Second Prospective Cohort of Patients Entering the Multidisciplinary Care Pathway for Post-Covid Syndromes - SyPoCo2 Cohort (SYPOCO 2)

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.

Study Overview

• Status: Recruiting
• Conditions: Post-Acute COVID-19 Syndrome
• Intervention / Treatment: Other: Blood sample collection

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Sébastien COURAUD, Pr; Phone Number: +33 04 78 86 44 01; Email: Sebastien.couraud@chu-lyon.fr

Study Locations

• France
  • Pierre-Bénite, France, 69 495
    • Recruiting
    • Service Pneumologie aigue spécialisée et cancérologie thoracique
    • Contact: Sébastien COURAUD, Pr; Phone Number: +33 04 78 86 44 01; Email: Sebastien.couraud@chu-lyon.fr
  • Saint-Genis-Laval, France, 69230
    • Recruiting
    • Hôpital Henry Gabrielle-HCL
    • Contact: Sophie JACQUIN COURTOIS, Dr; Phone Number: +33 04.78.86.50.69; Email: Sophie.courtois@chu-lyon.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

his study involves adult patients (≥18 years) with documented SARS-CoV-2 infection referred to a multidisciplinary post-COVID care pathway. Participants present persistent or complex symptoms beyond 4 weeks or 3 months. Recruitment occurs at Hôpital Henry Gabrielle (rehabilitation unit) and Hôpital Lyon Sud (pulmonology department). Patients are enrolled during their regular clinical follow-up. Clinical and biological data are collected at a single inclusion visit.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Post-COVID Patient Cohort; Patients aged ≥18 years with documented SARS-CoV-2 infection and persistent or complex symptoms beyond 4 weeks or 3 months. Participants are referred to either the post-COVID rehabilitation program at Hôpital Henry Gabrielle or the EPSILON pathway at Hôpital Lyon Sud. Clinical and biological data are collected at a single inclusion visit.	Other: Blood sample collection; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants per clinical cluster at Day 0 (clusters derived from unsupervised multivariate analysis of clinical and paraclinical variables).	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).	At inclusion (Day 0), single time point

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differences in clinical and biological parameters between patient subgroups defined by symptom profile and time since initial infection	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.	At inclusion (Day 0)
Concentration of residual SARS-CoV-2 viral proteins detected in plasma samples at inclusion	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).	At inclusion (Day 0)
Serum biomarker concentrations at Day 0 by clinical cluster	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.	Day 0
Association between clinical clusters and serum biomarker panel at Day 0 (standardized mean differences and multivariable models)	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	Day 0

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: June 12, 2025
• First Submitted That Met QC Criteria: January 14, 2026
• First Posted (Actual): January 21, 2026

Study Record Updates

• Last Update Posted (Actual): January 21, 2026
• Last Update Submitted That Met QC Criteria: January 14, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: SARS-CoV-2; Biomarkers; Long COVID; Post-COVID syndrome; Immune response; Prospective cohort
• Additional Relevant MeSH Terms: Post-Infectious Disorders; COVID-19; Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; Pathological Conditions, Signs and Symptoms; Post-Acute COVID-19 Syndrome
• Other Study ID Numbers: 69HCL24_0943; IDRCB (Other Identifier: 2025-A01568-41)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No