I VACCIN Hospitalization of COVID-19 Patients

March 21, 2022 updated by: Eshmoun Clinical Research Center

Impact of Vaccination on Medical and Intensive Care Hospitalization of COVID-19 Patients

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

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

1096

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Tunisia
      • Ariana, Tunisia
        • Abderrahmen Mami Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients hospitalized due to COVID-19 in ICU or medical units, who are ≥ 18 years old during the period extended from January 1st to March 3rd.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of COVID-19 not vaccinated patients hospitalized in ICU
Time Frame: 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
From January 1st to February 15th
Rate of COVID-19 not fully vaccinated patients hospitalized in ICU
Time Frame: 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
From January 1st to February 15th

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of COVID-19 not vaccinated patients hospitalized in Medical Units
Time Frame: 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
From January 1st to February 15th
Rate of COVID-19 not fully vaccinated patients hospitalized in Medical Units
Time Frame: 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
From January 1st to February 15th
Rate of COVID-19 vaccinated patients hospitalized in Medical Unit by type of vaccine
Time Frame: From January 1st to February 15th
Rate of COVID-19 vaccinated patients hospitalized in Medical Unit by type of vaccine received
From January 1st to February 15th

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eshmoun Clinical Research Center

Investigators

  • Study Director: Mariem Melliti, Eshmoun Clinical Research Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 25, 2022

Primary Completion (Actual)

March 3, 2022

Study Completion (Actual)

March 10, 2022

Study Registration Dates

First Submitted

February 16, 2022

First Submitted That Met QC Criteria

February 16, 2022

First Posted (Actual)

February 17, 2022

Study Record Updates

Last Update Posted (Actual)

April 1, 2022

Last Update Submitted That Met QC Criteria

March 21, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • I VACCIN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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