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]
Lay Summary of Results
This study investigated the antibody response to COVID-19 vaccines in patients receiving immunosuppressant medications for immune diseases, such as psoriasis, rheumatoid arthritis and inflammatory bowel disease.
We recruited 193 participants after their first vaccine dose, and 312 participants after their second vaccine dose. We measured the antibody levels in blood samples.
After the first vaccine dose, there was a reduced chance of having a detectable antibody response (also known as seroconversion) in patients receiving methotrexate, prednisolone or rituximab compared to those receiving treatments targeting tumour necrosis factor (TNF), such as adalimumab. After the second vaccine dose, everyone seroconverted except for some patients receiving rituximab. There was a reduced chance of seroconversion with increasing age. Sex and ethnicity did not appear to influence seroconversion.
This research supported the findings of other published studies. However, it was unclear whether antibody levels truly reflected effectiveness of the vaccine, in terms of reducing the frequency or severity of COVID-19 infections.
Has the registry been updated to include summary results?: No
If yes - please enter the URL to summary results:
If no – why not?: This study is not on a registry.
Did you follow your dissemination plan submitted in the IRAS application form (Q A51)?: Yes
If yes, describe or provide URLs to disseminated materials: The research articles describing these results are freely available at these links:
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If pending, date when dissemination is expected:
If no, explain why you didn't follow it:
Have participants been informed of the results of the study?: No
If yes, describe and/or provide URLs to materials shared and how they were shared:
If pending, date when feedback is expected:
If no, explain why they haven't: As per the IRAS documentation, participants will be notified of results of the study if requested. To date, we have had no requests. If these are requested, we will generate a summary sheet of the results, and include links to the published articles which are open access.
Have you enabled sharing of study data with others?: Yes
If yes, describe or provide URLs to how it has been shared: Anonymised data will be shared on email request to ali.al-janabi@manchester.ac.uk or richard.warren@manchester.ac.uk
If no, explain why sharing hasn't been enabled:
Have you enabled sharing of tissue samples and associated data with others?: No
If yes, describe or provide a URL:
If no, explain why: Only serum was collected, and serum is not considered a tissue. Furthermore, as per the IRAS serum samples were discarded on study completion.REC name
London - Surrey Borders Research Ethics Committee
REC reference
20/HRA/4307
Date of REC Opinion
25 Sep 2020
REC opinion
Favourable Opinion