Registry of Hospitalized Patients in University Hospital Dubrava Respiratory Center

Covid19 Clinical Trial

— COVID-19  

Official title:

Registry of Hospitalized Patients in University Hospital Dubrava Respiratory Center

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05151094
• Other study ID #: 2021/2503-04
• Status: Active, not recruiting
• Start date: April 1, 2021
• Est. completion date: January 1, 2026

Study information

• Verified date: May 2023
• Source: University Hospital Dubrava
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 6000
• Est. completion date: January 1, 2026
• Est. primary completion date: January 1, 2026
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• all hospitalized patients positive for COVID-19

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Bleeding
• Covid19
• Inflammatory Response
• Mechanical Ventilation Complication
• Sepsis
• Thrombosis

Intervention

Other:
• Observation
Observation of clinical outcomes and comparison to non-treated patients

Locations

Country	Name	City	State
Croatia	University Hospital Dubrava	Zagreb	Grad Zagreb

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Dubrava

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	Incidence of death from any cause	At 30-days from hospital admission
Secondary	Incidence of venous or arterial thrombotic events	Incidence of arterial or venous thromboses proven by objective imaging (ultrasound, computerized tomography, magnetic resonance imaging, scintigraphy) and laboratory (troponin) methods.	At 30-days from hospital admission
Secondary	Incidence of major bleeding	Incidence of bleeding events that can be classified by the International Society on Thrombosis and Haemostasis criteria as major bleeding.	At 30-days from hospital admission
Secondary	Incidence of bacteriemia	Incidence of positive blood cultures that were taken based on clinical suspicion for bacterial co-infection.	At 30-days from hospital admission
Secondary	Incidence of mechanical ventilation	Incidence of mechanical ventilation use required for deteriorating respiratory function.	At 30-days from hospital admission
Secondary	Incidence of intensive care unit admission	Incidence of intensive care unit admission required for intensive/critical level of care.	At 30-days from hospital admission