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

COVID-19 Clinical Trial

— CORONA Germany  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04659187
• Other study ID #: #3871
• Status: Recruiting
• Start date: March 26, 2020
• Est. completion date: July 1, 2021

Study information

• Verified date: December 2020
• Source: Asklepios proresearch
• Contact: Nele Gessler, MD
• Phone: +49-401818 85 30 69
• Email: n.gessler[@]asklepios.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4000
• Est. completion date: July 1, 2021
• Est. primary completion date: May 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Locations

Country	Name	City	State
Germany	Asklepios Fachkliniken München-Gauting	Gauting	Bavaria
Germany	Asklepios Klinik Altona	Hamburg
Germany	Asklepios Klinik Barmbek	Hamburg
Germany	Asklepios Klinik Nord	Hamburg
Germany	Asklepios Klinik St. Georg	Hamburg
Germany	Asklepios Klinik Wandsbek	Hamburg
Germany	Asklepios Kliniken GmbH & Co. KGaA	Hamburg
Germany	Asklepios Westklinikum Hamburg	Hamburg

Sponsors (2)

Lead Sponsor	Collaborator
Asklepios proresearch	Asklepios Kliniken GmbH & Co. KGaA

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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