The “world’s largest randomised clinical trial” is already up and running in the UK, as part of the race to find effective treatments for Covid-19, the Department of Health (DHSC) has said.
The trial, which is being co-ordinated by researchers at the University of Oxford, has received £2.1 million of funding and is part of further investment into rapid research response during the ongoing pandemic.
It is one of three national trials which will cover each major stage of the disease – primary care, hospital care and critical care for the most seriously ill.
Results on whether the treatments are safe and effective are expected within months and could benefit hundreds of thousands of people worldwide if successful, the DHSC added.
Health Secretary Matt Hancock told a press conference on Friday that research on treatment for Covid-19 was “essential to our plan” for tackling the epidemic.
“We are bringing together some of the finest research minds in the country to design new trials and we’re delivering them at record pace,” he said.
“We have established three national clinical trials covering each major stage of the disease – primary care, hospital care and critical care for the most seriously ill.
“Just like the Nightingale hospital, one of these was put together in just nine days, which is breathtaking speed.”
The trials will look at the effectiveness of existing drugs and steroids, which may be repurposed to fight Covid-19, such as Lopinavir/Ritonavir, which is currently authorised as an anti-HIV medicine, and hydroxychloroquine, a treatment for malaria.
UPDATE on coronavirus (#COVID19) testing in the UK:— Department of Health and Social Care (@DHSCgovuk) April 3, 2020
As of 9am 3 April, a total of 173,784 people have been tested of which 38,168 tested positive.
As of 5pm on 2 April, of those hospitalised in the UK who tested positive for coronavirus, 3,605 have sadly died. pic.twitter.com/vmTosNMPyS
Mr Hancock said that an “expert therapeutics taskforce” had also been set up to search for and “shortlist other candidate medicines for trial”.
Deputy chief medical officer, Professor Jonathan Van-Tam, said that a lot of work on clinical trials has been going on “for weeks behind the scenes” and that it was important that the trials be comprehensive.
“This is a new disease where at the moment we do not have any proven treatments,” he said.
“The UK is absolutely determined, however, to find effective treatments for this virus disease.
“Weeks ago we began to look at clinical trials. We may not have publicised it at that point but a lot of work has been going on for weeks behind the scenes.
“Clinical trials are a gold standard way to discover whether a treatment works or not,” he said.
“But saying it works or not is rather too simplistic; the treatment has to be effective, it also has to be safe and we also have to understand the right dosage to use, the right patients to give the treatment to, and the right time in the illness to give that treatment.
“This is complicated stuff and the only way to unpick the signal and make sure we get it right is through clinical trials.”
Prof Van-Tam admitted that he was unsure when the first results and data from the trials would be available.
“My straight answer is – I don’t know, I think it’s going to be a few months. It will all depend on how quickly patients are recruited into the trials across the NHS.”
He added that he had been “astonished” and pleased by the number of volunteers that had already signed up, but stressed that the process must be one of “careful written informed consent”.
This is complicated stuff and the only way to unpick the signal and make sure we get it right is through clinical trialsProfessor Jonathan Van-Tam
One of the trials, which is called recovery and deals in hospital care, has already had more than 900 volunteers sign up.
“This is about patients who are undergoing treatment at some stage for Covid-19,” said Prof Van-Tam.
“First of all, we need the physicians in charge of their care to sign up for the clinical trial. Then it is up to the physician to approach the patient and ask them if they would like to take part.
“It is a process of very careful written informed consent for that to happen. The straight answer is yes, we do need people to take part in the clinical trials and they are doing.”