PROTECT-CH trial summary
Prophylactic Therapy in Care Homes Trial (PROTECT-CH)
The COVID-19 pandemic has had a devastating effect in care homes. COVID-19 causes illness and death in care home residents and staff. Measures to reduce viral spread into care homes such as limiting family visits, impact on health and wellbeing of residents. Beyond public health measures to prevent infection (hygiene, masks, personal protective equipment, maintaining distance), we urgently need treatments to minimise these impacts on residents.
We 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. 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. The treatments to be tested will be chosen by government advisors.
We will recruit more than 400 care homes from across the UK and approximately 12,000 residents. Care homes will be randomised (like a toss of a coin) to treatment or standard care (no additional treatment). We expect most of the treatments to be given for two months before we can see whether they have worked, and whether the treatments are cost-effective. We will 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) we will provide information on the study and the treatments to help them make an informed decision on whether to take part.
Resident, relative and carer involvement is central to the study, and we will seek to be representative of the communities the care homes serve based on gender and ethnicity. Our resident, relative and carer partners have already contributed to the development of the funding application and design of the trial, supported by members of the research team who have worked on other trials in care homes and with older adults. Our partners will continue to advise and support involvement with the care homes, including training, and understanding the results of the study. 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.
Our team of doctors, statisticians, trial methodologists, health economists and resident, relative and carer partners has considerable experience in care home research, including clinical trials. The research team has assisted with the running of other COVID-19 platform trials including RECOVERY, AGILE and PRINCIPLE. We will make the results of the PROTECT-CH 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.