Registry of Hospitalized Patients in University Hospital Dubrava Respiratory Center

Study Overview
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Brief Summary
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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
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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.

Official Title
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Registry of Hospitalized Patients in University Hospital Dubrava Respiratory Center

Conditions
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Covid19, Sepsis, Thrombosis, Bleeding, Mechanical Ventilation Complication, Inflammatory Response

Intervention / Treatment
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* Other: Observation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: all hospitalized patients positive for COVID-19 Exclusion Criteria: none
Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Remdesivir exposure<br>Patients treated with remdesivir due to the COVID-19 infection | Other: Observation<br>* Observation of clinical outcomes and comparison to non-treated patients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Incidence of death from any cause | At 30-days from hospital admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| Incidence of mechanical ventilation | Incidence of mechanical ventilation use required for deteriorating respiratory function. | 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. | At 30-days from hospital admission |