The team are initially looking for up to 400 care homes to take part in the ground-breaking trial – called PROTECT.
As part of the trial, researchers will test drugs that already show promise for treating Covid-19, but will use them to prevent Covid-19 instead. The team will focus on care home residents because they are at high risk from Covid-19, and although priority has been given to them for vaccination, the effectiveness of vaccines in this group has not yet been fully established. The aim is to reduce the number and severity of Covid-19 cases in those homes.
The UK has more than 21,000 care homes looking after 420,000 residents, many of whom have dementia or physical care needs. Up to half of all Covid19 deaths in the UK have occurred in care homes. If PROTECT can identify an effective drug to reduce the severity of Covid-19, and the likelihood of transmission, then this, alongside other measures, could help enable a return to a more normal life for care home residents and their families, including more liberal visiting policies.
Apart from vaccines, there are no drugs for preventing serious Covid-19 and we believe that the PROTECT trial has a good chance of finding one or more drugs that might reduce the awful death rates seen in care homes.”
The trial will have a “platform” structure like the RECOVERY trial, which has rapidly evaluated candidate treatments for Covid-19. However, PROTECT will randomise care homes (rather than individual residents) to one of up to three drugs or no additional treatment, in a cluster randomised controlled design. This design allows several drugs to be tested in parallel and then for new drugs to be added once the first candidates have been shown to be beneficial or have no useful effect. Treatment will be given alongside the ongoing vaccination programme.
The trial will be coordinated from the University of Nottingham working with colleagues from the Universities of Edinburgh, Cambridge, Cardiff, Surrey and Warwick and Queen’s University Belfast and University College London.
Professor Adam Gordon, President-Elect of the British Geriatrics Society and co-chief investigator at the University of Nottingham said: “Having worked closely with care homes throughout the pandemic, I have seen how hard it has been for residents, their families and staff to deal with the high rates of illnesses and deaths, and the associated loss of routine, including visiting. The announcement of PROTECT is an important step towards finding preventative treatments that might help restore normality. The agents investigated may have important protective effects in future virus outbreaks, even after the pandemic has passed.”
Vic Rayner, Executive Director of the National Care Forum, said: “This trial is hugely important on so many levels. Firstly, it will enable detailed research with the intention of identifying lifesaving interventions that could prevent some of our most vulnerable citizens from contracting Covid-19. And secondly, because it recognises that those living within care homes continue to have a vital contribution to make towards society, and prioritises medical research which puts their health and wellbeing front and centre of scientific considerations.”
Vulnerable care homes residents have been disproportionately impacted by this virus and we are working tirelessly to find effective ways of protecting those most at risk. This is a very promising development for the UK and I actively urge as many care homes as possible to get involved with this trial, which the government is backing through the National Institute for Health Research. Together, we can play a part in helping to ensure the most vulnerable in our society are given every possible form of defence against the virus.”
Care homes interested in taking part in the trial should contact the researchers via the website at www.protect-trial.net or by email firstname.lastname@example.org