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NCT Number: NCT07356570

Second Prospective Cohort of Patients Entering the Multidisciplinary Care Pathway for Post-Covid Syndromes - SyPoCo2 Cohort

The study aims to identify clinical profiles of long-COVID patients and correlate them with immunological and molecular data in order to identify prognostic biomarkers and potential therapeutic targets.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Service Pneumologie aigue spécialisée et cancérologie thoracique, Pierre-Bénite, France

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Documented SARS-CoV-2 infection
  • Persistent or complex post-COVID symptoms lasting more than 4 weeks or more than 3 months
  • Patient referred to the EPSILON pathway or to the post-COVID rehabilitation unit
  • Age ≥ 18 years
  • Non-institutionalized
  • Expected survival greater than 6 months

Exclusion criteria

  • Refusal to participate or to share data
  • Uncontrolled comorbidities
  • Pregnant or breastfeeding women
  • Persons under legal protection or deprived of liberty
  • Not affiliated with the French national health insurance system

Treatment and study plan

Blood Sample Collection

Other

A one-time 30 mL blood draw is performed during the inclusion visit for immunological and molecular analysis as part of the HERVCOV research program. No therapeutic intervention is administered, and no samples are stored after analysis.

Primary outcomes

  1. Number of participants per clinical cluster at Day 0 (clusters derived from unsupervised multivariate analysis of clinical and paraclinical variables).

    Time frame: At inclusion (Day 0), single time point

    At inclusion (Day 0), participants' clinical and paraclinical data will be collected and standardized (z-scores) to derive clinical clusters using unsupervised multivariate methods (principal component analysis for dimensionality reduction if needed, followed by k-means or hierarchical clustering with Euclidean distance).

Secondary outcomes

  1. Differences in clinical and biological parameters between patient subgroups defined by symptom profile and time since initial infection

    Time frame: At inclusion (Day 0)

    atients will be classified into subgroups according to the predominant type and severity of post-COVID symptoms (e.g., fatigue-dominant, cognitive, respiratory) and the interval since acute SARS-CoV-2 infection (<12 months, ≥12 months). Comparative analyses will assess differences in clinical scores (e.g., fatigue, quality of life), and biological markers (e.g., inflammatory cytokines, immune cell subsets) between groups.

  2. Concentration of residual SARS-CoV-2 viral proteins detected in plasma samples at inclusion

    Time frame: At inclusion (Day 0)

    Proteomic analyses (e.g., mass spectrometry, immunoassay) will be performed on plasma samples to quantify the presence of SARS-CoV-2 structural or non-structural proteins (e.g., spike, nucleocapsid).

  3. Serum biomarker concentrations at Day 0 by clinical cluster

    Time frame: Day 0

    Blood is collected at inclusion (Day 0). Each analyte concentration (pg/mL or ng/mL, as applicable) will be summarized per cluster as mean (SD) or median (IQR) and compared across clusters using ANOVA or Kruskal-Wallis with post-hoc tests as appropriate; effect sizes and 95% CIs will be reported.

  4. Association between clinical clusters and serum biomarker panel at Day 0 (standardized mean differences and multivariable models)

    Time frame: Day 0

    Cluster membership will be the exposure; each biomarker (standardized) will be the outcome in linear models adjusted for prespecified covariates (e.g., age, sex, time since first SARS-CoV-2 infection). the investigators will report adjusted differences (β) with 95% CIs and p-values; multiplicity will be handled

Study contacts

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

Sébastien Couraud, Pr

CONTACT

[email protected]

04 78 86 44 01 ext. +33

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: SYPOCO 2

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 21, 2026
Registry last updated
Jan 21, 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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