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

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ClinicalTrials.gov Identifier: NCT04659187
Recruitment Status : Recruiting
First Posted : December 9, 2020
Last Update Posted : December 17, 2020
Sponsor:
Collaborator:
Asklepios Kliniken GmbH & Co. KGaA
Information provided by (Responsible Party):
Asklepios proresearch

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.

Condition or disease
COVID-19

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.

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Study Type : Observational
Estimated Enrollment : 4000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: "CORONA Germany" - Clinical Outcome and Risk in Hospitalized COVID-19 Patients - An Epidemiological Study From Germany
Actual Study Start Date : March 26, 2020
Estimated Primary Completion Date : May 30, 2021
Estimated Study Completion Date : July 1, 2021

Group/Cohort
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



Primary Outcome Measures :
  1. Composite of death and/or need for mechanical ventilation and/or admission to ICU [ Time Frame: 9 months ]
    Composite of death and/or need for mechanical ventilation and/or admission to ICU in patients hospitalized to COVID 19

  2. Occurrence of a clinical manifest cardiovascular event [ Time Frame: 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 Outcome Measures :
  1. Overall mortality and mortality rate [ Time Frame: 9 months ]
    Comparison of mortality rates between the 1st (01/01/20-09/15/20) and 2nd (15/09/20) infection wave

  2. Risk stratification score to predict the primary endpoints [ Time Frame: 9 months ]
    Risk stratification score to predict the primary endpoint in hospitalized COVID 19 patients in the subgroup of seven hospitals



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
all consecutive hospitalized patients tested positive for SARS CoV-2 using a reliable test method (mostly polymerase chain reaction test)
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04659187


Contacts
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Contact: Nele Gessler, MD +49-401818 85 30 69 n.gessler@asklepios.com
Contact: Melanie Gunawardene, MD +40-401818855412 m.gunawardene@asklepios.com

Locations
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Germany
Asklepios Fachkliniken München-Gauting Recruiting
Gauting, Bavaria, Germany, 82131
Principal Investigator: Jürgen Behr, Prof. MD         
Principal Investigator: Lorenz Nowak, MD         
Asklepios Klinik St. Georg Recruiting
Hamburg, Germany, 20099
Principal Investigator: Ulrich-Frank Pape, MD         
Principal Investigator: Bertholt Bein, Prof. MD         
Principal Investigator: Stephan Willems, Prof. MD         
Asklepios Klinik Wandsbek Recruiting
Hamburg, Germany, 22043
Principal Investigator: Thomas Hölting, MD         
Principal Investigator: Martin Bergmann, Prof. MD         
Asklepios Klinik Barmbek Recruiting
Hamburg, Germany, 22291
Principal Investigator: Axel Stang, Prof. MD         
Principal Investigator: Sebastian Wirtz, MD         
Asklepios Kliniken GmbH & Co. KGaA Recruiting
Hamburg, Germany, 22307
Contact: Nele Gessler, MD         
Principal Investigator: Christoph U Herborn, Prof. MD         
Principal Investigator: Christian Glöckner, MD         
Asklepios Klinik Nord Recruiting
Hamburg, Germany, 22417
Principal Investigator: Klaus Herrlinger, Prof. MD         
Principal Investigator: Tino Schnitgerhans, MD         
Asklepios Westklinikum Hamburg Recruiting
Hamburg, Germany, 22559
Principal Investigator: Rüdiger Schreiber, MD         
Asklepios Klinik Altona Recruiting
Hamburg, Germany, 22763
Principal Investigator: Dirk Arnold, Prof. MD         
Principal Investigator: Hans-Peter Hauber, MD         
Sponsors and Collaborators
Asklepios proresearch
Asklepios Kliniken GmbH & Co. KGaA
Investigators
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Principal Investigator: Christoph U Herborn, Prof. MD Asklepios Kliniken GmbH & Co. KGaA
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Asklepios proresearch
ClinicalTrials.gov Identifier: NCT04659187    
Other Study ID Numbers: #3871
First Posted: December 9, 2020    Key Record Dates
Last Update Posted: December 17, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual patient data will be collected anonymously. Sharing is not planned.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Asklepios proresearch:
COVID-19
Corona
Risk factor
SARS-CoV-2
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases