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

January 14, 2026 updated by: Hospices Civils de Lyon
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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Pierre-Bénite, France, 69 495
        • Recruiting
        • Service Pneumologie aigue spécialisée et cancérologie thoracique
        • Contact:
      • Saint-Genis-Laval, France, 69230
        • Recruiting
        • Hôpital Henry Gabrielle-HCL
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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).
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).
At inclusion (Day 0), single time point

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
At inclusion (Day 0)
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).
At inclusion (Day 0)
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.
Day 0
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
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 13, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 12, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 21, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 21, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 69HCL24_0943
  • IDRCB (Other Identifier: 2025-A02589-40)

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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