Clincosm LogoSign in Get a demo

COVIDGHPSJCite: Become of Patients Infected or Suspected of Being Infected by Covid-19 and Supported by the GHPSJ and the Establishments of the Paris Plaisance Hospital City

Sponsor
Groupe Hospitalier Paris Saint Joseph (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04365530
Collaborator
(none)
3,767
Enrollment
5
Locations
33
Anticipated Duration (Months)
753.4
Patients Per Site
22.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The ongoing Coronavirus (Covid-19) pandemic is causing a major global health crisis and is shaking up hospital organizations. To date, the recognized risk factors for severe forms of Covid-19 infection are elderly patients (> 70 years), obese patients, patients with chronic renal or respiratory pathologies, cardiovascular history (stroke or coronary artery disease), chronic respiratory conditions, high blood pressure, diabetes, and cancer. Covid-19 is manifested by a risk of acute respiratory distress syndrome requiring management by invasive ventilation. The lethality of this infection is around 4% in the current data.

Drastic precautionary measures for the transmission of the virus, as well as the provision of critical care beds by canceling any scheduled non-urgent intervention or consultation, have shaken up the hospital organization.

In this context, it is essential to have forward-looking data in real time to adjust the care offer and better understand the impact of Covid-19 on the patient populations treated.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    3767 participants
    Observational Model:
    Cohort
    Time Perspective:
    Other
    Official Title:
    Become of Patients Infected or Suspected of Being Infected by Covid-19 and Supported by the GHPSJ and the Establishments of the Paris Plaisance Hospital City
    Actual Study Start Date :
    Apr 1, 2020
    Actual Primary Completion Date :
    Jun 30, 2022
    Anticipated Study Completion Date :
    Dec 31, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Clinical consequences of a Covid-19 infection in the care population [Year 2]

      This outcome measures the clinical consequences of a Covid-19 infection in the care population.

    Secondary Outcome Measures

    1. Risk factors at M6 [Month 6]

      This outcome evaluates the risk factors of COVID-19 at month 6

    2. Risk factors at year 1 [Year 1]

      This outcome evaluates the risk factors of COVID-19.

    3. Risk factors at year 2 [Year 2]

      This outcome evaluates the risk factors of COVID-19.

    4. Impact of hospital reorganization on medical care at M6 [Month 6]

      This outcome evaluates the impact of hospital reorganization on medical care at month 6.

    5. Impact of hospital reorganization on medical care at Year 1 [Year 1]

      This outcome evaluates the impact of hospital reorganization on medical care at year 1.

    6. Impact of hospital reorganization on medical care at Year 2 [Year 2]

      This outcome evaluates the impact of hospital reorganization on medical care at year 2.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patient (of all ages) with symptoms compatible with infection by Covid-19 treated at the GHPSJ or in one of the establishments in the Paris Plaisance hospital city.
    Exclusion Criteria:

    • Asymptomatic patient

    • Patient objecting to the use of their data

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hôpital Marie Lannelongue Le Plessis-Robinson France 92350
    2 AURA Paris Plaisance Paris France 75014
    3 Fondation Sainte-Marie Paris France 75014
    4 Groupe Hospitalier Paris Saint-Joseph Paris France 75014
    5 Hôpital Bellan Paris France 75014

    Sponsors and Collaborators

    • Groupe Hospitalier Paris Saint Joseph

    Investigators

    • Principal Investigator: Benoit PILMIS, MD, Groupe Hospitalier Paris Saint Joseph

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Groupe Hospitalier Paris Saint Joseph
    ClinicalTrials.gov Identifier:
    NCT04365530
    Other Study ID Numbers:
    • Cohorte COVID GHPSJ CiteH
    First Posted:
    Apr 28, 2020
    Last Update Posted:
    Aug 18, 2022
    Last Verified:
    Jun 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Aug 18, 2022