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

NCT07356570 | Recruiting

• 2 other identifiers: 69HCL24_0943IDRCB
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Post-Acute COVID-19 Syndrome

Keywords

Long COVID; SARS-CoV-2; Post-COVID syndrome; Immune response; Biomarkers; Prospective cohort

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

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

  At inclusion (Day 0)

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

  At inclusion (Day 0)

• Serum biomarker concentrations at Day 0 by clinical cluster

  Day 0

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

  Day 0

Study Arms (1)

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

Interventions

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.

Post-COVID Patient Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (2)

Service Pneumologie aigue spécialisée et cancérologie thoracique

Pierre-Bénite, 69 495, France

RECRUITING

Hôpital Henry Gabrielle-HCL

Saint-Genis-Laval, 69230, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood samples (30 mL total per patient) will be collected during the inclusion visit: 2 SST tubes (5 mL) and 2 EDTA tubes (10 mL). Samples will be processed for immunological and molecular analyses at Inserm U1111 (CIRI, Lyon) and Inserm We-Met (I2MC, Toulouse). All samples will be pseudonymized. No biological specimens will be stored or banked after analysis. DNA and RNA will not be used to identify or re-identify participants. No biobank or collection is created as part of this study.

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Sébastien Couraud, Pr

CONTACT

04 78 86 44 01; Sebastien.couraud@chu-lyon.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2025
• First Posted: January 21, 2026
• Study Start: June 13, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 21, 2026

Record last verified: 2026-01

Locations

FR (2)