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OpenTrials
Enrolling by Invitation

NCT Number: NCT04363047

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

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.

Enrolling by Invitation

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Key information

Conditions

SARS Virus Coronaviridae Infections Coronavirus Infections Infections Nidovirales Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Severe Acute Respiratory Syndrome Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Manchester

Manchester, Greater Manchester, M13 9WL, United Kingdom

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

40ml blood sample

Other

We'll be collecting cells, DNA and serum.

Primary outcomes

  1. Prevalence and abundance of CD4+ T lymphocytes

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Manchester

Other

Registry information

Official study title

Immune Cells and the Coronavirus for Inflammatory Arthritis

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Apr 27, 2020
Registry last updated
May 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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