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

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

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.

Study Overview

• Status: Unknown
• Conditions: 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.

• Study Type: Observational
• Enrollment (Anticipated): 4000

Contacts and Locations

• Study Contact: Name: Nele Gessler, MD; Phone Number: +49-401818 85 30 69; Email: n.gessler@asklepios.com
• Study Contact Backup: Name: Melanie Gunawardene, MD; Phone Number: +40-401818855412; Email: m.gunawardene@asklepios.com

Study Locations

• Germany
  • Hamburg, Germany, 22763
    • Recruiting
    • Asklepios Klinik Altona
    • Principal Investigator: Dirk Arnold, Prof. MD
    • Principal Investigator: Hans-Peter Hauber, MD
  • Hamburg, Germany, 20099
    • Recruiting
    • Asklepios Klinik St. Georg
    • Principal Investigator: Ulrich-Frank Pape, MD
    • Principal Investigator: Bertholt Bein, Prof. MD
    • Principal Investigator: Stephan Willems, Prof. MD
  • Hamburg, Germany, 22291
    • Recruiting
    • Asklepios Klinik Barmbek
    • Principal Investigator: Axel Stang, Prof. MD
    • Principal Investigator: Sebastian Wirtz, MD
  • Hamburg, Germany, 22307
    • Recruiting
    • Asklepios Kliniken GmbH & Co. KGaA
    • Contact: Nele Gessler, MD
    • Principal Investigator: Christoph U Herborn, Prof. MD
    • Principal Investigator: Christian Glöckner, MD
  • Hamburg, Germany, 22043
    • Recruiting
    • Asklepios Klinik Wandsbek
    • Principal Investigator: Thomas Hölting, MD
    • Principal Investigator: Martin Bergmann, Prof. MD
  • Hamburg, Germany, 22417
    • Recruiting
    • Asklepios Klinik Nord
    • Principal Investigator: Klaus Herrlinger, Prof. MD
    • Principal Investigator: Tino Schnitgerhans, MD
  • Hamburg, Germany, 22559
    • Recruiting
    • Asklepios Westklinikum Hamburg
    • Principal Investigator: Rüdiger Schreiber, MD
  • Bavaria
    • Gauting, Bavaria, Germany, 82131
      • Recruiting
      • Asklepios Fachkliniken München-Gauting
      • Principal Investigator: Jürgen Behr, Prof. MD
      • Principal Investigator: Lorenz Nowak, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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)

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Asklepios proresearch
• Collaborators: Asklepios Kliniken GmbH & Co. KGaA
• Investigators: Principal Investigator: Christoph U Herborn, Prof. MD, Asklepios Kliniken GmbH & Co. KGaA

Publications and helpful links

General Publications

• Gessler N, Gunawardene MA, Wohlmuth P, Arnold D, Behr J, Gloeckner C, Herrlinger K, Hoelting T, Pape UF, Schreiber R, Stang A, Wesseler C, Willems S, Arms C, Herborn CU. Clinical outcome, risk assessment, and seasonal variation in hospitalized COVID-19 patients-Results from the CORONA Germany study. PLoS One. 2021 Jun 17;16(6):e0252867. doi: 10.1371/journal.pone.0252867. eCollection 2021.

Study record dates

Study Major Dates

• Study Start (Actual): March 26, 2020
• Primary Completion (Anticipated): May 30, 2021
• Study Completion (Anticipated): July 1, 2021

Study Registration Dates

• First Submitted: December 8, 2020
• First Submitted That Met QC Criteria: December 8, 2020
• First Posted (Actual): December 9, 2020

Study Record Updates

• Last Update Posted (Actual): December 17, 2020
• Last Update Submitted That Met QC Criteria: December 15, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: SARS-CoV-2; COVID-19; Corona; Risk factor
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: #3871

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual patient data will be collected anonymously. Sharing is not planned.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No