A major clinical trial showed the malaria drug hydroxychloroquine had no benefit for patients hospitalized with Covid-19, likely closing the door to the use of the highly publicized medicine in the sickest patients — a use for which it was widely prescribed as the pandemic hit the U.S.
The results come from a study called RECOVERY, funded by the U.K. government, that sought to randomly assign large numbers of patients to multiple potential treatments in the country’s National Health Service. The goal was to rapidly get answers as to what worked and what didn’t.
“Today’s preliminary results from the RECOVERY trial are quite clear – hydroxychloroquine does not reduce the risk of death among hospitalized patients with this new disease,” University of Oxford epidemiologist Martin Landray, one of the study’s leaders, said in a statement. “This result should change medical practice worldwide and demonstrates the importance of large, randomized trials to inform decisions about both the efficacy and the safety of treatments.”
A total of 1,542 received hydroxychloroquine, and 3,132 received usual care. After 28 days of treatment, 25.7% of those on hydroxychloroquine and 23.5% of those received usual care had died, meaning those on hydroxychloroquine were 11% more likely to die. That difference was not statistically significant.
There was “no beneficial effect” on how long patients stayed in the hospital, or on other outcomes.
The results were shared via a press release, which the study’s lead authors shared on Twitter. They have not been peer-reviewed or published in a medical journal. The researchers said that full results would be shared as soon as possible.
Still, experts said even the top-line results showed they were meaningful.
“This is a hugely important finding that will likely end use of the drug in hospitalized Covid patients, given the other existing data as well,” said Walid Gellad, director of the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh. Gellad said that he is curious to see the results of other ongoing studies, and that it is still an open question whether the medicine might work earlier in the disease. “We need real answers there as well,” he said.
Robert Califf, the former Food and Drug Administration commissioner and Alphabet employee, tweeted that the study “essentially rules out benefit of [hydroxychloroquine] in critically ill hospitalized patients.” He wrote that the results showed “no benefit; no major risk.”
In addition to being used for malaria, hydroxychloroquine is prescribed to treat conditions including rheumatoid arthritis and lupus. But it was known to increase the risk of arrhythmias.
The FDA still authorized emergency use of the drug in hospitalized patients in March, citing the possible safety issues.
Concerns were heightened by a May 22 study in British medical journal the Lancet. That study, which claimed to use a database from hundreds of hospitals around the world, seemed to indicate that treatment with hydroxychloroquine increased the death rate and the rate of arrhythmias.
But on Thursday, the Lancet retracted that study at the request of the authors after widespread questions about the database the study used and the company, Surgisphere, that had provided it. The authors not associated with Surgisphere had asked for the data to be audited, and Surgisphere refused. As such, they wrote, “we can no longer vouch for the veracity of the primary data sources.”
On Wednesday, another group of researchers released results from another randomized study, testing whether giving people hydroxychloroquine shortly after they have been exposed to someone with Covid-19 could prevent disease transmission. That study also showed no benefit, thought some researchers, including Gellad and Califf, say some effect is still possible.
“It could still have an effect given very early in disease, although less and less likely every day that passes,” Gellad said.
There are dozens of studies ongoing with hydroxychloroquine, more than for any other potential Covid-19 treatment, including studies that combine it with antibiotics such as azithromycin or doxycycline. But the results appear to show the benefit of putting resources into testing medicines in large randomized trials, the medical gold standard, during a pandemic.
The RECOVERY trial represented an early and large effort at such studies, testing not only hydroxychloroquine but also a pair of HIV drugs, lopinavir and ritonavir, and the steroid dexamethasone. The study was later expanded to also test using plasma from recovered patients to treat those who are still ill.
About the Author Reprints
Well you certainly sanitized that. “The article was retracted at the request of the authors.” Aren’t the authors supposed to find out if the data they’re using was compiled by a science fiction writer and a male model? It was a fraud, probably perpetrated so Gilead could clean up. But I’m sure this new study that appeared 2 days later is legit. And those dozens of other studies that are “ongoing” weren’t the trials cancelled after the Lancet and NEJM published the fraudulent study. The US and UK are rotting from the inside out and the whole world to sees it.
Amen to that Kathy. We are filled with corruption and easily lied to.
Dear STAT: Why are your science writers not reporting on the interesting research that’s revealing COVID-19 is more of a vascular disease??
“Coronavirus May Be a Blood Vessel Disease, Which Explains Everything”
https://elemental.medium.com/coronavirus-may-be-a-blood-vessel-disease-which-explains-everything-2c4032481ab2
https://thehill.com/homenews/administration/495409-va-secretary-defends-use-of-hydroxychloroquine-for-veterans-claims
FTA: “Wilkie also stressed in a call with major veterans organization that patients at their facilities were not being used as “test subjects,” according to The Associated Press.”
Every patient is test subject for Covid-19.
The headline and the article don’t match. The article is about a study of using the drug in hospitalized patients but the original doctor in France who proposed the treatment regimen of using hydroxychloroquine and Azithromycin together never said to use this late in the progression of the disease. Also, publishing preliminary results before peer review isn’t really too ethical.
No mention of the May 27, 2020 paper in the Journal of Epidemiology by Risch (Yale) that shows positive effects early use as a prophylactic.
Another case of Medical Fraud. There are 2 major reasons why these anti Hydroxychloroquine “studies” keep appearing.
1. The people running them are politically motivated. They hate President Trump, so if he approves of a drug it must be deemed ineffective and dangerous.
2. These scientists have financial interests in companies or academic institutions doing vaccine research or clinical trials for vaccines. They hope to cash in on these companies. Look at how the stock market jumps up whenever a company says it just had a successful clinical trial.
While hydroxychloroquine is a long established generic drug and it is cheap to buy and use. There’s No money to be made if hydroxychloroquine is widely used.
Thanks Ken. So glad so many people are seeing all of these lies. Surely our brainwashed college students were never given he skills to investigate facts – “Just go on google to get the answer”. Someone rip apart Google and you change the course of history!
This is because when the patient is critically ill… Then the body has the larger viral count and the proteins in which HCQ become ineffective. At this stage we can’t use the HCQ alone. Further the normal dose can not be used because of the possible cardiovascular side effects in the patient which are now suffering from Respiratory distress.
HCQ is possibly effective in the early stages of infection where it has beneficial effects. However the drug can exert beneficial effect in combination with other potential drugs. This is the infection which required 3 drugs combination therapy in different days or incubation phase.
Y’all’s lies just got exposed once and for all today, it’s all over cable TV. I knew all along because I have access to worldwide internet that has without doubt proven the efficacy of Hydroxychloroquine on Covid-19, particularly when administered early on.
Over 600 doctors in the US have used the drug combination early in the illness. How many Americans died because people were not allowed to make their own choice. The drug combination was held because of a political/left against the right. How tragic and immoral.
A little anecdotal for those who are looking for help in any way they can get it in this new fight for survival, let me suggest something based on my experience.
Keep in mind this is without any scientific evidence, just based on my personal experience. Let me preface this by saying I used to get mostly respiratory illnesses ALL THE TIME (and I use caps not for shouting but for emphasis). Sinus infections multiple times a years with frequent bronchitis, also occasionally getting the flu and a couple tough rounds of pneumonia. Just a terrible track record of respiratory illnesses.
This came all to a screeching halt 5 years ago when I started using an OTC product called Nasacort. I have literally not been sick since that day- NOT ONE DAY. And yes, I hate phrasing it like that as it makes me sound like some carnival barker pimping silly elixirs- however I have certainly nothing to gain with this statement. I don’t use it everyday either, just a squirt per nostril every other day or a couple of times a week depending on if I get moisture in my nose (my cue). I’m 57 years old and have a long, long history of trying everything under the sun from scripts, OTC’s and regiments of vitamins and supplements. Nothing worked to keep me from getting sick, even when I was working out like a madman and in peak health. YMMV, but just look at that fatality rate if your checked into the hospital- 20%+ – simply terrifying! Good luck to everyone.
ps. I also give my son a dose when he seems to have a sniffle (as he has allergies) and at 14, he hasn’t had a respiratory illness either.
Nasacort is a steriod? Maybe you have some inflammatory action going on and the Nasacort gets it to relax?