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

Recruiting

• Conditions: Post-Covid Syndrome
• Interventions: Other: Blood collection

• Registration Number: NCT05805566
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-07
• Study First Submitted QC: 2023-04-07
• Study First Posted: 2023-04-10
• Study Start: 2023-04-27
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-26
• Last Update Posted: 2024-02-28
• Primary Completion: 2029-04
• Study Completion: 2029-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 750

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Post-Covid Syndrome Patients	Blood collection	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Biological analyses to find new molecular targets (biomarkers)	12 month	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).
Identify new research pathway to improve Post-Covid syndrome knowledge	12 month	Description of biological data and clinical and paraclinical data to determine the duration of the syndrome, refine the diagnosis and optimize future management.

Trial Locations

Locations (1)

Department of Acute Pneumology and Thoracic Oncology, Hôpital Lyon Sud, Hospices Civils de Lyon; 🇫🇷 Pierre-Bénite, France