CLARITY: impaCt of bioLogic therApy on saRs-cov-2 Infection & immuniTY [COVID-19] [UPH]
Research type
Research Study
Full title
IMPACT OF BIOLOGIC AND IMMUNOMODULATORY THERAPY ON SARS-COV-2 INFECTION AND IMMUNITY IN PATIENTS WITH INFLAMMATORY BOWEL DISEASE. \n
IRAS ID
283251
Contact name
Tariq Ahmad
Contact email
Sponsor organisation
Royal Devon and Exeter Hospital NHS Trust
ISRCTN Number
ISRCTN45176516
Clinicaltrials.gov Identifier
N/A, 20/HRA/3114
Duration of Study in the UK
1 years, 11 months, 31 days
Research summary
Inflammatory bowel disease (IBD) affects about 1% of the UK population and is usually treated with immunosuppressive drugs. Side effects include an increased risk of serious infection, most notably pneumonia. Vaccination studies also show these drugs impair protective antibody responses. The impact of immunosuppressive treatment on SARS-CoV-2 infection and disease severity is unknown but is a major concern for patients and clinicians. As a precaution, the UK Government advised prolonged shielding for many patients treated with these drugs. \n\nUsing the Roche Elecsys immunoassay to test serum samples from >7500 IBD patients stored since the start of the pandemic, a questionnaire aligned to the Covid Symptom Study and Public Health England data, we will report the SARS-CoV-2 emerging seroprevalence. We will simultaneously conduct a 12-month prospective study of an additional 6970 patients treated with infliximab (anti-TNF) versus vedolizumab (anti-integrin) using our established clinical network of UK IBD centres. Data from both cohorts will be used to define the impact of immunosuppressive drug therapy and physical distancing strategies on SARS-CoV-2 seroprevalence. Serial testing in the prospective cohort will define the durability and magnitude of protective immune responses.\n\nThis study will provide an evidence base for safer prescribing of immunomodulator and biologic drugs in the COVID-19 era and inform public health policy regarding physical distancing measures, and future vaccination strategies. Although this study will define risk in IBD patients, there are potentially important lessons to be learned for millions of patients across the UK with other immune mediated diseases treated with similar therapies.\n
REC name
London - Surrey Borders Research Ethics Committee
REC reference
20/HRA/3114
Date of REC Opinion
1 Jul 2020
REC opinion
Further Information Favourable Opinion