SARS VirusNCT04363047
Immune Cells in Inflammatory Arthritis With Coronaviruses, Including COVID-19
An observational study of SARS Virus, run by University of Manchester at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SARS Virus
- What is being tested?
- 40ml blood sample
- How many people
- 125 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Oct 2020to 31 Jul 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Manchester
Manchester, Greater Manchester, M13 9WL
About this study
Official title: 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.
- Conditions
- SARS Virus
- Being tested
- 40ml blood sample
- Medical subject headings
- Severe Acute Respiratory Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
40ml blood sampleOther
We'll be collecting cells, DNA and serum.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Other: 40ml blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2020
- Study start1 Oct 2020
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS VirusStudies of the same condition, open and under way.
- More trials run by University of ManchesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Sebastien Viatte, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04363047
- Sponsor's protocol ID
- 282566
- Status last verified
- May 2024
- First submitted
- 20 Apr 2020
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Cells and the Coronavirus for Inflammatory Arthritis
- ClinicalTrials.gov ID
- NCT04363047
- Acronym / sponsor ID
- 282566
- Conditions
- SARS Virus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 27 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | – | Other: 40ml blood sampleThese 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). |
| Rheumatoid Arthritis | – | Other: 40ml blood sampleThese 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 40ml blood sampleWe'll be collecting cells, DNA and serum. | Other | Healthy Volunteers, Rheumatoid Arthritis |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS Virus, run by University of Manchester at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence and abundance of CD4+ T lymphocytes (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.