Study Detail

CLARITY

ImpaCt of bioLogic therApy on saRs-cov-2 Infection and immuniTY (CLARITY)

Status: Closed

Type: Observational

Funder: F. Hoffmann-La Roche Ltd; Hull University Teadhing Hospitals NHS Trust

Sponsor: Royal Devon and Exeter NHS Foundation Trust

CI: Dr Tariq Ahmad

IRAS-Number: 283251

CPMS-ID: 46188

Approval Date: not available

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. Using 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.This 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

Description:

The impact of immunosuppressive and immunomodulatory treatment on SARS-CoV-2 infection and disease severity is unknown, but is a major concern for patients and clinicians. Inflammatory bowel disease (IBD) affects about 1% of the UK population and is usually treated with immunosuppressive drugs. This study aims to define the impact of immunosuppressive drug therapy and physical distancing strategies on SARS-CoV-2 seroprevalence within this patient group. 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.

Study URL:

https://crohnsandcolitis.org.uk/research/research-involvement-opportunities/take-part-in-research/take-part-in-coronavirus-research-studies/clarity-trial

Back to listing