COVID-19
Conditions
Keywords
COVID-19, Corona, Risk factor, SARS-CoV-2
Brief summary
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
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.
Interventions
None listed
Sponsors
Asklepios Kliniken GmbH & Co. KGaA
Asklepios proresearch
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite of death and/or need for mechanical ventilation and/or admission to ICU | 9 months | Composite of death and/or need for mechanical ventilation and/or admission to ICU in patients hospitalized to COVID 19 |
| Occurrence of a clinical manifest cardiovascular event | 9 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall mortality and mortality rate | 9 months | Comparison of mortality rates between the 1st (01/01/20-09/15/20) and 2nd (15/09/20) infection wave |
| Risk stratification score to predict the primary endpoints | 9 months | Risk stratification score to predict the primary endpoint in hospitalized COVID 19 patients in the subgroup of seven hospitals |
Countries
Germany
Contacts
Primary ContactNele Gessler, MD
Backup ContactMelanie Gunawardene, MD
Outcome results
None listed