Covid-19 Long Immunité IMagerie (CLIIM) (NCT06528171) | Clinical Trial Compass
RecruitingNot Applicable
Covid-19 Long Immunité IMagerie (CLIIM)
France200 participantsStarted 2024-12-06
Plain-language summary
Covid-long pathology affects a large number of patients, and represents a major medical, economic and societal challenge. To date, we have no objective criterion for a definitive diagnosis, nor any predictive tool for monitoring the evolution of Covid-long. Based on recruitment from the infectious diseases department of Nice University Hospital, the investigator's team wants to conduct an innovative pathophysiological study to better define the disease and identify specific biomarkers that could subsequently be used as a diagnostic tool for Covid-long. 120 participants will be initially included for the model learning phase: 60 controls in the CL- cohort and 60 patients in the CL+ cohort. Then 80 patients (40 CL+ and 40 Cl-) will be enrolled for the model validation phase.
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.
FOR CL+ PATIENTS
Inclusion Criteria:
* Case definition in line with WHO Delphi process
Exclusion Criteria:
* History of chronic fatigue syndrome diagnosed before or after Covid.
* History of progressive psychiatric pathology.
* History of acute Covid requiring admission to intensive care and mechanical ventilation.
* No social security affiliation.
FOR CONTROL (CL-)
Inclusion Criteria:
* History of acute COVID-19, mild, moderate or severe (episode at least 3 months at the time of inclusion).
* Absence of persistent symptoms more than 3 months after first Covid symptoms (or mild not affecting daily activities).
Exclusion Criteria:
* History of progressive psychiatric pathology.
* History of acute Covid requiring admission to intensive care and mechanical ventilation.
* No social security affiliation.
* Pregnant or breast-feeding.
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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.