Covid-19 Long Immunité IMagerie (CLIIM)

NCT06528171 | Recruiting

• 1 other identifier: 23-RECHMIE-01
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID Long-Haul

Outcome Measures

Primary Outcomes (1)

• Predictive model of Covid-long

  Build and validate a multivariate predictive model of Covid-long considering immunological, inflammatory and brain imaging markers.

  24 months

Secondary Outcomes (1)

• Evolution of these markers over time

  24 months

Study Arms (2)

Covid-long (CL+)

OTHER

Assessment of musculoskeletal disorders, cognitive and neurocognitive assessments, Behavioral assessment, Work Difficulty Scale, Digital testing, brain MRI, Biological Analysis

Procedure: Brain MRI; Biological: Specific blood samples

Acute Covid (CL-)

OTHER

Brain MRI, Biological Analysis

Procedure: Brain MRI; Biological: Specific blood samples

Interventions

Brain MRI PROCEDURE

non injected brain MRI

Acute Covid (CL-); Covid-long (CL+)

Specific blood samples BIOLOGICAL

blood samples to find immunological and inflammatory markers

Acute Covid (CL-); Covid-long (CL+)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Case definition in line with WHO Delphi process

You may not qualify if:

• 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-)
• Absence of persistent symptoms more than 3 months after first Covid symptoms (or mild not affecting daily activities).
• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de NICE

Nice, 06200, France

RECRUITING

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Michel CARLES, PhD

CONTACT

04 92 03 55 15; carles.m@chu-nice.fr

Irit TOUITOU

CONTACT

04 92 03 58 47; touitou.i@chu-nice.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: July 30, 2024
• Study Start: December 6, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)