C19 in care homes
Research type
Research Study
Full title
The association between Covid-19 immune response amongst older Residential and Nursing Care Homes residents and all-cause mortality and hospital admissions – a prospective cohort study
IRAS ID
284248
Contact name
Martyn Patel
Contact email
Sponsor organisation
Norfolk & Norwich University Hospitals NHS Foundation Trust
Duration of Study in the UK
1 years, 6 months, 30 days
Research summary
Severe acute respiratory syndrome coronavirus 2 (SARS-Cov-2) is a recently emerged virus that can cause Coronavirus disease 2019 (COVID-19), with severe acute respiratory syndrome and even death in some people, particularly the elderly and those living with medical conditions. Research is underway worldwide to better understand the virus, its aetiology and incidence of infection, the impact on healthcare systems and on individuals most at risk for the most severe form of the illness.
This study aims to fill a gap in knowledge regarding the relationship between serological antibody (immune) response to Coronavirus and severe adverse events such as hospital admission or death in individuals living in care homes in Norfolk. Crucial to the study of this type is the use of a reliable antibody test which is available in our laboratories which has specificity and sensitivity to detect Covid-19 antibodies in a community research setting.
The antibody test we have chosen to use is an enzyme-linked immunosubstrate assay (ELISA) which was developed and validated in the laboratory of Professor Krammer (Icahn School of Medicine at Mount Sinai, New York City) and has been approved by the Federal Drugs Administration. Professor Krammer provided the assay as a generous gift to the research scientists in the Bob Champion Research and Education Centre (BCRE) at the University of East Anglia (Norwich, UK).
Blood samples will be collected from care home residents (n=300) who have given informed consent, or an agreement has been provided by a consultee. At the same time, a brief questionnaire will be used to collate information on existing medical conditions and symptoms known or suspected to be Covid-19 infection. The blood samples will be transported to the UEA laboratories and the level of antibodies to the Covid-19 spike protein will be measured using an ELISA. Information will be collected by accessing death records and patient records held within Norfolk hospitals to determine whether the individuals experienced serious adverse events in the one-year follow-up period following the blood test. The outcomes will provide a snapshot of Covid-19 exposure in Norfolk care homes, a snapshot of immunity and will determine the feasibility of whether information about the presence of Covid-19 antibodies can be used prognostically.
REC name
East of England - Essex Research Ethics Committee
REC reference
20/EE/0169
Date of REC Opinion
15 Jul 2020
REC opinion
Further Information Favourable Opinion