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I VACCIN Hospitalization of COVID-19 Patients

Sponsor
Eshmoun Clinical Research Center (Other)
Overall Status
Completed
CT.gov ID
NCT05244343
Collaborator
(none)
1,096
Enrollment
1
Location
1.4
Actual Duration (Months)
758.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A REALLIFE evaluation of rate of hospitalized patients in Intensive Care Units and in medical Units of non -vaccinated patients vs vaccinated patients

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Transversal National multicenter non interventional on the COVID-19 vaccines

    • Period of hospitalization: from January 1st to March 3rd, 2022

    • Recruitment duration: 37 days

    • Total study duration: 44 days

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    1096 participants
    Observational Model:
    Other
    Time Perspective:
    Cross-Sectional
    Official Title:
    Impact of Vaccination on Medical and Intensive Care Hospitalization of COVID-19 Patients
    Actual Study Start Date :
    Jan 25, 2022
    Actual Primary Completion Date :
    Mar 3, 2022
    Actual Study Completion Date :
    Mar 10, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Rate of COVID-19 not vaccinated patients hospitalized in ICU [From January 1st to February 15th]

      Rate of non vaccinated patients who were hospitalized in ICU due to COVID-19 compared to all patients hospitalized due to COVID-19

    2. Rate of COVID-19 not fully vaccinated patients hospitalized in ICU [From January 1st to February 15th]

      Rate of not fully vaccinated patients who were hospitalized in ICU due to COVID-19 compared to the total number of Hospitalized patients

    Secondary Outcome Measures

    1. Rate of COVID-19 not vaccinated patients hospitalized in Medical Units [From January 1st to February 15th]

      Rate of non vaccinated patients who were hospitalized in Medical units due to COVID-19 compared to all patients hospitalized due to COVID-19

    2. Rate of COVID-19 not fully vaccinated patients hospitalized in Medical Units [From January 1st to February 15th]

      Rate of not fully vaccinated patients who were hospitalized in Medical units due to COVID-19 compared to all patients hospitalized due to COVID-19

    3. Rate of COVID-19 vaccinated patients hospitalized in Medical Unit by type of vaccine [From January 1st to February 15th]

      Rate of COVID-19 vaccinated patients hospitalized in Medical Unit by type of vaccine received

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Male and Female ≥ 18 years

    • Confirmed COVID-19 patients hospitalized in ICU and Medical Units during the period of the study from January 1st to March 3rd.

    Exclusion Criteria:

    • Subjects vaccinated outside Tunisia

    • Subjects <18 years

    • Not confirmed COVID-19

    • Not hospitalized patients

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Abderrahmen Mami Hospital Ariana Tunisia

    Sponsors and Collaborators

    • Eshmoun Clinical Research Center

    Investigators

    • Study Director: Mariem Melliti, Eshmoun Clinical Research Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eshmoun Clinical Research Center
    ClinicalTrials.gov Identifier:
    NCT05244343
    Other Study ID Numbers:
    • I VACCIN
    First Posted:
    Feb 17, 2022
    Last Update Posted:
    Apr 1, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Eshmoun Clinical Research Center
    COVID-19
    Vaccination
    Hospitalization
    Additional relevant MeSH terms:
    COVID-19

    Study Results

    No Results Posted as of Apr 1, 2022