PRISM [COVID-19]
Research type
Research Study
Full title
Pneumonia Risk and Immunity Study in Mental Illness
IRAS ID
282869
Contact name
Oliver Howes
Contact email
Sponsor organisation
King's College London
Clinicaltrials.gov Identifier
n/a, n/a
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
People with severe mental illness are at increased risk of developing pneumonia, and increased risk of poorer outcomes such as death and intensive care admission when they do develop it. Patients on antipsychotics, particularly clozapine, are at a further elevated risk. They are therefore very likely to be at increased from the current COVID-19 pandemic. \nSecondary bacterial infections are a major cause of morbidity and mortality from influenza, and vaccination against pneumococcus (the leading cause of community acquired pneumonia in the UK) improves outcomes during influenza pandemics. This may be by preventing secondary bacterial infections, or by changing the function of the immune system. \nPreliminary evidence suggest that up to 50% of people who die from COVID-19 have secondary bacterial infections. In response, South London and Maudsley (SLaM) NHS Foundation trust has introduced a policy to offer pneumococcal vaccination to patients at increased risk of pneumonia as part of routine clinical care. The vaccine is being offered to clozapine-treated patients during already scheduled essential clinical visits.\n\nWhilst it has been shown that pneumococcal immunisation improves outcomes during influenza outbreaks, it is not clear if this is the case with SARS-CoV-2 infection, or if there are differences between patients who accept immunisation and those who decline it. In view of this, we aim to conduct an observational cohort study of patients who have received and those who have not received the pneumococcal vaccine to evaluate if there are differences in clinical outcomes (mortality, hospitalisation, risk of SARS-CoV-2 infection, intensive care admission, ventilation) and if there are clinical or demographic factors that influence choice to accept the vaccine. As an exploratory outcome, we also aim to study the effect of the pneumococcal vaccine in modulating the immune system to clarify the mechanism by which it may provide protection from pneumococcus and COVID-19.\t\n\n
REC name
London - Surrey Research Ethics Committee
REC reference
20/HRA/1987
Date of REC Opinion
23 Jul 2020
REC opinion
Further Information Favourable Opinion