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Recruiting NCT05805566

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

Observational Post-Covid Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Blood collection.
Who it may be relevant to
Registry conditions: Post-Covid Syndrome. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Post-Covid Syndrome Cohort

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Create a patient cohort [Time frame: Once a year]
Secondary outcome measures (2)
  • Identify new research pathway to improve Post-Covid syndrome knowledge [Time frame: 12 month]
  • Biological analyses to find new molecular targets (biomarkers) [Time frame: 12 month]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • Department of Acute Pneumology and Thoracic Oncology, Hôpital Lyon Sud, Hospices Civils de — Pierre-Bénite

Identifiers

NCT: NCT05805566 · 69HCL22_1053

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗