Covid-19 Long Immunité IMagerie (CLIIM)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-06

Study Completion Date

2026-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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COVID Long-Haul

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Covid-long (CL+)

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

Group Type OTHER

Brain MRI

Intervention Type PROCEDURE

non injected brain MRI

Specific blood samples

Intervention Type BIOLOGICAL

blood samples to find immunological and inflammatory markers

Acute Covid (CL-)

Brain MRI, Biological Analysis

Group Type OTHER

Brain MRI

Intervention Type PROCEDURE

non injected brain MRI

Specific blood samples

Intervention Type BIOLOGICAL

blood samples to find immunological and inflammatory markers

Interventions

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Brain MRI

non injected brain MRI

Intervention Type PROCEDURE

Specific blood samples

blood samples to find immunological and inflammatory markers

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* 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).

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-)

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes