Covid-19 Long Immunité IMagerie (CLIIM) (CLIIM)

May 12, 2025 updated by: Centre Hospitalier Universitaire de Nice

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Nice, France, 06200
        • Recruiting
        • CHU de Nice
        • Contact:
        • Principal Investigator:
          • Michel CARLES, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Covid-long (CL+)
Assessment of musculoskeletal disorders, cognitive and neurocognitive assessments, Behavioral assessment, Work Difficulty Scale, Digital testing, brain MRI, Biological Analysis
Procedure: Brain MRI
non injected brain MRI
Biological: Specific blood samples
blood samples to find immunological and inflammatory markers
Other: Acute Covid (CL-)
Brain MRI, Biological Analysis
Procedure: Brain MRI
non injected brain MRI
Biological: Specific blood samples
blood samples to find immunological and inflammatory markers

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evolution of these markers over time
Time Frame: 24 months
Comparison of data over time between cohorts (CL+ vs. CL-)
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nice

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 6, 2024

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

July 29, 2024

First Submitted That Met QC Criteria

July 29, 2024

First Posted (Actual)

July 30, 2024

Study Record Updates

Last Update Posted (Actual)

May 14, 2025

Last Update Submitted That Met QC Criteria

May 12, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 23-RECHMIE-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Not planned

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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