Two new clinical trials to develop treatments to prevent people catching COVID-19 are to launch in the UK.
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Hundreds of thousands of the UK’s most vulnerable people could be set to benefit from innovative treatments that stop them catching COVID-19, as 2 new government-funded clinical trials launch in the UK.
The trials will test the effectiveness of treatments - which have already shown promising early results for treating COVID-19, in preventing the virus and therefore its transmission among care home residents and those with weakened immune systems, such as transplant patients or those on dialysis.
Any treatment proven to be safe and effective will be rapidly made more widely available on the NHS, and will mean people for whom COVID-19 vaccines may be less effective due to their lowered immune systems - such as cancer patients - will have additional protection to prevent infection and serious illness.
Matt Hancock, Health and Social Care Secretary, said: "Since the beginning of the pandemic, we have worked to find the best treatments the world has to offer for COVID-19. It’s down to this dedication and the renowned expertise of British scientists, supported by taxpayers, that the UK was able to identify and rollout 2 lifesaving treatments for COVID-19 to NHS patients – dexamethasone and tocilizumab.
"The government is backing 2 more innovative UK-based clinical trials into effective therapeutics, this time specifically for the most vulnerable groups who need them most.
"We have been clear from the outset that it will be a combination of safe and effective vaccines, testing and therapeutics that will bring an end to this pandemic, and we will not rest until every individual in the country is protected against this awful disease."
Professor Chris Whitty, Chief Medical Officer for England and co-lead for the National Institute for Health Research (NIHR), said: "These 2 important NIHR-funded studies will evaluate prophylactic treatments for COVID-19 in care homes and for those with compromised immune systems. The more proven clinical tools we can use to protect these very vulnerable groups the better, so I encourage as many eligible individuals, care home operators and residents to take part in these studies."
The PROTECT-V trial, run by the University of Cambridge, will look at potential COVID-19 treatments’ effectiveness in reducing the spread of the virus amongst immunocompromised groups. It launched this month and will last at least 12 months.
There are at least 500,000 people who could benefit from these treatments in England alone, and 2,250 are expected to take part in the clinical trial.
The PROTECT-CH trial, run by the University of Nottingham, will also look at treatments for reducing transmission and serious illness from the virus, for care homes, their residents and staff. The trial will begin in May 2021 and last around 2 years.
It aims to recruit more than 400 care homes to take part, covering approximately 12,000 elderly residents, with any approved treatments having the potential to be rolled out to the 420,000 care home residents across the UK.
Lord Bethell, Minister for Innovation, said: "The UK has shown time and time again its tenacity in identifying safe and effective treatments for COVID-19, and we are working tirelessly to support these innovations so they can help protect people in all corners of the UK.
"Vulnerable groups have been disproportionately impacted by the virus and these government-funded trials will provide us with invaluable data so we can ensure they get every possible form of defence against the virus. I urge as many care homes and eligible people to sign up for these trials as possible, and to play a part in securing future treatments for the most at-risk in our society."
The clinical trials have now received Urgent Public Health badging status from the National Institute for Health Research (NIHR). PROTECT-CH has been awarded £1.7 million of government funding. PROTECT-V has been awarded an additional up to £1.5 million to expand its trial platform.
Throughout the pandemic, the government has supported British research with millions of pounds of funding for clinical trials into the most promising and innovative medicines in our fight against the virus, including for the RECOVERY and REMAP-CAP trials that have brought lifesaving treatments dexamethasone and tocilizumab to NHS patients.
Dr Rona Smith, Senior Research Associate for PROTECT-V at the University of Cambridge, said: "The PROTECT-V trial is a platform designed to test drugs that may prevent COVID-19 infection in vulnerable patients with kidney disease, either on dialysis, who have a kidney transplant or are receiving immunosuppression.
"COVID-19 has had a huge impact on the lives of these patients. The rapid roll out of vaccination has been very welcome news, but it is unclear if these patients will mount as strong responses to the vaccine as healthy individuals. This trial will test if drugs may offer additional protection over and above the vaccine in vulnerable individuals and prevent them becoming unwell with COVID-19 infection."
Professor Philip Bath, lead researcher for PROTECT-CH at the University of Nottingham, said: "Care homes have seen high rates of illness and death due to COVID-19 throughout the pandemic. Apart from vaccines, there are no drugs for preventing serious COVID-19 and the PROTECT-CH trial is designed to test drugs that might reduce infection, hospital admission and death." ■
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