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

NCT04363047 | Enrolling By Invitation

• 1 other identifier: 282566
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 1

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.

Conditions

SARS Virus

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

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

Interventions

40ml blood sample OTHER

We'll be collecting cells, DNA and serum.

Healthy Volunteers; Rheumatoid Arthritis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Manchester: lead

Study Sites (1)

University of Manchester

Manchester, Greater Manchester, M13 9WL, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Severe Acute Respiratory Syndrome

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer in Genetics

Study Record Dates

• First Submitted: April 20, 2020
• First Posted: April 27, 2020
• Study Start: October 1, 2020
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)