research.
About 8% of those taking hydroxychloroquine and an antibiotic developed a heart rhythm problem vs. 0.3% of the patients not taking any of the drugs in the study. More of these problems were seen with the other drugs, too.
“When you add azithromycin, it’s always worse,” Heinz said. “Cardiac death is something you can’t monitor for, you can’t detect.”
Hydroxychloroquine is an arthritis medicine that can also be used as a prevention or treatment of malaria, a red blood cell infection transmitted by a mosquito bite, according to the Mayo Clinic. It’s available in the U.S. under prescription only. It can also be used to treat discoid lupus erythematosus and systemic lupus erythematosus.
President Trump told reporters during a roundtable discussion with restaurant executives at the White House on Monday that he’s been taking the drug for the past week and a half, along with zinc and an initial dose of the antibiotic azithromycin.
He tweeted his praise for the drug combination Thursday saying it has “a real chance to be one for the biggest game changers in the history of medicine.”
The Food and Drug Administration has warned against taking hydroxychloroquine with antibiotics and has said the malaria drug should only be used for coronavirus in formal studies.
The long list of common side effects hydroxychloroquine, also sold under the brand name Plaquenil, include nausea, vomiting, stomach pain or cramps, loss of appetite, weight loss, diarrhea, dizziness, spinning sensation, headache, ringing in your ears, nervousness, irritability, skin rash, itching or hair loss.
Despite the Lancet study, Heinz doesn’t believe ongoing studies that continue to use the drug in clinical trials should be halted as they have safety monitor boards that can pull the plug if things go awry.
“This is science. COVID-19 isn’t Democrat or Republican. It doesn’t get upset with tweets,” Heinz said. “We’re going to science our way through this (pandemic).”