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More than 5,000 Britons have volunteered to take part in the world's biggest COVID-19 drug trial

More than 5,000 people in Britain have volunteered to take part in a pioneering drug trial in search of a treatment for the currently incurable COVID-19. 

The Recovery Trial, conducted by Oxford University, recruited the participants — all of whom are COVID-19 patients already in hospital — at more than 160 NHS hospitals. 

Participants will receive one of four drugs currently on the market — including one that is used to treat HIV and the anti-malaria drug touted by Donald Trump, known as hydroxychloroquine.

It is the world’s biggest trial of drugs to treat the coronavirus, which has killed more than 13,000 people in Britain and almost 150,000 globally.   

This is significantly more than similar clinical trials in the US and Europe, which have just a few hundred participants.

Currently, experts are divided on which drugs offer the best protection against the disease. 

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It is the world's biggest trial of drugs to treat the coronavirus, which has killed more than 13,000 people in Britain and almost 150,000 globally. it will be run by Oxford University and includes four potential treatments, of which one is hydroxychloroquine

 It is the world’s biggest trial of drugs to treat the coronavirus, which has killed more than 13,000 people in Britain and almost 150,000 globally. it will be run by Oxford University and includes four potential treatments, of which one is hydroxychloroquine

WHAT DRUGS WILL FEATURE IN THE RECOVERY TRIAL? 

A range of potential treatments have been suggested for COVID-19 but nobody knows if any of them will turn out to be more effective in helping people recover than the usual standard of hospital care which all patients will receive.

The RECOVERY Trial will begin by testing some of these suggested treatments: 

  • Lopinavir-Ritonavir (commonly used to treat HIV) 
  • Low-dose Dexamethasone (a type of steroid, which is used in a range of conditions typically to reduce inflammation)
  • Hydroxychloroquine (related to an anti-malarial drug) 
  • Azithromycin (a commonly used antibiotic)

Peter Horby, professor of emerging infectious diseases and global health at Oxford University, is leading the project and said: ‘This is by far the largest trial in the world.

‘We’re guessing some time in June we may get the results. 

‘If it is really clear that there are benefits, an answer will be available quicker.’ 

However, professor Horby cautioned against thinking the trial will provide an instant cure.

He told The Guardian: ‘We haven’t got anything like a magic bullet. 

‘I think we have to temper people’s expectations about these drugs. 

‘It’s possible some might have an effect, but it’s likely to be modest. 

‘I think what we’ll be looking at in terms of making a significant impact will be moving on to combinations once we know of things that work. 

‘If we combine antiviral and anti-inflammatory drugs, they might have a bigger impact.’

The huge number of volunteers comes after leading medical scientists called for Britons to take part in the trials at the start of the month. 

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

This call to arms included the Recovery (Randomised Evaluation of COVID-19 Therapy) trial, as well as the Principle trial, for high-risk patients in primary care and REMAP-CAP, for critically ill patients.

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.

‘The faster that patients are recruited, the sooner we will get reliable results,’ the letter stated.   

The Recovery Trial will start by investigating four pre-existing drugs, including the highly-touted hydroxychloroquinem, which was voted as the best coronavirus drug currently available in an international poll of thousands of doctors. 

The other drugs being looked at as a treatment for COVID-19 include a combination of Lopinavir and Ritonavir (known by the brand name Kaletra), which is used to treat HIV; low-dose Dexamethasone,a steroid used to reduce inflammation; and azithromycin, a commonly used antibiotic. 

Controversial evidence claims a combination of hydroxychloroquinem and azithromycin is effective against coronavirus. 

Donald Trump gave this theory life when he tweeted saying it is ‘one of the biggest game-changers in the history of medicine’. 

The combination has also received tentative support from French President Emmanuel Macron, who called for further trials into the treatment’s efficacy. 

He visited the lab of prominent French doctor Didier Raoult who claimed the combination is a cure for the killer virus. 

Recovery will look at the drugs separately and gauge how effective they are as independent treatments. 

If they show promise it is possible a combined trial will be set up further down the line, the scientists claim. 

According to the Guardian, a drug used to treat rheumatoid arthritis is also set to be included in the RECOVERY trial. 

Called tocilizumab, it is an interleukin 6 antagonist and combats the fall-out when the immune system goes into overdrive, as can happen in severe COVID-19 cases.  

Other ongoing trials in the UK include the REMAP-CAP trial, which is an international effort.

It includes more than 50 research teams around the world and 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 also be tested at these sites. 

The Principle trial is another onging project and 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. 

The University of Oxford is also leading the charge in the search for a vaccination, and is looking for more than 500 people aged between 18 and 55 to test the effectiveness of the vaccine, dubbed ChAdOx1 nCoV-19. 

The potentially life-saving injection is already in production but will not be ready ‘for some weeks’, the institution said in a statement. 

Those selected for the study will be split into two groups, and given either the vaccine itself or a dummy jab. The patient will not know which one they are given. 

Manufacture of the vaccine is occurring at the university itself.   

Work on the vaccine started in January when the first details of the SARS-Cov-2 virus were reported to the World Health Organization. 

It has been fast-tracked through development and flown through clinical trials and preliminary animal tests. 

Professor Adrian Hill, Director of the Jenner Institute at the University of Oxford, said: ‘The Oxford team had exceptional experience of a rapid vaccine response, such as to the Ebola outbreak in West Africa in 2014. 

‘This is an even greater challenge. Vaccines are being designed from scratch and progressed at an unprecedented rate. 

‘The upcoming trial will be critical for assessing the feasibility of vaccination against COVID-19 and could lead to early deployment.’  

The trial has full scientific and ethical approval but scientists acknowledge the accelerated pace does pose risks. 

However, these are likely to be outweighed by the benefits of creating an effective vaccine to the novel coronavirus which has infected more than half a million people. 

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

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, 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.

A separate Chinese study published in the New England Journal of Medicine found that the lopinavir-ritonavir combination did not improve survival or speed recovery of COVID-19 patients.

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  








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