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Clinical Trials/NCT05151094
NCT05151094
Active, Not Recruiting
N/A

Registry of Hospitalized Patients in University Hospital Dubrava Respiratory Center

University Hospital Dubrava1 site in 1 country6,000 target enrollmentApril 1, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Covid19
Sponsor
University Hospital Dubrava
Enrollment
6000
Locations
1
Primary Endpoint
Mortality
Status
Active, Not Recruiting
Last Updated
2 years ago

Overview

Brief Summary

Aim of this project is to understand clinical features, clinical outcomes and efficacy and safety profiles of different therapies by analyzing a cohort of COVID-19 patients hospitalized and treated in a tertiary-level institution, University hospital Dubrava. Patients' clinical and laboratory characteristics, drug exposure and outcomes are obtained by analysis of written and electronical medical records.

Detailed Description

University Hospital Dubrava has been completely repurposed during the COVID-19 pandemic to become high volume COVID-19 tertiary institution. Establishment of hospital registry project is necessary to properly understand disease characteristic, related outcomes and real-life treatment patterns. Registry provides a fundamental framework for future upgrading with emerging or retrogradely obtained specific data that will substantially facilitate understanding of COVID-19 in the context of other specific diseases, therapies and procedures. Large comprehensive database will provide sufficient statistical power to allow for investigation of large number of subgroups and existence of interactions between different variables. Assessment of large number of clinically important outcomes (mortality, occurrence of venous and arterial thromboses, major bleeding, bacteriemia, incidence of mechanical ventilation and intensive care unit admission) is necessary to put any investigated parameter in the proper efficacy and safety context.

Registry
clinicaltrials.gov
Start Date
April 1, 2021
End Date
January 1, 2026
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital Dubrava
Responsible Party
Principal Investigator
Principal Investigator

Marko Lucijanić

Study Director

University Hospital Dubrava

Eligibility Criteria

Inclusion Criteria

  • all hospitalized patients positive for COVID-19

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Mortality

Time Frame: At 30-days from hospital admission

Incidence of death from any cause

Secondary Outcomes

  • Incidence of mechanical ventilation(At 30-days from hospital admission)
  • Incidence of venous or arterial thrombotic events(At 30-days from hospital admission)
  • Incidence of major bleeding(At 30-days from hospital admission)
  • Incidence of intensive care unit admission(At 30-days from hospital admission)
  • Incidence of bacteriemia(At 30-days from hospital admission)

Study Sites (1)

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