Patients treated with hydroxychloroquine have no better chance of survival than those who don’t receive the drug hailed by Trump as a ‘game-changer’, results of a New York state Health Department trial suggest.
Ultimately, the study, conducted by SUNY at Albany, is intended to involved some 4,000 coronavirus patients, but the preliminary results are from a sample of 600 patients.
Survival rates were no better among the group treated with the experimental drug than among those who got the standard supportive care, including oxygen, IV fluids and, if necessary, mechanical ventilation.
On Friday, shortly after preliminary results were reported, the Food and Drug Administration (FDA) formally warned against using the drug outside of hospitals due to the risk that it could cause heart arrhythmias.
Early results of a trial using hydroxychloroquine to treat coronavirus patients found that they fared no better than those treated with standard supportive care (file)
It’s a major blow to President Trump, who has sung the praises of the drug, as well as to the global search for an effective treatment for coronavirus.
More than 50,000 Americans have died of coronavirus, and 890,000 have been infected.
Officials and doctors alike have hoped that hydroxychloroquine, a drug developed nearly half a century ago to treat malaria, might improve coronavirus patients’ odds by combating severe inflammation resulting from the viral infection.
In lab tests, the drug showed promise, appearing to quell the ‘cytokine storm’ of immune signalling cells that causes inflammation to run wild in the body, overwhelming the lungs.
Hydroxychloroquine interacts with the human immune response, making it useful in treating autoimmune diseases like lupus.
It was even added the official lists of treatments to try for doctors treating COVID-19 patients in China and South Korea, a French study suggested a near 100 percent recovery rate for those treated with hydroxychloroquine, and it was voted the most ‘effective’ treatment (anecdotally) in an international survey of doctors.
But the latest early results suggest that there’s no objective benefit from using the drug.
President Trump has touted hydroxychloroquine as a ‘game-changer’ for treating COVID-19 – despite the fact the drug hasn’t been proven effective
New York Governor Andrew Cuomo said on CNN on Thursday night that review had shown no positive or negative effect
Of the 600-some coronavirus patients treated at 22 New York City area hospitals, some were treated with hydroxychloroquine alone, others were treated with the malaria drug plus the antibiotic azithromycin, and a third group got only the typical supportive care.
‘We don’t see a statistically significant difference between patients who took the drugs and those who did not,’ Dr David Holtgrave, who led the SUNY Albany study told CNN.
Notably, there were not higher rates of heart problems among the patients given hydroxychloroquine, despite the potential for dangerous arrhythmias as a side effect.
It comes after a Veteran Affairs study found that more COVID-19 patients treated with hydroxychloroquine died than did those who didn’t receive the drug.
Dr Holtgrave stressed, however, that the results of his stud are preliminary findings of an ongoing study that have not been peer-reviewed or published.
With no effective treatment or a vaccine, coronavirus continues to kill thousands of Americans a day, with the death toll surpassing 50,000 by Friday
Dr Holtgrave and his team expect the full research, inclusive of 1,200 patients, will be ready for release as early as next week.
‘Hopefully what we’ve done here is to start collecting data and evidence and learning lessons as we go forward about effects and side effects,’ he told CNN.
Echoing Dr Holtgrave’s sentiments during CNN’s round table, Food and Drug Administration (FDA) Commissioner Dr Stephen Hahn said: ‘Obviously you need to wait for the entire cohort of individuals to have been treated with the complete course of treatment to get a full read on that.’
So far, the researchers have only revealed a hint at comparative survival rates, but the full study will also detail differing hospital stay lengths and whether patients treated or not treated with hydroxychloroquine had to be put in ICUs on ventilators, according to CNN.
FDA WARNS AGAINST USING HYDROXYCHLOROQUINE FOR CORONAVIRUS PATIENTS OUTSIDE OF HOSPITALS BECAUSE IT CAN CAUSE HEART PROBLEMS
By Mary Kekatos for DailyMail.com
The US Food and Drug Administration (FDA) has warned against using the anti-malaria drug hydroxychloroquine on coronavirus patients outside of hospital settings or clinical trials.
President Donald Trump has hailed the drug, which also is used to treat arthritis and lupus, as a ‘game-changer’ for treating COVID-19, the disease caused by the virus.
The federal health agency said it was issuing the warning after several reports of abnormal heart rhythms and rapid heart rates in patients who took the medication.
‘The FDA is aware of reports of serious heart rhythm problems in patients with COVID-19 treated with hydroxychloroquine or chloroquine, often in combination with azithromycin,’ the FDA wrote in a statement issued on Friday.
‘We are also aware of increased use of these medicines through outpatient prescriptions. Therefore, we would like to remind health care professionals and patients of the known risks associated with both hydroxychloroquine and chloroquine.’
The FDA issued a statement warning doctors against using hydroxychloroquine (pictured) on coronavirus patients outside of hospital settings or clinical trials
The agency said hydroxychloroquine can still be used in clinical trials or in some hospitalized patients.
It’s not immediately clear if any trials are in progress or planned trials will be halted based on the new guidance.
President Trump was among the first to wax lyrical about the possible benefits of hydroxychloroquine for coronavirus patients last month.
‘This would be a gift from heaven, this would be a gift from God if it works,’ he said during a press conference. ‘We are going to pray to God that it does work.’
He then repeated the claims on Twitter.
‘HYDROXYCHLOROQUINE & AZITHROMYCIN, taken together, have a real chance to be one of the biggest game changers in the history of medicine. The FDA has moved mountains – Thank You! Hopefully they will BOTH (H works better with A, International Journal of Antimicrobial Agents),’ he wrote in March.
President Donald Trump has touted the drug in as a potential ‘game-changer’ for treating coronavirus. Pictured: Trump during the White House coronavirus daily briefing, April 23
The study Trump refers to comes from Marseille, France, in which 30 patients were treated with hydroxychloroquine for 10 days combined with azithromycin, an antibiotic.
Although very small, the study ‘showed a significant reduction of the viral carriage’ after the six days and ‘much lower average carrying duration’ compared to patients who received other treatments.
One week later, the FDA issued an emergency use authorization for the drug, saying it could be used in hospitalized coronavirus patients with severe disease.
Several weeks later, the French study’s publisher said the paper ‘did not meet its standards’ because it excluded data on patients who did not respond well to the treatment.
Since then, much of the initial excitement surround hydroxychloroquine has died down.
In one study from the National Institutes of Health, 28 percent of US veterans with coronavirus who were treated with hydroxychloroquine died of the infection.
About 22 percent of those getting the anti-malaria drug plus antibiotic azithromycin died as well.
The FDA made its warning after several reports of abnormal heart rhythms and rapid heart rates in patients who took the medication. Pictured: Medics prepared to intubate a patient with COVID-19 symptoms at home
Additionally, the family of a New York woman with symptoms of COVID-19 told NBC News she died after her doctor prescribed her a combination of hydroxychloroquine and azithromycin.
The family says the physician did not confirm she had the virus nor test for heart problems before prescribing the drug.
And, earlier this month, the Centers for Disease Control and Prevention (CDC) removed highly unusual guidance from its website informing doctors on how to prescribe hydroxychlorquine.
Initially, the CDC webpage had read: ‘Although optimal dosing and duration of hydroxychloroquine for treatment of COVID-19 are unknown, some US clinicians have reported anecdotally.’
Now the website no longer includes that information. Instead, its first sentence says: ‘There are no drugs or other therapeutics approved by the US Food and Drug Administration to prevent or treat COVID-19.’
Source: Daily Mail | Health News