Serologic Profile of SARS CoV2 in COVID-19 Patients With Systemic Diseases (NCT04530461) | Clinical Trial Compass
UnknownNot Applicable
Serologic Profile of SARS CoV2 in COVID-19 Patients With Systemic Diseases
Tunisia200 participantsStarted 2020-06-01
Plain-language summary
An observational study aiming to assess the serological profile of SARS-Cov2 patients with systemic diseases such as systemic lupus erythematosus, Sjogren syndrome, sarcoidosis, inflammatory myopathies, Behçet's disease, Rheumatoid arthritis and Spondyloarthritis
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age over 18 years old
* One of the following conditions: systemic lupus, Sjögren's syndrome, rheumatoid arthritis, inflammatory myopathies, spondyloarthritis, sarcoidosis and Behçet's disease.
* Informed consent obtained and signed
Exclusion Criteria:
* Refusal to repeat blood sampling if the first one was badly performed
* Informed consent not obained
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this study is specifically looking at the serological profile — meaning blood antibody and immune response patterns — of COVID-19 in people with conditions like lupus, Sjögren's syndrome, rheumatoid arthritis, or sarcoidosis, could you help me understand how participating might give us useful information about how my specific systemic disease affects my immune response to SARS-CoV-2?
2This trial is listed as 'observational' in nature given it's measuring serological profiles rather than testing a treatment — does that mean participation would mostly involve blood tests, and if so, how would that fit alongside my current care routine?
3Because this trial is Phase NA and focuses on data collection rather than a new therapy, is there any direct benefit to me personally, or is the value primarily in contributing to research that could help others with systemic diseases like mine?
4The recruitment status for this trial is listed as 'unknown' — do you know whether this study is still actively enrolling patients, and if not, are there similar ongoing studies I should consider?
5Given that my condition involves an immune system that may already be altered by disease or immunosuppressive medications, would my current treatment regimen affect the serological data I could contribute, and is that something the study investigators would need to know about?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.