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

Immune Cells and the Coronavirus for Inflammatory Arthritis

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.

Study Overview

• Status: Unknown
• Conditions: SARS Virus
• Intervention / Treatment: Other: 40ml blood sample

• Study Type: Observational
• Enrollment (Anticipated): 125

Contacts and Locations

Study Locations

• United Kingdom
  • Greater Manchester
    • Manchester, Greater Manchester, United Kingdom, M13 9WL
      • Universit of Manchester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

People who have previously taken part in (and provided at least 1 set of blood samples to) either the BRAGGSS or National Repository Healthy Volunteer Studies and have given us permission to contact them for future research

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy Volunteers; 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; We'll be collecting cells, DNA and serum.
Rheumatoid Arthritis; 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; We'll be collecting cells, DNA and serum.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Manchester

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Anticipated): May 1, 2021
• Study Completion (Anticipated): May 1, 2021

Study Registration Dates

• First Submitted: April 20, 2020
• First Submitted That Met QC Criteria: April 23, 2020
• First Posted (Actual): April 27, 2020

Study Record Updates

• Last Update Posted (Actual): November 5, 2020
• Last Update Submitted That Met QC Criteria: November 3, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Arthritis
• Other Study ID Numbers: 282566

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No