SyPoCo: Retrospective and Prospective Cohort of Patients Entering the Multidisciplinary Management of Post-Covid Syndromes

Sponsor
Hospices Civils de Lyon (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05805566
Collaborator
(none)
750
1
47
16

Study Details

Study Description

Brief Summary

SARS-CoV2 pneumonia has been a global public health emergency since 2020. The prevalence of the disease is particularly high with more than 500 million cases worldwide (7.5 million in France) since the emergence of the virus.

A substantial proportion of patients with SARS-Cov2 infection present persistent symptoms long after the acute infection. This is independent of the degree of severity of the SARS-Cov2 infection.

These symptoms can affect the quality of life and impede the return to work. While the majority of symptoms progress favourably with outpatient care, some persist and/or are particularly severe, justifying expert and multidisciplinary care.

This investigation aim to create a clinical database of patients with complex and/or severe post-CoviD and study blood markers what could predict the disease and orientate new ways of treatment.

Condition or Disease Intervention/Treatment Phase
  • Other: Blood collection

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
750 participants
Observational Model:
Cohort
Time Perspective:
Other
Official Title:
Post-Covid Syndrome Cohort
Anticipated Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Mar 1, 2027
Anticipated Study Completion Date :
Mar 1, 2027

Arms and Interventions

Arm Intervention/Treatment
Post-Covid Syndrome Patients

Other: Blood collection
Blood samples will be collected from the patient at baseline. This blood will be collected during the standard of care blood drawing in extra.

Outcome Measures

Primary Outcome Measures

  1. Create a patient cohort [Once a year]

    Creation of a retrospective and prospective cohort combining: Collection of clinical and paraclinical data, scores, and scales. Prospective monitoring of quality of life, other scores as needed. Cross-referencing of clinical data with the results of cellular and molecular analyzes on lymphocytes blood cells, which will be carried out (part carried out by Inserm). by INSERM U1111 as part of the European HERVCOV project.

Secondary Outcome Measures

  1. Find new research pathway to improve Post-Covid syndrome knowledge [Once a year]

    Evaluate the biological data and clinical and paraclinical data to determine the duration of the syndrome, refine the diagnosis and optimize future management.

  2. Biological analyses to find new molecular targets (biomarkers) [Once a year]

    Biological analyzes of blood constituents for the detection of molecular and/or cellular modifications, which could be at the origin of the symptoms (Carried out by Inserm).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

All patients who have joined the Epsilon care pathway since its opening in February 2022, i.e.:

  • Patients with post-Covid syndrome referred to the Epsilon sector from the city medicine:

  • Patient with documented SARS-Cov2 pneumonia

  • With persistent and severe symptoms beyond 4 weeks or complex or disabling symptoms beyond 3 months

  • Patient over 18 years old.

Post-hospital sector:
  • Patient with documented SARS-Cov2 pneumonia

  • Hospitalized for oxygen therapy (at least 48h)

  • Not having a referring pulmonologist

  • Not institutionalized

  • With a life expectancy of more than 6 months.

Exclusion Criteria:
  • Patient refusing that this data to be used for research purposes (objection form).

  • Patient with untreated comorbidities

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Acute Pneumology and Thoracic Oncology, Hôpital Lyon Sud, Hospices Civils de Lyon Pierre-Bénite France 69495

Sponsors and Collaborators

  • Hospices Civils de Lyon

Investigators

  • Principal Investigator: Sébastien COURAUD, Pr, Department of Acute Pneumology and Thoracic Oncology, Hôpital Lyon Sud, Hospices Civils de Lyon

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT05805566
Other Study ID Numbers:
  • 69HCL22_1053
First Posted:
Apr 10, 2023
Last Update Posted:
Apr 10, 2023
Last Verified:
Apr 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 10, 2023