Recruiting NCT07356570
Second Prospective Cohort of Patients Entering the Multidisciplinary Care Pathway for Post-Covid Syndromes - SyPoCo2 Cohort
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blood sample collection.
- Who it may be relevant to
- Registry conditions: Post-Acute COVID-19 Syndrome. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- 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.
Primary outcome measures
- 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]
Secondary outcome measures (4)
- Differences in clinical and biological parameters between patient subgroups defined by symptom profile and time since initial infection [Time frame: At inclusion (Day 0)]
- Concentration of residual SARS-CoV-2 viral proteins detected in plasma samples at inclusion [Time frame: At inclusion (Day 0)]
- Serum biomarker concentrations at Day 0 by clinical cluster [Time frame: Day 0]
- Association between clinical clusters and serum biomarker panel at Day 0 (standardized mean differences and multivariable models) [Time frame: Day 0]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 2 centers
- Service Pneumologie aigue spécialisée et cancérologie thoracique — Pierre-Bénite
- Hôpital Henry Gabrielle-HCL — Saint-Genis-Laval
Identifiers
NCT: NCT07356570 · 69HCL24_0943 · IDRCB