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RecruitingNCT05805566SyPoCoUpdated Feb 28, 2024

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

An observational study in Post-Covid Syndrome, sponsored by Hospices Civils de Lyon. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-28.

Sponsored by Hospices Civils de Lyon · Observational

From the registry’s dates

  • Started Apr 2023; still recruiting 3 years 5 months later.
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
750
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Post-Covid Syndrome

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03

In context

Syndrome

9,217 studies on the registry are indexed under Syndrome; 1,031 are open to participants now.

This study's planned enrollment of 750 is above the median of 102 across 2,209 observational studies indexed under Syndrome.

Browse Syndrome studies →

Lead sponsor

Hospices Civils de Lyon is the lead sponsor of 1,826 studies on the registry; 439 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

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

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Other
Enrollment
750 participants (estimated)
Target follow-up
1 Year
Patient registry
Yes

Groups and cohorts

  • Post-Covid Syndrome Patients

    Other: Blood collection

Interventions

  • OtherBlood 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.

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What researchers measure

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.

    Time frame: Once a year

Secondary outcomes

  1. 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.

    Time frame: 12 month

  2. 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).

    Time frame: 12 month

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Study locations

1 of 1 sites recruiting
  • Department of Acute Pneumology and Thoracic Oncology, Hôpital Lyon Sud, Hospices Civils de Lyon
    Pierre-Bénite, 69495, France
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 28, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05805566
Lead sponsor
Hospices Civils de Lyon
Responsible party
Sponsor
First posted
Apr 10, 2023
Start date
Apr 27, 2023
Primary completion
Apr 2029 (estimated)
Completion
Apr 2029 (estimated)
Last update
Feb 28, 2024

Study contacts

Sébastien COURAUD, Pr
Contact
Sebastien.couraud@chu-lyon.fr
+33 (0)4 78 86 44 01
Julie DE BERMONT
Contact
Julie.de-bermont@chu-lyon.fr
+33 (0)4 78 86 66 98
Sébastien COURAUD, Pr
principal investigator · Department of Acute Pneumology and Thoracic Oncology, Hôpital Lyon Sud, Hospices Civils de Lyon

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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