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Clarity IBD

Safe People

Organisation name

Royal Devon and Exeter NHS Foundation Trust

Organisation sector

CQC Registered Health or/and Social Care provider

Applicant name(s)

Tariq Ahmad

Safe Projects

Project ID

eDRIS-2021-0234

Lay summary

The CLARITY trial is looking at the impact of two biologic medicines (infliximab and vedolizumab) on COVID-19 infection, vaccination and immune response in people with Crohn’s or Colitis. The study also takes into account other medicines that people may be taking alongside their infliximab or vedolizumab, for example azathioprine or methotrexate. The researchers want to see if people on these medicines produce the same immune response to coronavirus and to coronavirus vaccines. CLARITY is a one year study led by the IBD research team at the Royal Devon and Exeter NHS Foundation Trust and the University of Exeter Medical School. The study involves 6,935 patients from 92 UK hospitals. Crohn’s & Colitis UK are supporting this research. Researchers are using blood samples collected since the start of 2020 to look at differences in positive antibody rates between people with Crohn’s or Colitis on different drugs, and then look at what happens people have the first and second doses of their coronavirus vaccines.

Latest approval date

11/02/2021

Safe Data

Dataset(s) name

COVID19 test

SICSAG (Scottish Intensive Care Society Audit Group)

COVID19 Vaccination

General Acute Inpatient and Day Case - Scottish Morbidity Record (SMR01)

National Records of Scotland (NRS) - Deaths Data

Safe Setting

Access type

Release