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

Post-Covid Syndrome Cohort

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.

Study Overview

• Status: Recruiting
• Conditions: Post-Covid Syndrome
• Intervention / Treatment: Other: Blood collection

• Study Type: Observational
• Enrollment (Estimated): 750

Contacts and Locations

• Study Contact: Name: Sébastien COURAUD, Pr; Phone Number: +33 (0)4 78 86 44 01; Email: Sebastien.couraud@chu-lyon.fr
• Study Contact Backup: Name: Julie DE BERMONT; Phone Number: +33 (0)4 78 86 66 98; Email: Julie.de-bermont@chu-lyon.fr

Study Locations

• France
  • Pierre-Bénite, France, 69495
    • Recruiting
    • Department of Acute Pneumology and Thoracic Oncology, Hôpital Lyon Sud, Hospices Civils de Lyon
    • Contact: Sébastien COURAUD, Pr; Email: sebastien.couraud@chu-lyon.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This study will focus on adult patients with SARS COV2 whose symptoms persist beyond 4 weeks after the acute phase and who will have integrated the Epsilon care system in the pneumology department of Lyon Sud Hospital.

It is difficult to define an exact number of subjects because this syndrome is still poorly characterized.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Create a patient cohort	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.	Once a year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: 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 record dates

Study Major Dates

• Study Start (Actual): April 27, 2023
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): April 1, 2029

Study Registration Dates

• First Submitted: April 7, 2023
• First Submitted That Met QC Criteria: April 7, 2023
• First Posted (Actual): April 10, 2023

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Syndrome
• Other Study ID Numbers: 69HCL22_1053

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No