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NCT Number: NCT06528171

Covid-19 Long Immunité IMagerie (CLIIM)

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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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de NICE

Nice, 06200, France

Location status: Recruiting

Location contact

Michel CARLES, PhD

PRINCIPAL_INVESTIGATOR

TOUITOU Irit

CONTACT

[email protected]

04 92 03 58 47

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Brain MRI

Procedure

non injected brain MRI

Specific blood samples

Biological

blood samples to find immunological and inflammatory markers

Primary outcomes

  1. Predictive model of Covid-long

    Time frame: 24 months

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

Secondary outcomes

  1. Evolution of these markers over time

    Time frame: 24 months

    Comparison of data over time between cohorts (CL+ vs. CL-)

Study contacts

Contact information is provided by the study sponsor or research team.

Irit TOUITOU

CONTACT

[email protected]

04 92 03 58 47

Michel CARLES, PhD

CONTACT

[email protected]

04 92 03 55 15

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

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

Acronym: CLIIM

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Jul 30, 2024
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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