United Kingdom

UK's top medical experts issue plea for more volunteers to take part in coronavirus drug trials

The medical experts spearheading Britain's fight against coronavirus have issued a plea for more more infected patients to take part in three major clinical drug trials. 

NHS England medical director Professor Stephen Powis and the UK's chief medical officers penned an open letter to doctors urging them to enroll more volunteers.  

There are three main trials being conducted in the UK to find an effective treatment for the incurable virus, which has killed 3,605 people in the UK.

They include the Principle trial, for high-risk patients in primary care, Recovery, for COVID-19 patients already in hospital, and REMAP-CAP, for critically ill patients.

Researchers behind the trials are testing the effect of a number of treatment options, including a drug used to treat HIV and the malaria medication hydroxychloroquine. 

'The faster that patients are recruited, the sooner we will get reliable results,' the letter says.

Hydroxychloroquine was today voted the best coronavirus drug currently available in an international poll of thousands of doctors.  

Britain's Deputy Chief Medical Officer, Professor Jonathan Van-Tam at Number 10's press conference tonight

Chief medical officer Chris Whitty and NHS England medical director Professor Stephen Powis said in the letter: 'The faster that patients are recruited, the sooner we will get reliable results'

Hydroxychloroquine - one of the drugs being trialled - was today voted the best coronavirus drug currently available in an international poll of thousands of doctors

WHAT ARE THE THREE MAIN CORONAVIRUS TRIALS IN THE UK?

Principle 

The Principle trial is studying people aged 50 to 64 who have COVID-19 symptoms and a chronic health condition such as heart disease, asthma or cancer. 

It is unclear how many patients are taking part. 

It is also open to those aged 65 or over, with or without other illnesses.

The first drug that will be trialled is hydroxychloroquine, sold as Plaquenil. Other potential treatments will be used if they show promise in pre-clinical studies.

The study is being run at the Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC) in Surrey.

It will last until March next year.

Recovery

The Randomised Evaluation of COV-id19 thERapY (RECOVERY) trial is being run by the University of Oxford. 

It will test the HIV drug lopinavir/ritonavir, marketed as Kaletra and Aluvia, hydroxychloroquine, a malaria medication sold as Plaquenil, and dexamethasone, a type of steroid use in a range of conditions to reduce inflammation.

Almost 1,000 patients from 132 different hospitals have been already recruited in just 15 days.

Thousands more are expected to join the trial in the coming weeks, making it the largest randomised controlled trial of potential COVID-19 treatments in the world.

Definitive results on whether the treatments are safe and effective are expected within months and, if positive, they could potentially benefit hundreds of thousands of people worldwide. 

REMAP-CAP

The REMAP-CAP trial is an international effort, with more than 50 research teams around the world taking part. 

It is looking specifically at patients who develop community-acquired pneumonia (CAP) as a result of viral infections.   

The study will test 16 drugs, including  hydroxychloroquine, lopinavir/ritonavir and interferon beta, which have all shown promise in pre-clinical trials.

Between 2,000 and 4,000 patients will be enrolled.

Chief medical officer Professor Chris Whitty and his deputy Professor Jonathan Van-Tam continue: 'As yet, there are no proven treatments for COVID-19. We need to gather reliable evidence through clinical trials. 

'Using international evidence and UK expertise the most promising potential treatments, at this stage, have been identified and the UK is running national clinical trials to gather evidence across the whole disease spectrum.'

The letter adds that using treatments without taking part in a trial would be a 'wasted opportunity'. 

The Randomised Evaluation of COV-id19 thERapY (RECOVERY) trial is being run by the University of Oxford. 

It will test the HIV drug lopinavir/ritonavir, marketed as Kaletra and Aluvia, hydroxychloroquine, a malaria medication sold as Plaquenil, and dexamethasone, a type of steroid use in a range of conditions to reduce inflammation.

Almost 1,000 patients from 132 different hospitals have been already recruited in just 15 days.

Thousands more are expected to join the trial in the coming weeks, making it the largest randomised controlled trial of potential COVID-19 treatments in the world.

Definitive results on whether the treatments are safe and effective are expected within months and, if positive, they could potentially benefit hundreds of thousands of people worldwide. 

The REMAP-CAP trial is an international effort, with more than 50 research teams around the world taking part. 

It is looking specifically at patients who develop community-acquired pneumonia (CAP) as a result of viral infections.   

The study will test 16 drugs, including hydroxychloroquine, lopinavir/ritonavir and interferon beta, which have all shown promise in pre-clinical trials.  

New potential treatments specific to COVID-19 will be tested at these sites. 

The Principle trial is studying people aged 50 to 64 who have COVID-19 symptoms and a chronic health condition such as heart disease, asthma or cancer.  It is also open to those aged 65 or over, with or without other illnesses.

The first drug that will be trialled is hydroxychloroquine, sold as Plaquenil. Other potential treatments will be used if they show promise in pre-clinical studies. 

The study is being run at the Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC) in Surrey. It will last until March next year. 

It comes after the number of people admitted to hospital with coronavirus in the worst-hit part of the UK fell for the first time.

London, which has been at the heart of the pandemic in the UK, saw new admissions fall below 4,000 again on Wednesday, according to Government data released tonight.

There were also falls in the Midlands, East Midlands and North West as the death toll rose sharply by 684 today to take the total number of tragic fatalities so far to 3,605. 

WHICH DRUGS ARE BEING TESTED IN THE THREE MAJOR TRIALS? 

Hydroxychloroquine 

The malaria drug chloroquine is the best coronavirus treatment currently available, according to an international poll of thousands of doctors. Pictured: hydroxychloroquine, a version of it, is prescribed in the US under the brand name Plaquenil

What are the brand versions of the drug?

Plaquenil.

What does it treat?

Malaria, lupus and rheumatoid arthritis. It is a less powerful and, by some experts' accounts, less toxic, version of chloroquine phosphate.

Who makes it and where has it already been tested?

Drug giant Sanofi carried out a study on 24 patients, which the French government described as 'promising'. 

French health officials are now planning on a larger trial of the drug, which is used on the NHS. 

What have studies shown?

Results from the French study showed three quarters of patients treated with the drug were cleared of the virus within six days. None of the placebo group were treated. 

How does it work?

It interferes with viral molecules replicating in red blood cells.

Is it being tested in the UK?

It is thought to be among 1,000 drugs being tested at Queens University Belfast. 

What are its side effects?  

Skin rashes, nausea, diarrhoea and headaches.

What do the experts think?

Chinese scientists investigating the other form of chloroquine penned a letter to a prestigious journal saying its 'less toxic' derivative may also help.

In the comment to Cell Discovery – owned by publisher Nature, they said it shares similar chemical structures and mechanisms.

The team of experts added: 'It is easy to conjure up the idea that hydroxychloroquine may be a potent candidate to treat infection by SARS-CoV-2.' 

Lopinavir/ritonavir, marketed under the brand names Kaletra and Aluvia, is an anti-HIV medicine

Lopinavir/ritonavir 

What are the brand versions of the drug?

Kaletra and Aluvia.

What does it treat? 

It is an anti-HIV medicine given to people living with the virus to prevent it developing into AIDS.

Who makes it?

Illinois-based manufacturer AbbVie donated free supplies of the drug to authorities in China, the US and Europe for tests.

What have studies shown? 

Chinese media reported that the drug was successfully used to cure patients with the coronavirus, but the reports have not been scientifically proven.

However, the authors noted they had enrolled a 'severely ill population' of patients.

In a clinical trial submission, scientists in South Korea said lab studies have: 'In vitro [laboratory] studies revealed that lopinavir/ritonavir [has] antiviral activity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).'

How does it work? 

It is a class of drug called a protease inhibitor, which essentially stick to an enzyme on a virus which is vital to the virus reproducing. 

By doing this it blocks the process the virus would normally use to clone itself and spread the infection further.  

Other drugs  

Shock-dependent hydrocortisone (sold under brand names Hydrocort, Alphosyl, Aquacort, Cortef, Cortenema, and SoluCortef)

Ceftriaxone (brand name Rocephin)

Moxifloxacin 

Piperacillin-tazobactam (brand name Tazocin)

Ceftaroline 

Amoxicillin-clavulanate

Macrolide (brand names Zithromax, Klacid, Erymax, Erythrocin, Erythroped and Erythroped A) 

Oseltamivir (brand name Tamiflu) 

Interferon-β1a

Anakinra  

Professor Jonathan Van-Tam, deputy chief medical officer for England, cautioned against reading too much into the data.

The 24-hour total  has risen by a record amount almost every day this week, with a five-fold increase in deaths in a week.

However at tonight's news conference Professor Jonathan Van-Tam, deputy chief medical officer for England, cautioned against reading too much into the data.

He said that overall the number of admissions was still rising. Asked about seeing any 'green shoots' in the battle against the virus he added: 'If you're asking me about the healthcare hospital admission data then I think it's too early to make any kind of interpretation such as that. 

'There will be day-to-day variations in the number of hospital admissions that occur as a feature of near-random chance.

'So one mustn't interpret the data, one needs to be patient and look for a long-term trend.' 

However, Prof Van-Tam said he 'absolutely sees green shoots' of hope over containing the spread of Covid-19, given the response to the social distancing measures.

He said: 'I absolutely see green shoots, I really do in terms of the massive change in public behaviour that has already taken place.

'If that continues for as long as the Government asks for it to continue then they really will be quite big green shoots in the end.'

Asked  when the peak of the epidemic is expected to be, he said: 'We don't know the answer to that yet.

'We've always said that we will know if our social distancing measures are working a few weeks after we've put them in place.'

He reiterated it was 'too soon to say', adding: 'It'll partly depend upon how well those social distancing measures are adhered to by every one of us.

'I hope it will be soon. We're going to watch very carefully to see when we've hit the peak and when we're starting to turn it but we will not take any premature actions.'

Addressing whether the NHS will have enough ventilators during the peak, given some fear they will not receive the critical care they need, Professor Van-Tam expressed confidence in equipment supplies.

He said: 'I can tell you I don't think we're anywhere close to that kind of scenario at the moment. We will watch it extremely closely and we will make decisions as we need to on a day-by-day basis.'

Malaria drug hydroxychloroquine is the most effective coronavirus treatment currently available, finds international poll of 6,000 doctors

The malaria drug hydroxychloroquine is the best coronavirus drug currently available, according to an international poll of thousands of doctors. 

Of 6,200 physicians surveyed from 30 countries, the majority (37 per cent) said it was the 'most effective therapy' for the virus.

But the World Health Organization (WHO) claims that 'there is no evidence' that any medicine 'can prevent or cure the disease'. 

With a spiralling crisis and no cure in sight, doctors in Europe, the US and China have been given licence to prescribe the promising drug to COVID-19 patients.

But the UK has prevented clinicians from dishing out hydroxychloroquine - a form of chloroquine - until clinical trials are completed. 

The malaria drug chloroquine is the best coronavirus treatment currently available, according to an international poll of thousands of doctors. Pictured: hydroxychloroquine, a version of it, is prescribed in the US under the brand name Plaquenil

Of 6,200 physicians surveyed from 30 countries, the majority (37 per cent) said hydroxychloroquine was the 'most effective therapy' for the virus

Chloroquine (CQ), branded as Aralen, and counterpart hydroxychloroquine (HCQ), known as Plaquenil, are well-established medicines.

They are also prescribed on the NHS to treat rheumatoid arthritis and lupus and have been used since the 1940s. 

The latest poll, conducted by Sermo - a 'virtual lounge' for doctors, found the tablets were most widely used for COVID-19 in Spain, where 72 per cent of physicians said they had prescribed them. 

WHICH COUNTRIES HAVE ALREADY APPROVED CHLOROQUINE TO TREAT PATIENTS? 

Medicine regulators in the US have approved the use of antimalarial drugs chloroquine and hydroxychloroquine in patients with severe cases of COVID-19.

Doctors across the States can now prescribe the medicines to patients who are critically ill with the virus.

They were granted emergency approval by the Food & Drug Administration (FDA) on March 30.

Doctors in Spain and Italy - the two worst-affected European countries -have already been told they can prescribe the drugs as a last resort.

In the UK, meanwhile, doctors have been instructed not to use the drugs, which can also treat rheumatoid arthritis and lupus, except in clinical trials.

The British Government has banned wholesalers from exporting the drugs to different countries, showing it is protecting the UK supply, but has not yet approved its widespread use because of a lack of evidence.

South Korea was also among one of the first countries to start using it, and there have been reports of doctors in the Netherlands giving it to COVID-19 patients. 

In France, a team led by Professor Didier Raoult at a hospital in Marseille reported last week that they had carried out a study of chloroquine on 36 COVID-19 patients.

The World Health Organization has launched a worldwide trial called SOLIDARITY, involving scientists in countries all over the globe, to test which drugs work well on COVID-19 patients - chloroquine and hydroxychloroquine are included in this. 

Fifty-three per cent of doctors in Italy said they had used the drugs to treat the killer virus, while in China it was 44 per cent.

Just 13 per cent of UK clinicians surveyed said they had prescribed chloroquine to coronavirus patients, presumably through private clinics. 

The poll did not state which other drugs were voted most effective in treating COVID-19. 

But it did note that the three most commonly prescribed treatments by doctors were analgesics (56 per cent), a type of painkiller, azithromycin (41 per cent), an antibiotic used for bacterial infections, and hydroxychloroquine (33 per cent).

Sermo chief executive Peter Kirk described the polling results as a 'treasure trove of global insights for policymakers'.

He added: 'Physicians should have more of a voice in how we deal with this pandemic and be able to quickly share information with one another and the world.'  

Around the world, countries are expanding access to chloroquine, a synthetic form of quinine, which comes from cinchona trees and has been used for centuries to treat malaria.  

They work against those conditions by dampening the body's immune response when it overreacts and could be beneficial for coronavirus patients in the same way. 

Early trials in China have shown they can reduce the severe effects of coronavirus, and doctors are even considering mass use of drugs as a ‘prophylactic’ to give to people who test positive for the virus but have yet to show symptoms.

Doctors across America can now prescribe CQ and HCQ as a last resort for critically ill COVID-19 sufferers. 

But it has not been licensed in the UK. 

A Department of Health and Social Care spokesperson said: 'Clinical trials are already underway in the UK to assess whether existing medicines such as hydroxychloroquine are suitable for treating COVID-19.

'Until we have clear, definitive evidence these treatments are safe and effective, they should only be used within a clinical trial.

'People should continue to follow NHS advice and stay at home, protect the NHS and save lives.'

Hydroxychloroquine appears to be safe, but its effectiveness for COVID-19 is still unknown. 

Both forms of the drug are thought to be among 1,000 medicines being tested against coronavirus in a lab as part of a Queens University Belfast study. 

Larger trials have been put in motion, including in the US, where one began in New York this week.

Italy is carrying out a trial on 2,000 people, while scientists are also awaiting the results from bigger trials in China. 

A European trial called Discovery will study four experimental therapies, including chloroquine, using 3,200 patients who have been hospitalised from the killer virus in the UK, Spain, Germany, France, Sweden and Luxembourg.

But Dr Ellie Cannon, an NHS GP and Mail on Sunday health columnist, said the drug was not a miracle cure.

She said: 'Please stop thinking anti malarial tablets are the magic bullet until they're proven to be the magic bullet.'

Speaking on LBC radio this week, Dr Cannon added: 'All the evidence is being weighed up about the treatments, we must always remember that these medications come with side effects and risks.

NHS GP Dr Ellie Cannon said she had 'a lot of requests' for antimalarials but that it was not safe for people to take it  

ARTHRITIS PATIENTS FACE MISSING OUT ON VITAL DRUGS IF THEY ARE DIVERTED TO FIGHT THE VIRUS 

Patients with arthritis, lupus and other autoimmune diseases could face missing out on vital drugs if they are diverted to the coronavirus cause, doctors warned yesterday. 

Experts writing in the BMJ journal Annals of the Rheumatic Diseases say there are only limited supplies of these drugs. 

The scientists, from Sapienza University in Rome, warn there are not enough supplies of antimalarials for them to be used on a mass scale without taking them away from existing autoimmune patients. 

The European League Against Rheumatism (EULAR) said use of these drugs to tackle Covid-19 could have serious implications for people with rheumatic diseases across Europe.

EULAR president Professor Iain McInnes, of the University of Glasgow, said: ‘EULAR is concerned that the diversion of drug supplies away from people with rheumatic and musculoskeletal diseases may compromise the health of this important and sizeable group of patients in Europe and beyond.

‘A balanced approach that meets the imperatives of the ongoing pandemic, but which also takes account of the needs of patients already taking these drugs is essential.’ 

'For example, these antimalarial medications are known to cause heart rhythm problems. We know they are very dangerous for people with liver and kidney problems.'  

Dr Cannon said she and pharmacists had been getting 'a lot of requests' for antimalarial prescriptions because people have heard of its potential to help treat COVID-19. 

She added: 'I think we are all looking for a cure, we're all looking for an answer for ourselves, for our vulnerable relatives. 

'But we have to be so careful about these hidden dangers in what seems to be a magic bullet. 

'There a lot of private people unfortunately profiteering and I think we are all vulnerable to these things at the moment.'

Last week, a man from Arizona died after drinking fish tank cleaner which contained a form of chloroquine intended to fight aquatic parasites - it was not safe for human consumption.

Professor Stephen Evans, of the London School of Hygiene and Tropical Medicine (LSHTM), previously told MailOnline: 'Using non-approved substances, even if the active ingredient in a medicine is in another non-medical product, it is dangerous to use it as if it were a medicine.

'From this tragic occurrence in the US it is clear that people will do foolish things in the belief that they are helping themselves.'

Patients with arthritis, lupus and other autoimmune diseases could face missing out on vital drugs if they are diverted to the coronavirus cause, doctors warned yesterday. 

Experts writing in the BMJ journal Annals of the Rheumatic Diseases say there are only limited supplies of these drugs. 

The scientists, from Sapienza University in Rome, warn there are not enough supplies of antimalarials for them to be used on a mass scale without taking them away from existing autoimmune patients. 

The European League Against Rheumatism (EULAR) said use of these drugs to tackle Covid-19 could have serious implications for people with rheumatic diseases across Europe.

EULAR president Professor Iain McInnes, of the University of Glasgow, said: ‘EULAR is concerned that the diversion of drug supplies away from people with rheumatic and musculoskeletal diseases may compromise the health of this important and sizeable group of patients in Europe and beyond.

‘A balanced approach that meets the imperatives of the ongoing pandemic, but which also takes account of the needs of patients already taking these drugs is essential.’ 

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