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NCT Number: NCT05805566

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

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.

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Key information

Conditions

Post-COVID Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Pierre-Bénite, 69495, France

Location status: Recruiting

Location contact

Sébastien COURAUD, Pr

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Create a patient cohort

    Time frame: Once a year

    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.

Secondary outcomes

  1. Identify new research pathway to improve Post-Covid syndrome knowledge

    Time frame: 12 month

    Description of biological data and clinical and paraclinical data to determine the duration of the syndrome, refine the diagnosis and optimize future management.

  2. Biological analyses to find new molecular targets (biomarkers)

    Time frame: 12 month

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Julie DE BERMONT

CONTACT

[email protected]

+33 (0)4 78 86 66 98

Sébastien COURAUD, Pr

CONTACT

[email protected]

+33 (0)4 78 86 44 01

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Post-Covid Syndrome Cohort

Acronym: SyPoCo

Important dates

Study start
2023
Primary completion
2029
Study completion
2029
First posted
Apr 10, 2023
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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