A UK-wide clinical trial, PROTECT, funded by The National Institute for Health Research (NIHR) and conducted by The University of Nottingham, launches today which aims to identify treatments that can protect care home residents from developing COVID-19.
Residents in care homes have suffered greatly during the COVID-19 pandemic. According to researchers, many potential treatments have been proposed that might prevent COVID-19 but none have been tested in care homes. Prophylactic Therapy in Care homes (PROTECT) is a platform trial that will test one or more treatments with the aim of reducing the risk of care home residents catching the virus that causes COVID-19 and of developing severe disease.
Study researchers have said that beyond public health measures to prevent infection (hygiene, masks, personal protective equipment, maintaining distance), we urgently need treatments to minimise the impact on residents.
The Nottingham Clinical Trials unit will set up a large clinical trial platform that will test several treatments intended to reduce the spread of COVID-19 within care homes and reduce the risks of hospitalisation and death. A trial platform allows multiple treatments to be tested in parallel, with results analysed regularly. As soon as a treatment is shown to be effective or ineffective, it is removed from the platform. Researchers say this makes space for new treatments to be added and rapidly evaluated. This process of testing treatments and then replacing them with new ones can go on for many months or years. It’s said that the treatments to be tested will be chosen by Government advisors.
The trial will recruit more than 400 care homes from across the UK and approximately 12,000 residents. Care homes will be randomised to treatment or standard care (no additional treatment). Researchers expect most of the treatments to be given for two months before they can see whether they have worked, and whether the treatments are cost-effective. They will then develop training materials including videos and audio descriptions for care home staff. For residents, (or relatives who will make decisions on their behalf if they do not have capacity) study researchers will provide information on the study and the treatments to help them make an informed decision on whether to take part.
The University of Nottingham said resident, relative and carer involvement is central to the study and they will seek to be representative of the communities the care homes serve based on gender and ethnicity.
The study will be run from the University of Nottingham with involvement by the Universities of Cambridge, Edinburgh, Surrey and Warwick, and University College London.
The research team has assisted with the running of other COVID-19 platform trials including RECOVERY, AGILE and PRINCIPLE. Researchers will make the results of the PROTECT platform rapidly available to ensure that COVID-19 guidelines are quickly updated and actioned. This will include creating summaries for the public, GPs, care home staff, residents and their loved ones.
People living in residential and nursing homes across the UK can take part, but first, their care home must be part of the study. If you are a care home manager and want to take part, please complete this survey.
Visit the PROTECT Trial website for more information.
On 14th January, CMM hosted a free Zoom webinar on behalf of the National Care Forum, calling on all providers to share their experiences of COVID-19. Find out more.