Experts have no idea if Regeneron's experimental Covid-19 drug given to Donald Trump really does work and insist it could still turn out to be useless

 

• US President claimed he was cured of coronavirus by the experimental drug
• Scientists said it was 'irresponsible' as there's no proof it works against Covid
• Mr Trump was on a host of other drugs which may have helped, experts said 

Experts have slammed Donald Trump's 'irresponsible' claim that he was cured of coronavirus by an experimental drug made by the US pharmaceutical firm Regeneron.

The President praised the experimental antibody medication, called REGN-COV2, in a rambling video outside of the White House Rose Garden yesterday. 

Mr Trump — who was released from his four-day stint at the Walter Reed Medical Center on Monday — said he was cured of his illness the same day he was given the drug and has now promised to give it out for free to every American in hospital with severe Covid-19.

Regeneron hasn't publicly stated how much it will cost, but similar therapies that use antibodies - proteins produced by the body which fight off diseases - to treat conditions such as cancer can cost tens of thousands of dollars per patient. 

But leading scientists have urged Mr Trump to squeeze the brakes on his enthusiasm because there is no proof yet that it works and won't cause adverse side effects.

Professor Jake Scott, an infectious disease expert at Stanford University, said: 'I think it’s irresponsible to claim that the Regeneron [drug] made any difference at all, since it was used outside of a trial. 

'Proper research is potentially compromised by such premature conclusions that are being amplified by people like him on Twitter.' 

Professor Paul Hunter, an epidemiologist at the University of East Anglia in the UK, pointed out that Mr Trump was on a cocktail of other drugs which may have helped him recover.

He was also receiving dexamethasone — a cheap steroid shown to reduce death in the most severely ill patients — and remdesivir, an antiviral medication that has shown promise in studies but has not yet been scientifically proven to work.

Professor Hunter told MailOnline: 'It [Regeneron's antibody treatment] is a potentially useful drug. But he [Trump] was on so many different drugs that you don't know which one actually made the difference. 

'Another thing is most people recover from Covid-19 naturally, even people in his age bracket — often within about a week. So it could be that he just naturally got better in a week.'

Mr Trump was admitted to hospital last Friday and is thought to have contracted the coronavirus sometime in the middle of the week — which would appear to back up Professor Hunter's theory.  

Some people can have an allergic reaction to antibody-based treatments that causes their blood pressure to drop to potentially dangerous levels, although this is very rare, according to Professor Hunter. 

REGN-COV2 is currently being trialled globally, including in UK hospitals, where at least 2,000 patients will receive it. The Recovery study, co-ordinated by the University of Oxford, will assess the impact of giving patients the drug alongside usual standard care, to see if it lessens the severity of Covid-19 and can reduce deaths .

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'I think this was a blessing from god that I caught it,' President Donald Trump said in a video from the Rose Garden after not being seen by the public for more than 24 hours during his Covid-19 recovery

Questions have also been swirling about Mr Trump's ties to Regeneron's billionaire CEO after the US President gushed over the company.

Shares of Regeneron surged by 7 per cent on Monday when Mr Trump first mentioned the drug after leaving the Walter Reed Medical Centre. 

But it was revealed that Regeneron CEO Dr Leonard Schleifer is a member at Trump's golf club in Winchester, New York.

The company also received $450million (£340m) in Government funding in July as part of the Operation Warp Speed package to tackle Covid-19.

Mr Trump also recently owned shares in the company as recently as 2017, according to CNN.

Regeneron's drug uses monoclonal antibodies - proteins found in people who have survived Covid-19 that have been genetically modified in a lab. 

These substances are then injected into patients to help their immune systems fight off the viral infection in the early stages of their illness.

This is significant because, currently, there are no drugs on the market that prevent people from falling severely unwell with the disease.

The only medicines scientifically proven to have an effect are steroids that for people already on ventilators or with dangerously low oxygen levels. 

Monoclonal antibodies are already being used to treat tetanus, Ebola and diphtheria and rarely cause severe side effects.

Professor Hunter told MailOnline: 'The use of antibodies like this to treat viral infections is not new, although success rates very wildly from one to another. 

'Regeneron's drug certainly has potential, but the issue is you cant generalise –even if it has worked on the president, it doesn't mean it will work for everyone.

'To know if something is useful you need to have proper trials. So it may well be a really valuable drug but you have to wait for properly conducted randomised trials to see if it's really good as they say.

'But it wouldn’t be the first time a small trial has suggested something really good but proved to be useless.' 

Professor Hunter was referring to small and early trials of the malaria drug hydroxychloroquine, which appeared to suggest it could treat people with coronavirus.

Mr Trump hailed the medicine as a 'game changer' at the time despite no large scale trials backing up his claim.

Then a clinical study in the UK found it categorically did not have any effect on people with the virus and doctors around the world were urged to stop using it. But other studies have suggested it may have a benefit.

Antibodies are proteins the immune system makes when someone becomes infected with a virus, such as the pathogen that causes Covid-19.

But it can take weeks for them to form after being infected or having a vaccine, which is often too late as the virus has already multiplied in the body.

For some people - particularly the elderly and those with weakened immune systems - their bodies struggle to muster up enough antibodies to fight the disease.

Regeneron's drug - called REGN-COV2 - is a combination of two lab-made versions of antibodies that help block the coronavirus from entering cells.  

One of the antibodies in the 'cocktail' is based on an antibody that mice produce in response to coronavirus, while the other is based on an antibody isolated from the one of the first US Covid-19 patients. 

The hope is that the treatment drives down viral load, keeping it from overrunning the body and sending the immune system haywire, and preventing the infection from becoming severe. 

REGN-COV2 is still in early trial phases, but the first data from its clinical trial found that it dramatically lowered viral load within a week and cut recovery time in half in patients that weren't sick enough to be hospitalized. 

Regeneron has not yet studied the drug in severely ill patients. The main concern is these types of treatment occasionally trigger 'antibody-dependent enhancement,' which means the intended therapeutic actually helps the virus invade cells.

So far, the trials don't suggest that REGN-COV2 is causing this phenomenon. 

Antibody treatments can also cause allergic reactions including anaphylaxis, as well as fever, chills, nausea, diarrhea, weakness, headache and low blood pressure. 

Other, similar, monoclonal antibody treatments for Covid-19 are being created and trialled by scientists around the world.

This week, British pharmaceutical giant GlaxoSmithKline moved its antibody drug -  known as Vir-7831 - into late stage trials. 

An early trial on 20 patients in the US suggested the new antibody medicine was safe and did not cause any adverse health effects.

Now the study will expand across North America, South America and Europe and aim to recruit nearly 1,500 volunteers to see if the drug can prevent serious illness. 

Cambridge-based drugmaker AstraZeneca is also trialling its three-minute infusion of antibodies, which works in the same way.

Results from both studies are expected late next year, with researchers hoping to get them rolled out by 2022 if they work. 

The hysteria around Regeneron came after Mr Trump released a video of himself in the White House Rose Garden, where he called getting coronavirus a 'blessing from God' because it led him to discover the the new antibody drug.

'I think this was a blessing from god that I caught it. This was a blessing in disguise,' Trump said.

'I heard about this drug. I said let me take it. It was my suggestion,' he said. Then he proclaimed himself 'cured' and said he wanted every American to get the type of treatment he got.   

Trump kicked off the nearly-five minute video with an odd introduction that did not state his name.

'Hi, perhaps you recognize me, it's your favorite president,' he said. It appeared from the makeup he was wearing a liberal application of makeup on his face.

'And I'm standing in front of the Oval Office at the White House, which is always an exciting place to be,' he continued.

'I got back a day ago from Walter Reed Medical Center, I spent four days there, and didn't have to, I could have stayed at the White House but the doctors said because you're president let's do it, I said fine,' Trump said. 

'You tell me what to do and I'm going to do it. These are great professionals,' Trump said. He also went on a tangent where he praised police and firefighters.

He then praised the experimental antibody cocktail from Regeneron he took, calling it a 'cure.' 

'But I spent four days there and I went in, I wasn't feeling so hot and within a very short period of time they gave me Regeneron, it's called Regeneron, and other things too, but I think this was the key. But they gave me Regeneron and it was like unbelievable, I felt good immediately, I felt as good three days ago as I do now. So I just want to say we have Regeneron, we have a very similar drug from Eli Lilly. And they're coming out and we're trying to get them on an emergency basis,' Trump said.