Covid-19 Long Immunité IMagerie (CLIIM)

Centre Hospitalier Universitaire de Nice

Status: Enrolling

Conditions: COVID Long-Haul

Treatments: Biological: Specific blood samples; Procedure: Brain MRI

Study type: Interventional

Funder types: Other

Identifiers

NCT06528171

23-RECHMIE-01

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Covid-long (CL+)

Other group

Description:

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

Treatment:

Procedure: Brain MRI

Biological: Specific blood samples

Acute Covid (CL-)

Other group

Description:

Brain MRI, Biological Analysis

Treatment:

Procedure: Brain MRI

Biological: Specific blood samples