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SYNPOCov: Post-Covid Condition Cohort: Evolution of Symptomatology, Patient Profile and Associated Prognostic Factors

Sponsor
Central Hospital, Nancy, France (Other)
Overall Status
Recruiting
CT.gov ID
NCT05610436
Collaborator
(none)
500
Enrollment
1
Location
52.8
Anticipated Duration (Months)
9.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of our cohort is to collect prospectively, in a standardized and exhaustive manner, the health data of patients referred to the CAPCoV, our holistic referal post covid clinics for post-covid condition in order to be able to identify typical profiles of patients suffering from post covid syndrome and to follow the evolution of their disease over time.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Post-Covid Condition Monitoring Cohort: Evaluation of the Evolution of Symptomatology, Patient Profile and Associated Prognostic Factors
    Actual Study Start Date :
    Jan 7, 2022
    Anticipated Primary Completion Date :
    Dec 1, 2025
    Anticipated Study Completion Date :
    Jun 1, 2026

    Outcome Measures

    Primary Outcome Measures

    1. Symptoms [every 6 months up to 3 years]

      Symptoms collected in a standardized manner during consultations, their persistence over time, their evolution (improvement, stagnation, worsening) and their severity (mild, moderate, severe)

    Secondary Outcome Measures

    1. Medical history [baseline]

    2. fatigue [every 6 months up to 3 years]

      Chalder scale: range 0 to 33, >22/33 classified severe

    3. Dyspnea [every 6 months up to 3 years]

      mMRC

    4. Cognitive impairement [every 6 months up to 3 years]

      Montréal Cognitive Assessment : range 0 to 30, <26/30 classified pathologic

    5. inappropriate hyperventilation syndrome [every 6 months up to 3 years]

      Nijmegen score: range 0 to 64, >23/34 classified "possible inapropriate hyperventilation" syndrome"

    6. additional examinations [every 6 months up to 3 years]

      Biology, imaging

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • outpatients treated in the Nancy University Hospital Long Covid Support and Care Center for post-Covid condition according to WHO definition
    Exclusion Criteria:
    • patient opposing the processing for research purposes of their data collected in routine care for their care

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Nancy University Hospital Vandoeuvre les nancy Grand Est France 54511

    Sponsors and Collaborators

    • Central Hospital, Nancy, France

    Investigators

    • Principal Investigator: Francois GOEHRINGER, MD, Infectious Diseases Department, Nancy University Hospital,F-54000 Nancy, France.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    GOEHRINGER François, Principal Investigator, clinical physician, Infectious Diseases department, Central Hospital, Nancy, France
    ClinicalTrials.gov Identifier:
    NCT05610436
    Other Study ID Numbers:
    • 2022PI148
    First Posted:
    Nov 9, 2022
    Last Update Posted:
    Nov 9, 2022
    Last Verified:
    Oct 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    COVID-19

    Study Results

    No Results Posted as of Nov 9, 2022