Clinical trial NCT05805566: Retrospective and Prospective Cohort of Patients Entering the Multidisciplinary Management of Post-Covid Syndromes
Official title: Post-Covid Syndrome Cohort
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Post-Covid Syndrome
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2023-04-10
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

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.


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
* 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

Primary outcomes:
measure: Create a patient cohort
timeFrame: Once a year
Secondary outcomes:
measure: Identify new research pathway to improve Post-Covid syndrome knowledge
timeFrame: 12 month
measure: Biological analyses to find new molecular targets (biomarkers)
timeFrame: 12 month
Other outcomes:
Locations:
city: Pierre-Bénite
country: France
facility: Department of Acute Pneumology and Thoracic Oncology, Hôpital Lyon Sud, Hospices Civils de Lyon
Study officials:
affiliation: Department of Acute Pneumology and Thoracic Oncology, Hôpital Lyon Sud, Hospices Civils de Lyon
name: Sébastien COURAUD, Pr
role: PRINCIPAL_INVESTIGATOR
References: