PROphylactic TrEatment of COVID in Care Homes Trial (PROTECT)

The COVID-19 pandemic has had a devastating impact on care homes, causing illness and death and leading to restrictions on daily routines, including restricted visiting, that have impacted adversely on the health and wellbeing of residents and their relatives. Beyond public health measures to prevent infection (hygiene, masks, personal protective equipment, maintaining distance), we urgently need interventions to reduce the spread and severity of infection. Treatments, such as dexamethasone, may improve outcomes for care home residents who are sufficiently unwell. Vaccination against SARS-CoV-2 has commenced in care homes but its efficacy in older people with multiple comorbidities and immunosenescence is not yet established. It is likely that, even after vaccination, sporadic outbreaks of COVID-19 will continue to occur in care homes. We need to establish whether preventative treatments work in this setting to reduce either the transmission or severity of COVID-19. Such approaches should be complementary to vaccination and acute treatments. We will set up a large platform cluster-randomised trial that will test several treatments intended to reduce the spread of COVID-19 within care homes and/or reduce the risks of hospitalisation and death. We will study between one and three treatments at a time, which will be identified by the NIHR Prophylaxis Oversight Group. Treatments will be replaced in the study as they are shown to be either effective or ineffective. This process can, in principle, go on for many months or years. Care homes will be randomised to either active treatment or control. We will recruit approximately 12,000 residents from 400 care homes for older people (some of whom will include some younger people) from across the UK to allow three treatments to be compared with control/standard of care. We expect most of the interventions will be given for two months before their efficacy is tested. The ordinal primary outcome will be: all cause death, hospitalisation (or intent to hospitalise) for SARS-CoV-2 infection, asymptomatic or symptomatic infection in residents remaining in the care home, and no infection. Secondary outcomes will include the components of the primary outcome, referral for healthcare support, time to infection, cause-specific mortality, serious adverse reactions relevant to the intervention(s), cost effectiveness and process evaluation. We will also contribute to the development of a core outcome set for COVID-19 in social care settings. We will develop training materials including video and audio descriptions for care home staff and information sheets for residents to allow them to make an informed decision on whether to participate. These will be adapted for use by family members who will make decisions on behalf of residents who do not have mental capacity to provide consent. Patient Public and Carer involvement, including with Black and Minority Ethnic representation, will be embedded in the study through a hub (based with the trial team) and spoke (regional centres) model and will review all study materials and outputs. The trial will be run from the University of Nottingham with collaborators at the Universities of Cambridge, Edinburgh, Surrey and Warwick, and University College London. Our team of doctors, statisticians, trial methodologists, health economists, qualitative scientists and public partners are experienced in care home research. We will make the results of the trial rapidly available to ensure that COVID-19 guidelines are quickly updated and to prevent impact delay. This will include creating summaries for the general public, care home residents and their loved ones.