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

NCT05805566 | Recruiting

• 1 other identifier: 69HCL22_1053
• Study Type: observational
• Target: 750
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-Covid Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Identify new research pathway to improve Post-Covid syndrome knowledge

  12 month

• Biological analyses to find new molecular targets (biomarkers)

  12 month

Study Arms (1)

Post-Covid Syndrome Patients

Other: Blood collection

Interventions

Blood collection OTHER

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

Post-Covid Syndrome Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Department of Acute Pneumology and Thoracic Oncology, Hôpital Lyon Sud, Hospices Civils de Lyon

Pierre-Bénite, 69495, France

RECRUITING

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Sébastien COURAUD, Pr

  Department of Acute Pneumology and Thoracic Oncology, Hôpital Lyon Sud, Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sébastien COURAUD, Pr

CONTACT

+33 (0)4 78 86 44 01; Sebastien.couraud@chu-lyon.fr

Julie DE BERMONT

CONTACT

+33 (0)4 78 86 66 98; Julie.de-bermont@chu-lyon.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2023
• First Posted: April 10, 2023
• Study Start: April 27, 2023
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): April 1, 2029
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

FR (1)