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

Sponsor
University of Manchester (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04363047
Collaborator
(none)
125
1
7
17.9

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: 40ml blood sample

Study Design

Study Type:
Observational
Anticipated Enrollment :
125 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Immune Cells and the Coronavirus for Inflammatory Arthritis
Actual Study Start Date :
Oct 1, 2020
Anticipated Primary Completion Date :
May 1, 2021
Anticipated Study Completion Date :
May 1, 2021

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Prevalence and abundance of CD4+ T lymphocytes [2 years]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Universit of Manchester Manchester Greater Manchester United Kingdom M13 9WL

Sponsors and Collaborators

  • University of Manchester

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr. Sebastien Viatte, Lecturer in Genetics, University of Manchester
ClinicalTrials.gov Identifier:
NCT04363047
Other Study ID Numbers:
  • 282566
First Posted:
Apr 27, 2020
Last Update Posted:
Nov 5, 2020
Last Verified:
Nov 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 5, 2020