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Recruiting NCT06528171

Covid-19 Long Immunité IMagerie (CLIIM)

No phase Interventional COVID Long-Haul

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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Brain MRI, Specific blood samples.
Who it may be relevant to
Registry conditions: COVID Long-Haul. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Specific Markers of Covid-long Syndrome: Identifying the Mechanisms Involved With a View to Defining Diagnostic Criteria

Overview

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.

Interventions

  • Procedure Brain MRI
    non injected brain MRI
  • Biological Specific blood samples
    blood samples to find immunological and inflammatory markers

Primary outcome measures

  • Predictive model of Covid-long [Time frame: 24 months]
Secondary outcome measures (1)
  • Evolution of these markers over time [Time frame: 24 months]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Diagnostic

Study locations

France · 1 center
  • CHU de NICE — Nice

Identifiers

NCT: NCT06528171 · 23-RECHMIE-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗