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| Name | Class |
|---|---|
| Asklepios Kliniken GmbH & Co. KGaA | UNKNOWN |
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This is a multicenter, observational, prospective, epidemiological cohort study at 45 hospitals in Germany, all part of a German hospital network. All hospitalized patients tested positive for SARS-CoV-2 will be included.
CORONA Germany is a multicenter, observational, prospective, epidemiological cohort study at 45 hospitals in Germany, all part of a German hospital network. From January 1st till November 17th, 2020, all hospitalized patients tested positive for SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) will be included. Demographical data and outcomes will be assessed in the entire study cohort. In a subgroup, consisting of 7 hospitals, further detailed data (e.g. baseline characteristics, laboratory values, medication, clinical events) will be assessed. Additionally, there will be subgroups of patients with cardiovascular events and prior or preexisting oncological diseases. There are two primary endpoints: 1. Combination of all-cause death and/or need for mechanical ventilation and/or allocation to intensive care unit (ICU). 2. Occurrence of a clinical manifest cardiovascular events. The aim of the study is the development of a prediction model for the primary endpoints, whereas the secondary endpoint is a comparison of mortality rates between the 1st (01/01/20-09/15/20) and 2nd (15/09/20) infection wave. All endpoints will be verified by an Endpoint Review Committee. A Steering Committee, consisting of representatives of the 45 hospitals, the trial statistician and members of the scientific department, takes responsibility of the study design and results.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All hospitalized COVID-19 patients | All consecutive hospitalized patients, tested positive for SARS-CoV-2 at 45 Asklepios hospitals in Germany | ||
| Subgroup: Detailed cohort of 7 hospitals | Cohort of 7 hospitals with detailed data set | ||
| Subgroup with cardiovascular events | Definition: Patients hospitalized to COVID-19, who developed a cardiovascular event, defined as (1) cardiopulmonary resuscitation in cardiac arrest, (2) cardiogenic shock, (3) acute coronary artery syndrome, including ST-segment elevation myocardial infarction (STEMI) and non-ST-segment elevation myocardial infarction (NSTEMI), (4) acute myocarditis, (5) denovo cardiac arrhythmia, (6) arterial or venous thrombosis, (7) pulmonary artery embolism, (8) worsening of prior or new onset heart failure, (9) ischemic stroke | ||
| Subgroup with oncological patients | Definition: Patients hospitalized to COVID-19 with prior or preexisting oncological disease | ||
| Subgroup with critical ill COVID-19 patients | Definition: Patients hospitalized to COVID-19 with intensive care treatment |
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| Measure | Description | Time Frame |
|---|---|---|
| Composite of death and/or need for mechanical ventilation and/or admission to ICU | Composite of death and/or need for mechanical ventilation and/or admission to ICU in patients hospitalized to COVID 19 | 9 months |
| Occurrence of a clinical manifest cardiovascular event | Occurrence of a clinical manifest cardiovascular Event, defined as (1) cardiopulmonary resuscitation in cardiac arrest, (2) cardiogenic shock, (3) acute coronary artery syndrome, including ST-segment elevation myocardial infarction (STEMI) and non-ST-segment elevation myocardial infarction (NSTEMI), (4) acute myocarditis, (5) denovo cardiac arrhythmia, (6) arterial or venous thrombosis, (7) pulmonary artery embolism, (8) worsening of prior or new onset heart failure, (9) ischemic stroke | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall mortality and mortality rate | Comparison of mortality rates between the 1st (01/01/20-09/15/20) and 2nd (15/09/20) infection wave | 9 months |
| Risk stratification score to predict the primary endpoints |
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Inclusion Criteria:
Exclusion Criteria:
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all consecutive hospitalized patients tested positive for SARS CoV-2 using a reliable test method (mostly polymerase chain reaction test)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nele Gessler, MD | Contact | +49-401818 85 30 69 | n.gessler@asklepios.com | |
| Melanie Gunawardene, MD | Contact | +40-401818855412 | m.gunawardene@asklepios.com |
| Name | Affiliation | Role |
|---|---|---|
| Christoph U Herborn, Prof. MD | Asklepios Kliniken GmbH & Co. KGaA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asklepios Fachkliniken München-Gauting | Recruiting | Gauting | Bavaria | 82131 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37756299 | Derived | Dickow J, Gunawardene MA, Willems S, Feldhege J, Wohlmuth P, Bachmann M, Bergmann MW, Gesierich W, Nowak L, Pape UF, Schreiber R, Wirtz S, Twerenbold R, Sheikhzadeh S, Gessler N. Higher in-hospital mortality in SARS-CoV-2 omicron variant infection compared to influenza infection-Insights from the CORONA Germany study. PLoS One. 2023 Sep 27;18(9):e0292017. doi: 10.1371/journal.pone.0292017. eCollection 2023. | |
| 36437469 |
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Individual patient data will be collected anonymously. Sharing is not planned.
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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Risk stratification score to predict the primary endpoint in hospitalized COVID 19 patients in the subgroup of seven hospitals
| 9 months |
| Asklepios Klinik St. Georg | Recruiting | Hamburg | 20099 | Germany |
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| Asklepios Klinik Wandsbek | Recruiting | Hamburg | 22043 | Germany |
|
| Asklepios Klinik Barmbek | Recruiting | Hamburg | 22291 | Germany |
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| Asklepios Kliniken GmbH & Co. KGaA | Recruiting | Hamburg | 22307 | Germany |
|
| Asklepios Klinik Nord | Recruiting | Hamburg | 22417 | Germany |
|
| Asklepios Westklinikum Hamburg | Recruiting | Hamburg | 22559 | Germany |
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| Asklepios Klinik Altona | Recruiting | Hamburg | 22763 | Germany |
|
| Derived |
| Sievering AW, Wohlmuth P, Gessler N, Gunawardene MA, Herrlinger K, Bein B, Arnold D, Bergmann M, Nowak L, Gloeckner C, Koch I, Bachmann M, Herborn CU, Stang A. Comparison of machine learning methods with logistic regression analysis in creating predictive models for risk of critical in-hospital events in COVID-19 patients on hospital admission. BMC Med Inform Decis Mak. 2022 Nov 28;22(1):309. doi: 10.1186/s12911-022-02057-4. |
| 34138888 | Derived | Gessler N, Gunawardene MA, Wohlmuth P, Arnold D, Behr J, Gloeckner C, Herrlinger K, Hoelting T, Pape UF, Schreiber R, Stang A, Wesseler C, Willems S, Arms C, Herborn CU. Clinical outcome, risk assessment, and seasonal variation in hospitalized COVID-19 patients-Results from the CORONA Germany study. PLoS One. 2021 Jun 17;16(6):e0252867. doi: 10.1371/journal.pone.0252867. eCollection 2021. |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |