Defining IMID susceptibility to COVID-19 severe manifestations [COVID-19]
Research type
Research Study
Full title
An investigation of the severity of manifestations of COVID-19 in patients with immune-mediated inflammatory diseases
IRAS ID
285218
Contact name
Richard B Warren
Contact email
Sponsor organisation
University of Manchester
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Coronavirus disease 2019 (COVID-19) can cause a life-threatening respiratory disease driven by hyper-inflammation (over-activity of the immune system) characterised by acute respiratory distress syndrome (ARDS). Studies suggest that up to 80% of affected patients are either asymptomatic or have mild disease, 15% have severe illness requiring oxygen, and 5% develop ARDS. Some demographic factors that contribute to poor outcomes include advanced age, male sex, obesity, hypertension, and black and Asian ethnicity. It is unclear underlying immune-mediated inflammatory diseases (IMIDs) and/or treatment of IMIDS with immunomodulatory therapies can influence clinical outcomes.
IMIDs form a broad group of conditions including psoriasis, rheumatoid arthritis, and inflammatory bowel disease amongst others that have abnormalities of important immune pathways that may also be involved in the immune response to viruses.
This study aims to understand:
1. Whether people with IMIDs have altered susceptibility to the severe manifestations of COVID-19.
2. If immunomodulatory therapy alters risk of susceptibility to the severe manifestations of COVID-19 infection.Answering the first aim will require the availability of a reliable antibody test to detect asymptomatic patients. Therefore, we will contribute to the validation of an antibody test in patients taking immunomodulatory therapies. Participants will attend once for a blood test. If the test is validated in this group, we will design a study utilising the test to compare outcomes in IMID patients and a control group of participants with a positive result. To answer the second aim, we will use data from existing clinical records and databases to record outcomes of confirmed COVID-19 in patients with IMIDs, and compare the prevalence of severe outcomes in those taking an immunomodulator with those not taking an immunomodulator.
This study will involve participants or data from NHS trusts across Greater Manchester. This study is funded by the Psoriasis Association. Affinity Biomarker Labs will process one of the laboratory tests. [Study relying on COPI notice]
REC name
London - Surrey Borders Research Ethics Committee
REC reference
20/HRA/4307
Date of REC Opinion
25 Sep 2020
REC opinion
Favourable Opinion