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

Asklepios proresearch

Status: Unknown

Conditions: COVID-19

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT04659187

#3871

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

4,000 participants in 5 patient groups

All hospitalized COVID-19 patients

Description:

All consecutive hospitalized patients, tested positive for SARS-CoV-2 at 45 Asklepios hospitals in Germany

Subgroup: Detailed cohort of 7 hospitals

Description:

Cohort of 7 hospitals with detailed data set

Subgroup with cardiovascular events

Description:

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

Description:

Definition: Patients hospitalized to COVID-19 with prior or preexisting oncological disease

Subgroup with critical ill COVID-19 patients

Description:

Definition: Patients hospitalized to COVID-19 with intensive care treatment