COBALT [COVID-19]
Research type
Research Study
Full title
COvid-19 vaccination and Biomarkers in cirrhosis And post-Liver Transplantation (COBALT)
IRAS ID
296513
Contact name
Rajiv Jalan
Contact email
Sponsor organisation
European Foundation for the Study of Chronic Liver Failure (EF-CLIF)
Duration of Study in the UK
1 years, 8 months, days
Research summary
The aim of this research is to study the effect of vaccination against Covid-19. Patients with liver disease have been shown to have worse outcomes from Covid-19. Additionally, we are unsure if patients with liver disease, or those with a liver transplant, have the same responses to vaccination as other ‘healthy’ individuals because these patients were not included in most clinical trials of the vaccines. Therefore, the overall aim is to see if liver disease and liver transplant patients respond as well to vaccination as healthy individuals, in terms of antibody responses as well as clinical outcomes in the 12 months following vaccination.
Eligible patients are those with cirrhosis, autoimmune liver disease, a previous liver transplant for cirrhosis, and also healthy 'control' participants. The study will be conducted at approximately 8 hospital sites in England, and a further 30-50 across Europe. The study will involve blood samples being taken from participants on a maximum of three occasions over 32 weeks, around their Covid-19 vaccination appointments. These samples will be analysed for levels of anti-coronavirus (SARS-CoV-2) antibodies, which is a marker of 'successful' vaccination. These levels in liver disease or post-transplant patients will be compared with those in healthy participants. Additionally, participants will be asked to complete a symptom diary for the 14 days following their Covid-19 vaccinations, to see if there is a difference in side-effects from vaccination in liver disease or post-transplant compared to healthy participants.
The study in total will continue for 20 months. We aim to complete recruitment of participants within 6 months, but also continue data collection for hospitalisations up to 12 months following Covid-19 vaccination. We will require a further 2 months to collect this data for the 12 month period.
REC name
South Central - Oxford C Research Ethics Committee
REC reference
21/SC/0114
Date of REC Opinion
29 Mar 2021
REC opinion
Favourable Opinion