More US veterans sickened by coronavirus who were treated with the malaria drug President Trump touted for treating the disease died than did patients who were given the usual supportive care, a new study reveals.
And the results suggested that the drug, hydroxychloroquine, provided no benefit to the patients who received it.
The nationwide study was not a rigorous experiment. But with 368 patients, it´s the largest look so far of hydroxychloroquine with or without the antibiotic azithromycin for COVID-19, which has killed more than 182,000 people as of Tuesday.
The study was posted on an online site for researchers and has has not been reviewed by other scientists. Grants from the National Institutes of Health (NIH) and the University of Virginia paid for the work.
Meanwhile, the a panel of experts assembled by the NIH also issued recommendations against the use of hydroxychloroquine with the antibiotic to treat COVID-19 on Tuesday, citing concerns over toxicity.
Researchers analyzed medical records of 368 male veterans hospitalized with confirmed coronavirus infection at Veterans Health Administration medical centers who died or were discharged by April 11.
About 28 percent who were given hydroxychloroquine plus usual care died, versus 11 percent of those getting routine care alone.
About 22 percent of those getting the drug plus azithromycin died too, but the difference between that group and usual care was not considered large enough to rule out other factors that could have affected survival.
The malaria drug hydroxychloroquine (pictured) widely touted by President Donald Trump for treating the new coronavirus showed no benefit in an analysis of its use in U.S. veterans hospitals. There were more deaths among those given hydroxychloroquine versus standard care, researchers report (AP Photo/John Locher)
Hydroxychloroquine made no difference in the need for a breathing machine, either.
Researchers did not track side effects, but noted a hint that hydroxychloroquine might have damaged other organs.
The drug has long been known to have potentially serious side effects, including altering the heartbeat in a way that could lead to sudden death.
Earlier this month, scientists in Brazil stopped part of a study testing chloroquine, an older drug similar to hydroxychloroquine, after heart rhythm problems developed in one-quarter of people given the higher of two doses being tested.
Many doctors have been leery of the drug.
At the University of Wisconsin, Madison, ‘I think we´re all rather underwhelmed’ at what´s been seen among the few patients there who’ve tried it, said Dr Nasia Safdar, medical director of infection control and prevention.
Patients asked about it soon after Trump started promoting its use, ‘but now I think that people have realized we don’t know if it works or not’ and needs more study, said Safdar, who had no role in the VA analysis.
The NIH and others have more rigorous tests underway.
Doctors and patients alike are eager to identify an effective treatment for coronavirus.
As the infection has spread like wildfire to more than 182,000 and killed 44,292, in the US, a few existing drugs have emerged as leading candidates.
Of late, hydroxychloroquine and remdesivir, a drug originally developed to treat Ebola, have pulled to the forefront.
Remdesivir is thought to help block viruses’ ability to make copies of themselves, while hydroxychloroquine is being investigated for its ability to stem life-threatening inflammation from a haywire immune response, known as a ‘cytokine storm.’
This is an indirect way of targeting the virus that drives the infection, but the cytokine storm is thought to be the culprit of most deaths.
President Donald Trump has touted hydroxychloroquine as a ‘game-changer’ – despite a lack of scientific evidence to back up that claim
Hydroxychloroquine is already used widely in the treatment of coronavirus patients in China and South Korea.
A recent global survey found that it was the drug most used by doctors around the world to (experimentally) treat their coronavirus patients, and the one they said led to the best results.
But those, again are anecdotal reports.
The latest study underscores concerns raised by many US doctors, including the American Heart Association (AHA).
Of the veterans included in the study, 13.3 percent who were treated with hydroxychloroquine as well as the standard supportive care (primarily, providing oxygen, IV fluids and preventing sepsis) had to be placed on ventilators.
That was little different from the 14.4 percent of patients who did not receive hydroxychloroquine, and still needed mechanical ventilation.
However, 6.9 percent of patient who got hydroxychloroquine and the antibiotic azithromycin wound up on ventilators.
The group that received the experimental drug, supportive care and the antibiotic were also less likely to die of coronavirus and its complications.
With nearly twice as many deaths among the group that only received hydroxychloroquine, however, the researchers advised caution and underscored ‘the importance of awaiting results’ of larger, more thorough studies.
President Trump said of coronavirus patients: ‘What do you have to lose?’
But science suggests they have quite a bit to lose.
The drug is known to cause dangerous side effects – most notably, hear arrhythmias.
As doctors treat more coronavirus patients, they’re seeing several emerging patterns in how the virus attacks parts of the body besides the lungs.
Kidneys and the heart are chief among these secondary victims of coronavirus.
Dr Paul Saunders, head of cardiothoracic surgery at Maimonides Medical Center in Brooklyn, New York, recently told DailyMail.com that doctors are seeing an alarming incidence of heart attacks and other severe cardiovascular complications in COVID-19 patients.
In many instances, he said, these heart problems are what ultimately kills these patients.
So prescribing a drug known to stress the heart could be a recipe for disaster – but it will take more research to know for certain.
WHAT YOU NEED TO KNOW ABOUT HYDROXYCHLOROQUINE AND HOW IT MAY TREAT CORONAVIRUS
By Associated Press and Mary Kekatos, Senior Health Reporter for DailyMail.com
Over the last several weeks, politicians and doctors have been sparring over whether or not to use hydroxychloroquine against the novel coronavirus.
Some say the drug is a ‘game-changer’ while others argue that the evidence is too thin to recommend it now.
Here is everything you need to know about the drug and its potential benefits:
HOW IS IT BEING USED?
Hydroxychloroquine has been in use since the 1940s to prevent and treat malaria, and to treat rheumatoid arthritis and lupus.
It works by helping tame an overactive immune system.
The drug is sold both in generic form and under the brand name Plaquenil in the US.
Physicians also can prescribe it ‘off label’ for other purposes, as many are doing now for COVID-19, the disease caused by the virus.
WHAT’S THE EVIDENCE?
Four small and very preliminary studies give conflicting results.
One lab study suggested hydroxychloroquine curbed the ability of the virus to enter cells.
Another report on 11 people found it did not improve how fast patients cleared the virus or their symptoms.
A third report from China claimed the drug helped more than 100 patients at 10 hospitals, but they had various degrees of illness and were treated with various doses for different lengths of time.
Outside researchers say the patients might have recovered without the drug because there was no group in the report that didn’t get the drug for comparison.
Finally, researchers in China reported that cough, pneumonia and fever seemed to improve sooner among 31 patients given hydroxychloroquine compared to 31 others who did not get the drug.
However, fewer people in the comparison group had cough or fevers to start with. Four people developed severe illness and all were in the group that did not get the drug.
These results were posted online and have not been reviewed by other scientists or published in a journal. Larger, more rigorous studies are underway now.
WHAT’S THE RISK?
The drug can cause heart rhythm problems, severely low blood pressure and muscle or nerve damage.
Taking it outside of a scientific experiment adds the risk of not having tracking in place to watch for any of these side effects or problems and quickly address them if they do occur.