CORONA Germany- Clinical Outcome and Risk in Hospitalized COVID-19 Patients - An Epidemiological Study From Germany

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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CORONA Germany - Clinical Outcome and Risk in Hospitalized COVID-19 Patients - An Epidemiological Study From Germany

Conditions
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COVID-19

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: hospitalized patients tested positive for SARS CoV-2 using a reliable test method (mostly polymerase chain reaction test) Exclusion Criteria: Patients with negative SARS CoV-2 testing
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All hospitalized COVID-19 patients<br>All consecutive hospitalized patients, tested positive for SARS-CoV-2 at 45 Asklepios hospitals in Germany | |
| Subgroup: Detailed cohort of 7 hospitals<br>Cohort of 7 hospitals with detailed data set | |
| Subgroup with cardiovascular events<br>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<br>Definition: Patients hospitalized to COVID-19 with prior or preexisting oncological disease | |
| Subgroup with critical ill COVID-19 patients<br>Definition: Patients hospitalized to COVID-19 with intensive care treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | Risk stratification score to predict the primary endpoint in hospitalized COVID 19 patients in the subgroup of seven hospitals | 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, Corona, Risk factor, SARS-CoV-2