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General Residents and Legal Representatives

Since the start of the pandemic, the lives of care home residents and their relatives have been greatly affected by COVID-19. Efforts to reduce spread of the coronavirus into care homes, such as limiting family visits, have had a significant impact on the health and wellbeing of residents. Therefore, we need to find medications to minimise this impact. Government health ministers have asked us to set up this trial to find out how we can protect care home residents from COVID-19. We will try out different medications to see which ones may help, so that residents can stay well and resume a more normal life.

General Residents and Legal Representatives

The aim of the trial is to see if we can find medications to prevent or reduce the spread and impact of COVID-19 in care homes.

General

Care homes have made major changes and advances in reducing the risk of COVID-19 through introducing personal hygiene measures (“hands, face, space”) and personal protective equipment (PPE; masks, visors, gloves, aprons/gowns). The success in vaccinating residents will further reduce the risk of COVID-19 in care homes. However, the COVID-19 vaccine may not completely stop infection for several reasons:

  1. No vaccine is 100% effective, so some vaccinated people will still get infected and will go on to develop severe disease. The clinical trials of COVID-19 vaccines have shown that between 60% and 95% of participants were protected. It is important to note that none of the vaccine trials tested people in their 80s/90s/100s. The average age of care home residents is around 85 years, so it is possible the vaccines may be less effective in this group, especially since immune function declines with advanced age.
  2. Although vaccines are likely to reduce transmission, some virus can still be passed on between staff/residents/family to other residents.
  3. If the virus mutates, these changes may further reduce the benefit of existing vaccines. Already, some new variants of the virus appear to be partially resistant to existing vaccines and it is likely that future variants could make this problem worse. Vaccine manufacturers are already preparing to modify their vaccines to make them effective in the future although the next generation of vaccines may be many months away. This is similar to seasonal ‘flu, where a new version of the vaccine is developed each year to deal with recent changes to the ‘flu virus.

  4. Initially we will look at different ways of using existing medications to prevent and treat COVID-19 when present measures (such as hygiene, PPE and vaccines) aren’t enough. The main purpose of the PROTECT-CH trial is to find additional ways to reduce COVID-19 infection and its devastating impact on care home residents.

  5. If the PROTECT-CH trial finds that medications can prevent or reduce COVID-19 infection in care homes, then they may also work to protect the wider community.

General

Residents in UK residential or nursing care homes may join the trial, but first, their care home must sign up to be part of the trial.

General Residents and Legal Representatives

More information about the trial medications is available in the Participant Information Sheet or Legal Representative Information Sheet.

General

Care homes will be allocated to either usual care alone (no additional trial medication) or to usual care plus a trial medication. Allocation to usual care or usual care plus a trial medication will be decided at random, i.e. like a toss of a coin. This is to ensure a fair comparison of the trial medications. Residents from the same care home who enrol in the trial will all receive the same trial medication.

General

Care homes across all the four nations within the United Kingdom will be involved (England, Northern Ireland, Scotland and Wales).

General

The trial is currently being set up and we welcome expression of interests from care homes. We do not know yet when residents will begin receiving the first trial medications.

General

There is no end date at present, but we will make the results of the trial rapidly available to ensure that medications can be introduced without delay and COVID-19 clinical guidelines are quickly updated.

General Residents and Legal Representatives

The trial is being organised by the University of Nottingham (the Sponsor) and coordinated by the Nottingham Clinical Trials Unit (NCTU). It is being led by Professor Phillip Bath. The trial is funded through the National Institute for Health Research (NIHR) Health Technology Programme (NIHR 133443).

All research in the NHS is looked at by an independent group of people, called a Research Ethics Committee, to protect your interests. This trial has been reviewed and given favourable opinion by South Central – Oxford A Research Ethics Committee. 

Lay members of the public are involved in the teams that oversee the running of the trial and have helped develop the materials for residents and legal representatives. 

General

Patients’ representatives were involved in designing the trial and in applying for the funding to carry out the trial. Lay members of the public are involved in the teams that oversee the running of the trial and they have helped develop the materials for residents and legal representatives.