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.
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.
Study Type
OBSERVATIONAL
Enrollment
6,000
Observation of clinical outcomes and comparison to non-treated patients
University Hospital Dubrava
Zagreb, City of Zagreb, Croatia
Mortality
Incidence of death from any cause
Time frame: At 30-days from hospital admission
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.
Time frame: At 30-days from hospital admission
Incidence of major bleeding
Incidence of bleeding events that can be classified by the International Society on Thrombosis and Haemostasis criteria as major bleeding.
Time frame: At 30-days from hospital admission
Incidence of bacteriemia
Incidence of positive blood cultures that were taken based on clinical suspicion for bacterial co-infection.
Time frame: At 30-days from hospital admission
Incidence of mechanical ventilation
Incidence of mechanical ventilation use required for deteriorating respiratory function.
Time frame: At 30-days from hospital admission
Incidence of intensive care unit admission
Incidence of intensive care unit admission required for intensive/critical level of care.
Time frame: At 30-days from hospital admission
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