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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remdesivir exposure | Patients treated with remdesivir due to the COVID-19 infection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observation | Other | Observation of clinical outcomes and comparison to non-treated patients |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | Incidence of death from any cause | At 30-days from hospital admission |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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All patients that were hospitalized in our institution due to the COVID-19 infection
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| Name | Affiliation | Role |
|---|---|---|
| Marko Lucijanic, MD PhD | University Hospital Dubrava | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Dubrava | Zagreb | City of Zagreb | 10000 | Croatia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37529905 | Derived | Lucijanic M, Krecak I, Cicic D, Milosevic M, Vukoja D, Kovacevic I, Marasovic I, Sedinic Lacko M, Bakovic J, Jonjic Z, Vasilj T, Stojic J, Atic A. Hypoosmolar and hyperosmolar COVID-19 patients are predisposed to dismal clinical outcomes. Scand J Clin Lab Invest. 2023 Oct;83(6):397-402. doi: 10.1080/00365513.2023.2241368. Epub 2023 Aug 2. |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D013927 | Thrombosis |
| D006470 | Hemorrhage |
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D019370 | Observation |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
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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 |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |