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GERIA-COVID: Elucidating the Symptomatic, Explanatory and Prognostic Characteristics of GERIAtric Patients Hospitalized for COVID-19

Sponsor
University Hospital, Angers (Other)
Overall Status
Recruiting
CT.gov ID
NCT04560608
Collaborator
(none)
700
Enrollment
1
Location
33.5
Anticipated Duration (Months)
20.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Statement :

  • The emerging Coronavirus 2019 (COVID-19) disease, linked to the SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) pathogen, has been spreading worldwide since December 2019, affecting millions of people and causing hundreds of thousands of deaths, particularly among the elderly.

  • The first epidemiological evidence available reveals a different expression of the disease in the elderly, associated with a high risk of delayed diagnosis and implementation of protective measures and a particularly high morbidity and mortality, especially among the frailest.

  • To date, there is no effective model for predicting the severity of COVID-19 in an individual.

The investigators hypothesize that there are specificities of COVID-19 in the elderly, both etiological, diagnostic and prognostic, all of which are not yet known and understood.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    700 participants
    Observational Model:
    Cohort
    Time Perspective:
    Other
    Official Title:
    Elucidating the Symptomatic, Explanatory and Prognostic Characteristics of GERIAtric Patients Hospitalized for COVID-19
    Actual Study Start Date :
    Mar 15, 2020
    Anticipated Primary Completion Date :
    Dec 31, 2022
    Anticipated Study Completion Date :
    Dec 31, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Medical history and co-morbidities [baseline]

      listing of medical history and co-morbidities data provided by the physician and the family during hospitalization

    2. The physical examination data, and reports of relevant investigations data provided by the physician and the family during hospitalization [baseline]

      The demographic characteristics are age, sex, marital status, place of life, career, presence of un/formal assistance, …

    3. Electrocardiography QT Interval [baseline]

      all electrocardiograms performed during hospitalization

    4. Number of different therapeutic classes [baseline]

      Number of different therapeutic classes taken per day.

    5. Comprehensive Geriatric Assessment (CGA) [baseline]

      Comprehensive geriatric assessment (CGA) is defined as a multidisciplinary diagnostic and treatment process that identifies medical, psychosocial, and functional capabilities of an older adult in order to develop a coordinated plan to maximize overall health with aging. CGA is based on the premise that a systematic evaluation of frail older persons by a team of health professionals may identify a variety of treatable health problems and lead to better health outcomes.

    6. Biological parameters [baseline]

      Characterization of the COVID-19 impact on the biological parameters evaluated by blood test.

    7. Medical imaging results [baseline]

      Assessment of lesion extension (percent) with medical imaging results (thoracic scan)

    8. Diagnosis of COVID-19 [baseline]

      Recovery of the diagnosis method (PCR or thoracic scan)

    9. Length of hospitalization [at the 3-month follow-up]

    10. Number of death from any cause [at the 3-month follow-up]

    11. Reports of relevant investigations data provided by the physician and the family during the two-month telephone follow-up [at the 3-month follow-up]

      The demographic characteristics are age, sex, marital status, place of life, career, presence of un/formal assistance, …

    12. Length of hospitalization [at the 12-month follow-up]

    13. Number of death from any cause [at the 12-month follow-up]

    14. Reports of relevant investigations data provided by the physician and the family during the two-month telephone follow-up [at the 12-month follow-up]

      The demographic characteristics are age, sex, marital status, place of life, career, presence of un/formal assistance, …

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    70 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Hospitalization in the Geriatric unit of the University Hospital (UH) of Angers from 15/03/2020 and until the closure of the COVID-19 geriatric sector
    Exclusion Criteria:
    • Opposition to the use of the information collected for research purposes.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Angers University Hospital Angers France 49933

    Sponsors and Collaborators

    • University Hospital, Angers

    Investigators

    • Principal Investigator: Cédric ANNWEILER, MD, PhD, University Hospital, Angers

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Angers
    ClinicalTrials.gov Identifier:
    NCT04560608
    Other Study ID Numbers:
    • 2020/100
    • ar20-0087v0
    First Posted:
    Sep 23, 2020
    Last Update Posted:
    Dec 20, 2021
    Last Verified:
    Dec 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Angers
    elderly
    coronavirus disease
    Additional relevant MeSH terms:
    COVID-19

    Study Results

    No Results Posted as of Dec 20, 2021