Hydroxychloroquine ‘raises the risk of death for coronavirus patients’
An anti-malaria drug backed by Donald Trump is not an effective Covid-19 treatment and raises the risk of death, a major study has today revealed.
In a massive blow to hopes of finding a cure and stopping the disease in its tracks, scientists found hydroxychloroquine offered ‘absolutely no benefit’.
Evidence on the medicine – subject of dozens of global trials and branded a ‘game-changer’ by the US President, who has admitted he is taking the drug to protect himself from catching the infection – has been mixed.
Promising results at the start of the pandemic sparked a flurry of studies, including on hospitalised patients in Britain and the US. But other trials have shown hydroxychloroquine isn’t the wonder drug doctors have longed for, proving it has no effect and may have deadly side effects.
Now research of nearly 100,000 Covid-19 patients, published in prestigious medical journal The Lancet, has cast further doubt over the drug’s efficacy.
As well as uncovering hydroxychloroquine had no benefit for coronavirus patients, results showed it raised the risk of death by up to 45 per cent. And Covid-19 patients taking the drug were up to five times more likely to develop a life-threatening arrhythmia – a known complication.
It comes as Oxford University researchers today announced they were looking to recruit 10,000 volunteers for the next two phases of trials of its experimental Covid-19 vaccine, considered one of the front-runners in the world’s race for a jab.
Pharmaceutical giant AstraZeneca has agreed to mass-manufacture the vaccine, in hope that millions of doses could be ready for September. The US government – which has invested $1billion (£806,00) in the project – has ordered 300million doses, while Britain has a deal for 100million.
In a massive blow to hopes of finding a cure and stopping the disease in its tracks, scientists found hydroxychloroquine offered ‘absolutely no benefit’
Evidence on the medicine – subject of dozens of global trials and branded a ‘game-changer’ by the US President – has been mixed
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WHY IS IT CONTROVERSIAL?
Hydroxychloroquine – branded as Plaquenil – is a cheap drug that has been used to prevent malaria and treat lupus and rheumatoid arthritis for decades.
But no evidence currently exists to show the drug can prevent patients being struck down with COVID-19, the disease caused by the coronavirus.
Scientists also warn there is no proof hydroxychloroquine, which was touted as a wonder drug by Donald Trump, can even treat COVID-19.
Hope was sparked early on in the crisis when a French study suggested the drug could have both antiviral and anti-inflammatory effects.
It triggered a flurry of research across the world, an endorsement from Trump and emergency authorization from US regulators.
But other research has dealt a blow to the drug, with one Chinese trial last month finding it did not speed up the recovery of COVID-19 patients.
And New York researchers last week said patients got no benefits whether they took just the drug or paired it with the antibiotic azithromycin.
Leading doctors have warned the drug can cause severe side effects, and can even throw off the process that makes the heart beat in time.
One trial in Brazil was stopped short because so many of the enrolled coronavirus patients given the drug developed these arrhythmias (abnormal heartbeats).
According to WebMD, side effects may include:
- Nausea, vomiting, loss of appetite, diarrhea, dizziness, or headache
- Slow heartbeat, symptoms of heart failure (such as shortness of breath, swelling ankles/feet, unusual tiredness, unusual/sudden weight gain)
- Mental/mood changes (such as anxiety, depression, rare thoughts of suicide, hallucinations)
- Hearing changes (such as ringing in the ears, hearing loss), easy bruising/bleeding
- Signs of infection or liver disease
- Muscle weakness, unwanted/uncontrolled movements (including tongue/face twitching), hair loss, hair/skin color changes
- Low blood sugar, severe dizziness, fainting, fast/irregular heartbeat, seizures.
Leading scientists today described the study – the latest in a string of research that has uncovered risks – as one of the ‘better ones’.
Experts at Brigham and Women’s Hospital in Boston, Massachusetts, analysed data from 96,032 hospitalised Covid-19 patients spanning six continents.
Around 5,000 of the infected were either given hydroxychloroquine or its derivative chloroquine.
Another 10,000 were given hydroxychloroquine or chloroquine alongside two other promising drugs, antibiotics azithromycin or clarithromycin.
Data from those four groups was then compared against a control sample of 81,000 Covid-19 patients, who were given other medications.
Analysis showed one in 11 patients in the control group died in hospital – at a rate of 9.3 per cent.
In comparison, 18 per cent of patients given hydroxychloroquine succumbed to the illness. The rate was 16 per cent among the chloroquine group.
When the two drugs were used in combination with one of the antibiotics, the death rate rose to almost a quarter of patients (23.8 per cent).
Researchers cautioned that some of the difference in the rates of mortality was due to underlying differences between which patients received the treatment.
Many of the sickest patients – whose risk of dying is higher – are given the drugs as a last-ditch resort.
But when other factors known to raise the risk of death were included – such as age, race, BMI and co-morbidities – the drugs still increased the risk of dying by between 34 and 45 per cent.
Lead author Dr Mandeep Mehra said: ‘This is the first large scale study to find statistically robust evidence that treatment with chloroquine or hydroxychloroquine does not benefit patients with Covid-19.
‘Instead, our findings suggest it may be associated with an increased risk of serious heart problems and increased risk of death.
‘Randomised clinical trials are essential to confirm any harms or benefits associated with these agents.
‘In the meantime, we suggest these drugs should not be used as treatments for Covid-19 outside of clinical trials.’
Professor Stephen Evans, an expert on drugs and disease outbreaks, at the London School of Hygiene and Tropical Medicine, called the study ‘interesting’.
TRUMP SAYS HE WILL FINISH HIS MALARIA PILLS WITHIN DAYS
President Donald Trump has claimed he will finish his prescription for a controversial drug in a bid to prevent coronavirus in the next two days.
Trump told journalists earlier this week that he had been taking the malaria pill hydroxychloroquine – which he has previously hailed as a ‘gift from God’ – every day to stave off coronavirius.
On Tuesday the 73-year-old told reporters that: ‘I think the regimen finishes in a day or two. I think it’s two days.’
The news the President was taking the drug came despite warnings from his own government that it should only be administered for coronavirus or in a hospital or research settings because of potentially fatal side effects.
He said: ‘I started taking it, because I think it’s good. I’ve heard a lot of good stories. Frontline workers take it, a lot of doctors take it, I take it.
‘I’m not going to get hurt by it, it’s been around for 40 years for malaria, for lupus. I’m taking the two – the zinc and the hydroxyl. So far I seem to be okay.’
Despite his comments, the drug has the potential to cause significant side effects in some patients and numerous studied have shown it is ineffective in combating coronavirus.
But he added: ‘The main findings are definitely not good for any of these four drug treatment groups.
‘It can be stated with some confidence that it is unlikely the [ongoing] randomised trials will find substantial benefit to these drugs.
‘It is clear that the drugs should not be given for treatment of Covid-19 other than in the context of a randomised trial.
‘It might even be said to go on giving them other than in a trial is unethical, given this evidence that is not yet contradicted by other available evidence.’
The study adds to past research that showed taking hydroxychloroquine could raise the risk of someone developing an abnormal heartbeat.
Scientists in the US and France last month found 90 per cent of critically-ill COVID-19 patients given hydroxychloroquine developed heart arrhythmias.
An arrhytmia is an abnormal heartbeat rhythm in which the heart beats too slow, too fast or irregularly.
It is relatively common, affecting around two million people per year in the UK, but can increase the risk of life-threatening events such as stroke or cardiac arrest.
Massachusetts General Hospital researchers monitored 90 patients in intensive care units, while University of Lyon academics analysed 40 patients.
Both uncovered similar results in JAMA Cardiology, after looking at the QT intervals – the time between the heart’s ventricular muscles contracting and then relaxing.
When this interval becomes too long, the patient has developed a dangerous form of heart arrhythmia, called atrial fibrillation.
Responding to today’s study by Brigham and Women’s Hospital, Professor Babak Javid, a consultant in infectious diseases at Cambridge University Hospitals, said the drugs had ‘absolutely no benefit’.
He added: ‘It (the study) certainly casts a great deal of doubt whether these agents are effective in the setting in which they are currently being used.’
But Professor Javid also warned the researchers did not have data for when patients began taking the drugs.
He said: ‘We know that anti-virals for Covid-19 are more likely to be effective given early in the disease process.
‘Since many of the patients were severely ill, it’s possible that treatment was started fairly late.’
President Trump sparked fury earlier this week when announced he was taking the drug as a prophylaxis, despite there being no proof it works in this way.
But British researchers believe hydroxychloroquine’s ‘best chance’ of working is if it used in prevention, which is exactly how it is used against malaria.
Up to 10,000 NHS workers will be given the drug to see if it can protect them against the coronavirus in a new international trial.
The trial will involve healthcare workers who come into direct contact with Covid-19 patients. Results are expected by the end of the year.
Hospitals in Brighton and Oxford will be among the first to be involved in the global study, which will also enroll volunteers in Europe, Africa, Asia and South America.
The TRUTH about hydroxychloroquine: Cheap malaria drug being trialled to treat COVID-19 has sparked hopes – but evidence shows it may NOT help after all and can even cause severe heart problems
INFECTED PATIENTS ‘GET NO BENEFIT FROM TAKING HYDROXYCHLOROQUINE’
Researchers funded by the National Institutes of Health looked at data from 1,438 COVID-19 patients across 25 hospitals in New York.
The study, published in JAMA last month, was observational and looked at the outcomes of patients given different drug combinations.
About 25 per cent of patients who received hydroxychloroquine and azithromycin – another promising coronavirus drug – died.
In comparison, the rate was 20 per cent for those only given hydroxychloroquine alone and was 10 per cent for those on azithromycin.
90% OF CRITICAL PATIENTS GIVEN THE DRUG DEVELOPED ARRHYTHMIAS
Scientists in the US and France last month found 90 per cent of critically-ill COVID-19 patients given hydroxychloroquine developed heart arrhythmias.
An arrhytmia is an abnormal heartbeat rhythm, which could be that the heart beats too slow, too fast or irregularly.
It is relatively common, affecting around two million people per year in the UK, but can increase the risk of life-threatening events such as stroke or cardiac arrest.
Massachusetts General Hospital researchers monitored 90 patients in intensive care units, while University of Lyon academics analysed 40 patients.
Both uncovered similar results in JAMA Cardiology, after looking at the QT intervals – the time between the heart’s ventricular muscles contracting and then relaxing.
When this interval becomes too long, the patient has developed a dangerous form of heart arrhythmia, called atrial fibrillation.
HYDROXYCHLOROQUINE MAY IMPAIR ABILITY OF IMMUNE SYSTEMS
Hydroxychlorouquine may impair the ability of patients’ immune systems to fight off the infection, a review suggested at the start of April.
Harvard scientists analysed 10 studies as well as anecdotal reports from doctors that suggested the drug could help coronavirus patient.
The review found many of the clinical trials were poorly conducted and anecdotal reports carried little weight.
HYDROXYCHLOROQUINE DOES NOT SPEED UP RECOVERY
The antimalarial drug hydroxychloroquine did not speed up coronavirus patients’ recovery in a trial in China, scientists revealed in April.
In a disappointing blow for the promising drug, doctors said it did not work as a cure.
Patients who were taking it suffered fewer symptoms than others who were treated alongside them without the medication but their recovery time was the same.
They had tested hydroxychloroquine on 75 COVID-19 patients in hospitals and compared their illnesses to 75 patients who didn’t receive the drug.
BRAZIL TRIAL STOPPED EARLY BECAUSE OF HEART PROBLEMS
A clinical trial in Brazil had to be stopped early, it was revealed last month, because patients developed heart problems.
The Brazilian study, taking place in the Amazonian city of Manaus, had planned to enroll 440 severely ill COVID-19 patients to test two doses of chloroquine.
But researchers reported their results and called a halt to the experiment after only 81 people had received the high-dose treatment which gave them 1,200mg per day.
One in four of the patients had developed heart rhythm problems and early data suggested death rates were higher among those patients.
MALARIA DRUG DOES IMPROVE SURVIVAL ODDS, PHYSICIANS CLAIM
Hydroxychloroquine has improved the survival and recovery odds for about 90 per cent of patients treated, a physicians group claimed.
The Association of American Physicians and Surgeons (AAPS) presented data on 2,333 patients treated with hydroxychloroquine.
Results showed 91.6 per cent of those who got the controversial drug fared better after treatment, it was reported at the end of April.
COMBINING DRUG WITH DIET SUPPLEMENT COULD WORK BETTER
Combining hydroxychloroquine with the dietary supplement zinc could create a more effective treatment for coronavirus patients, a study suggested last week.
Researchers found taking the drugs together, along with the antibiotic azithromycin, increased patient’s chances of being discharged and decreased their risk of dying.
It did not, however, change the average time patients spent in hospital, how long they spent on a ventilator or the total amount of oxygen required.
The team, from New York University Grossman School of Medicine, says the findings are encouraging but that more studies are needed.
HYDROXYCHLOROQUINE COULD HELP TREAT PATIENTS, STUDY SAYS
French researchers last month found hydroxychloroquine could treat coronavirus patients, sparking hope of a cure.
Thirty 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 results showed patients had a ‘much lower average carrying duration’ compared to patients who received other treatments.
Several weeks later, the 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.