Covid-19 Long Immunité IMagerie (CLIIM)

Not Applicable

Recruiting

• Conditions: COVID Long-Haul
• Interventions: Procedure: Brain MRI; Biological: Specific blood samples

• Registration Number: NCT06528171
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-29
• Study First Submitted QC: 2024-07-29
• Study First Posted: 2024-07-30
• Study Start: 2024-12-06
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-14
• Primary Completion: 2025-12
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acute Covid (CL-)	Specific blood samples	Brain MRI, Biological Analysis
Covid-long (CL+)	Brain MRI	Assessment of musculoskeletal disorders, cognitive and neurocognitive assessments, Behavioral assessment, Work Difficulty Scale, Digital testing, brain MRI, Biological Analysis
Acute Covid (CL-)	Brain MRI	Brain MRI, Biological Analysis
Covid-long (CL+)	Specific blood samples	Assessment of musculoskeletal disorders, cognitive and neurocognitive assessments, Behavioral assessment, Work Difficulty Scale, Digital testing, brain MRI, Biological Analysis

Primary Outcome Measures

Name	Time	Method
Predictive model of Covid-long	24 months	Build and validate a multivariate predictive model of Covid-long considering immunological, inflammatory and brain imaging markers.

Secondary Outcome Measures

Name	Time	Method
Evolution of these markers over time	24 months	Comparison of data over time between cohorts (CL+ vs. CL-)

Trial Locations

Locations (1)

CHU de NICE; 🇫🇷 Nice, France