Immune Cells in Inflammatory Arthritis With Coronaviruses, Including COVID-19

Study Overview
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Brief Summary
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A team at the University of Manchester are developing a test that tcould be helpful in detecting immunity to the Coronavirus (which causes the COVID-19 disease) in participants with inflammatory arthritis. It is based on a flu assay has already developed; the team will replace the flu antigen with a Coronavirus antigen to see if it is effective. This project aims to develop a test to see if people who have had the virus have developed immunity to it. This could help to predict who might or might not get the disease a second time, who should stay at home to be protected from potential infection or who will not develop any symptoms, even if exposed to the virus. When vaccination trials against the Coronavirus will be launched, this test could also help to see if the vaccine is effective.

Official Title
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Immune Cells and the Coronavirus for Inflammatory Arthritis

Conditions
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SARS Virus

Intervention / Treatment
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* Other: 40ml blood sample


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Has previously taken part in either the BRAGGSS or National Repository Healthy Volunteer Study Has agreed to be contacted abut future research projects Has previously provided a blood sample for either the BRAGGSS or National Repository Healthy Volunteer Study Is willing to complete the informed consent form, registration slip, questionnaire and provide a 40ml blood sample Has a good written understanding of English Exclusion Criteria: Has not previously taken part in either the BRAGGSS or National Repository Healthy Volunteer Study Has not agreed to be contacted abut future research projects Has not previously provided a blood sample for either the BRAGGSS or National Repository Healthy Volunteer Study Is not willing to complete the informed consent form, registration slip, questionnaire and provide a 40ml blood sample Has not got a good written understanding of English

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy Volunteers<br>These people will have already provided at least one sample as part of the National Repository Healthy Volunteer Study. We aim to take blood samples from participants who have recovered from COVID-19 and compare them with blood samples we already have which were taken before the COVID-19 pandemic. We will need to compare these samples to other samples, so we will also need to blood samples from people who have not had COVID-19 (who have either tested negative or never had any symptoms). | Other: 40ml blood sample<br>* We'll be collecting cells, DNA and serum.<br>|
| Rheumatoid Arthritis<br>These people will have already provided at least one sample as part of the BRAGGSS Study. We aim to take blood samples from participants who have recovered from COVID-19 and compare them with blood samples we already have which were taken before the COVID-19 pandemic. We will need to compare these samples to other samples, so we will also need to blood samples from people who have not had COVID-19 (who have either tested negative or never had any symptoms). | Other: 40ml blood sample<br>* We'll be collecting cells, DNA and serum.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence and abundance of CD4+ T lymphocytes | the prevalence and abundance of CD4+ T lymphocytes specifically recognizing SARS-CoV-2 in COVID-19 patients with inflammatory arthritis, in pre- and post-infection samples; in patients without COVID-19 and in healthy volunteers with or without COVID-19. Correlation of these cells with COVID-19 severity. | 2 years |