PROTECT-CH
Research type
Research Study
Full title
COVID-19: Prophylactic therapy in care homes trial-CH
IRAS ID
294832
Contact name
Philip Bath
Contact email
Sponsor organisation
University of Nottingham
Eudract number
2021-000185-15
Duration of Study in the UK
1 years, 7 months, 27 days
Research summary
The COVID-19 pandemic has had a devastating effect in care homes causing illness and death in residents and staff. Measures to reduce viral spread into care homes (e.g. limiting family visits) have had a significant impact on the health and wellbeing of residents. Additional action beyond public health measures to prevent infection (hygiene, masks, personal protective equipment, maintaining distance) is urgently needed to minimise the impact of COVID-19 on residents.
The PROTECT-CH trial is a large “platform” trial 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 at the same time 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 tested. The treatments to be tested will be chosen by Government scientific advisors and may be for pre-exposure prophylaxis (PrEP, i.e. before the care home has a case) and/or post-exposure prophylaxis (PEP, once the care home has a new case to control an outbreak).
Each comparison of a treatment with standard care will require 200 care homes i.e. in the region of a total of 6,400 residents. Care homes will be randomised (like a toss of a coin) to treatment or usual care (no additional treatment). It is expected that most of the treatments will be given for up to two months before it is known whether they have worked, and whether the treatments are cost-effective.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
21/SC/0166
Date of REC Opinion
18 May 2021
REC opinion
Favourable Opinion