Two new government-funded clinical trials have been launched in the UK, with the aim of preventing vulnerable people from catching COVID-19.
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.
Professor Chris Whitty, Chief Medical Officer for England and co-lead for the National Institute for Health Research (NIHR), said: “These two 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, but for care homes, their residents and staff. The trial will begin in May 2021 and last around two 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.
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 rollout 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."
