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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04363047
Other study ID # 282566
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date October 1, 2020
Est. completion date July 31, 2026

Study information

Verified date May 2024
Source University of Manchester
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 125
Est. completion date July 31, 2026
Est. primary completion date July 31, 2026
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
40ml blood sample
We'll be collecting cells, DNA and serum.

Locations

Country Name City State
United Kingdom University of Manchester Manchester Greater Manchester

Sponsors (1)

Lead Sponsor Collaborator
University of Manchester

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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