NCT05244343

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,096

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 25, 2022

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

February 16, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 17, 2022

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2022

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2022

Completed
Last Updated

April 1, 2022

Status Verified

March 1, 2022

Enrollment Period

1 month

First QC Date

February 16, 2022

Last Update Submit

March 21, 2022

Conditions

SARS CoV 2 InfectionCOVID-19

Keywords

COVID-19VaccinationHospitalization

Outcome Measures

Primary Outcomes (2)

  • Rate of COVID-19 not vaccinated patients hospitalized in ICU

    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

    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 Outcomes (3)

  • Rate of COVID-19 not vaccinated patients hospitalized in Medical Units

    From January 1st to February 15th

  • Rate of COVID-19 not fully vaccinated patients hospitalized in Medical Units

    From January 1st to February 15th

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

    From January 1st to February 15th

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • Subjects vaccinated outside Tunisia
  • Subjects \<18 years
  • Not confirmed COVID-19
  • Not hospitalized patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abderrahmen Mami Hospital

Aryanah, Tunisia

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Mariem Melliti

    Eshmoun Clinical Research Center

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2022

First Posted

February 17, 2022

Study Start

January 25, 2022

Primary Completion

March 3, 2022

Study Completion

March 10, 2022

Last Updated

April 1, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)