Up to 10,000 NHS workers will be given anti-malaria drug hydroxychloroquine to see if it can protect them against the coronavirus in a new trial.
US President Donald Trump earlier this week announced he was taking the drug as a prophylaxis, despite there being no proof it works in this way.
And the evidence on whether it can even treat COVID-19 – the disease caused by the coronavirus – is mixed.
British researchers believe hydroxychloroquine’s ‘best chance’ of working is if it used in prevention, which is exactly how it is used against malaria.
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.
More than 40,000 frontline workers from around the world will take part in a trial to see if hydroxychloroquine, the anti-malaria drug touted by Donald Trump as a ‘game changer,’ can really help fight coronavirs
Professor Sir Nicholas White said a randomised clinical trial is the best way to find out if chloroquine or hydroxychloroquine are beneficial
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.
‘We really do not know if chloroquine or hydroxychloroquine are beneficial or harmful against Covid-19,’ he said.
‘The best way to find out if they are effective in preventing Covid-19 is in a randomised clinical trial.’
It comes just days after the US president’s decision to take hydroxychloroquine was described as ‘a staggering, irresponsible act that could very well also amount to self-harm’ and there are fears his actions risk running down supplies of the drug for people with other conditions who need it.
Dr Stephen Griffin, associate professor in the school of medicine at the University of Leeds, also said those that follow Mr Trump’s example might not only endanger themselves, ‘but could also deprive patients with chronic autoimmune conditions of their much-needed medication’.
The price of hydroxychloroquine is said to have risen dramatically as the availability of the drug has reduced because of demand from those who believe it will prevent Covid-19.
Scientists say the drug has some ‘very serious’ side-effects and there is no evidence that it prevents or treats the disease.
But those running the MORU trial have said chloroquine and hydroxychloroquine ‘could reduce the chances’ of catching coronavirus amid fears of a second wave of infections.
The study’s lead UK investigator, Prof Martin Llewelyn of Brighton and Sussex School, said a ‘safe and effective vaccine may be a long way off’.
He added: ‘If drugs as well tolerated as chloroquine and hydroxychloroquine could reduce the chances of catching Covid-19 this would be incredibly valuable.’
Hydroxychloroquine is a prescription drug used for acute malaria and certain types of arthritis.
It can reduce inflammation, pain, and swelling – and is widely used to treat rheumatic diseases.
It is a derivative of chloroquine, which is also used to treat malaria.
The UK Government has said that chloroquine and hydroxychloroquine are not licensed to treat Covid-19 related symptoms or prevent infection.
It said the drugs should not be used outside ongoing clinical trials which have reached no conclusions over the safety and effectiveness of the medicine on coronavirus.
The first UK participants in the new trial can be enrolled from today at Brighton and Sussex University Hospitals and at Oxford’s John Radcliffe Hospital.
Further testing is expected at another four sites by the end of May, with 25 total locations opened across the UK before July and more planned around the globe.
The team aims to deliver results by the end of 2020.
Donald Trump has backed the anti-malaria drug, even telling reporters he has been taking it
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.