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Clinical Trials/NCT05805566
NCT05805566
Recruiting
Not Applicable

Post-Covid Syndrome Cohort

Hospices Civils de Lyon1 site in 1 country750 target enrollmentApril 27, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Post-Covid Syndrome
Sponsor
Hospices Civils de Lyon
Enrollment
750
Locations
1
Primary Endpoint
Create a patient cohort
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 27, 2023
End Date
April 2029
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Exclusion Criteria

  • Patient refusing that this data to be used for research purposes (objection form).
  • Patient with untreated comorbidities

Outcomes

Primary Outcomes

Create a patient cohort

Time Frame: 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 Outcomes

  • Identify new research pathway to improve Post-Covid syndrome knowledge(12 month)
  • Biological analyses to find new molecular targets (biomarkers)(12 month)

Study Sites (1)

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