COVID Long-HaulCLIIMNCT06528171
Covid-19 Long Immunité IMagerie (CLIIM)
A study testing Brain MRI and Specific blood samples in people with COVID Long-Haul, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID Long-Haul
- What is being tested?
- Brain MRI and Specific blood samples
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 6 Dec 2024to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Case definition in line with WHO Delphi process
- 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).
Who cannot join
- 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-)
- History of progressive psychiatric pathology.
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- History of acute Covid requiring admission to intensive care and mechanical ventilation.
- No social security affiliation.
- Pregnant or breast-feeding.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de NICE
Nice, 06200
TOUITOU Irit, 04 92 03 58 47, touitou.i@chu-nice.fr
Michel CARLES, PhD
About this study
Official title: Specific Markers of Covid-long Syndrome: Identifying the Mechanisms Involved With a View to Defining Diagnostic Criteria
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.
- Conditions
- COVID Long-Haul
- Being tested
- Brain MRI, Specific blood samples
- Medical subject headings
- Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain MRIProcedure or surgery
non injected brain MRI
Specific blood samplesBiological
blood samples to find immunological and inflammatory markers
| Study group | Role | What they receive |
|---|---|---|
| Covid-long (CL+) | Other | Assessment of musculoskeletal disorders, cognitive and neurocognitive assessments, Behavioral assessment, Work Difficulty Scale, Digital testing, brain MRI, Biological Analysis Receives: Procedure: Brain MRI; Biological: Specific blood samples |
| Acute Covid (CL-) | Other | Brain MRI, Biological Analysis Receives: Procedure: Brain MRI; Biological: Specific blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive model of Covid-long
Build and validate a multivariate predictive model of Covid-long considering immunological, inflammatory and brain imaging markers.
Measured: 24 months
Secondary outcomes (1)
Evolution of these markers over time
Comparison of data over time between cohorts (CL+ vs. CL-)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start6 Dec 2024
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID Long-HaulStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06528171
- Sponsor's protocol ID
- 23-RECHMIE-01
- Acronym
- CLIIM
- Status last verified
- Jun 2026
- First submitted
- 29 Jul 2024
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not planned
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Specific Markers of Covid-long Syndrome: Identifying the Mechanisms Involved With a View to Defining Diagnostic Criteria
- ClinicalTrials.gov ID
- NCT06528171
- Acronym / sponsor ID
- CLIIM / 23-RECHMIE-01
- Conditions
- COVID Long-Haul
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 6 Dec 2024 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 30 Jul 2024 (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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Covid-long (CL+) | Other | Procedure: Brain MRI, Biological: Specific blood samplesAssessment of musculoskeletal disorders, cognitive and neurocognitive assessments, Behavioral assessment, Work Difficulty Scale, Digital testing, brain MRI, Biological Analysis |
| Acute Covid (CL-) | Other | Procedure: Brain MRI, Biological: Specific blood samplesBrain MRI, Biological Analysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Case definition in line with WHO Delphi process
- 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).
Key exclusion criteria (9 listed)
- 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-)
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 |
|---|---|---|
| Brain MRInon injected brain MRI | Procedure or surgery | Acute Covid (CL-), Covid-long (CL+) |
| Specific blood samplesblood samples to find immunological and inflammatory markers | Biological | Acute Covid (CL-), Covid-long (CL+) |
Primary outcome
Predictive model of Covid-long
Time frame: 24 months
Build and validate a multivariate predictive model of Covid-long considering immunological, inflammatory and brain imaging markers.
1 secondary outcome
Evolution of these markers over time
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: No. Not planned
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brain MRI and Specific blood samples in people with COVID Long-Haul, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
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 3 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 22 Jun 2026. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michel CARLES, PhD (04 92 03 55 15, carles.m@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictive model of Covid-long (time frame: 24 months). 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 22 Jun 2026.