COVID-19: Registry of Hospitalized Patients in University Hospital Dubrava Respiratory Center
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Remdesivir exposure Patients treated with remdesivir due to the COVID-19 infection |
Other: Observation
Observation of clinical outcomes and comparison to non-treated patients
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Outcome Measures
Primary Outcome Measures
- Mortality [At 30-days from hospital admission]
Incidence of death from any cause
Secondary Outcome Measures
- Incidence of venous or arterial thrombotic events [At 30-days from hospital admission]
Incidence of arterial or venous thromboses proven by objective imaging (ultrasound, computerized tomography, magnetic resonance imaging, scintigraphy) and laboratory (troponin) methods.
- Incidence of major bleeding [At 30-days from hospital admission]
Incidence of bleeding events that can be classified by the International Society on Thrombosis and Haemostasis criteria as major bleeding.
- Incidence of bacteriemia [At 30-days from hospital admission]
Incidence of positive blood cultures that were taken based on clinical suspicion for bacterial co-infection.
- Incidence of mechanical ventilation [At 30-days from hospital admission]
Incidence of mechanical ventilation use required for deteriorating respiratory function.
- Incidence of intensive care unit admission [At 30-days from hospital admission]
Incidence of intensive care unit admission required for intensive/critical level of care.
Eligibility Criteria
Criteria
Inclusion Criteria:
- all hospitalized patients positive for COVID-19
Exclusion Criteria:
- none
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | University Hospital Dubrava | Zagreb | Grad Zagreb | Croatia | 10000 |
Sponsors and Collaborators
- University Hospital Dubrava
Investigators
- Study Director: Marko Lucijanic, MD PhD, University Hospital Dubrava
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2021/2503-04