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

NCT ID: NCT04659187

Last Updated: 2020-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

4000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-26

Study Completion Date

2021-07-01

Brief Summary

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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

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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.

Conditions

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COVID-19

Keywords

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COVID-19 Corona Risk factor SARS-CoV-2

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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All hospitalized COVID-19 patients

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

No interventions assigned to this group

Subgroup: Detailed cohort of 7 hospitals

Cohort of 7 hospitals with detailed data set

No interventions assigned to this group

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

No interventions assigned to this group

Subgroup with oncological patients

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

No interventions assigned to this group

Subgroup with critical ill COVID-19 patients

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

No interventions assigned to this group

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Asklepios Kliniken GmbH & Co. KGaA

UNKNOWN

Sponsor Role collaborator

Asklepios proresearch

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christoph U Herborn, Prof. MD

Role: PRINCIPAL_INVESTIGATOR

Asklepios Kliniken GmbH & Co. KGaA

Locations

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Asklepios Fachkliniken München-Gauting

Gauting, Bavaria, Germany

Site Status RECRUITING

Asklepios Klinik St. Georg

Hamburg, , Germany

Site Status RECRUITING

Asklepios Klinik Wandsbek

Hamburg, , Germany

Site Status RECRUITING

Asklepios Klinik Barmbek

Hamburg, , Germany

Site Status RECRUITING

Asklepios Kliniken GmbH & Co. KGaA

Hamburg, , Germany

Site Status RECRUITING

Asklepios Klinik Nord

Hamburg, , Germany

Site Status RECRUITING

Asklepios Westklinikum Hamburg

Hamburg, , Germany

Site Status RECRUITING

Asklepios Klinik Altona

Hamburg, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Nele Gessler, MD

Role: CONTACT

Phone: +49-401818 85 30 69

Email: [email protected]

Melanie Gunawardene, MD

Role: CONTACT

Phone: +40-401818855412

Email: [email protected]

Facility Contacts

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Nele Gessler, MD

Role: primary

References

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Dickow J, Gunawardene MA, Willems S, Feldhege J, Wohlmuth P, Bachmann M, Bergmann MW, Gesierich W, Nowak L, Pape UF, Schreiber R, Wirtz S, Twerenbold R, Sheikhzadeh S, Gessler N. Higher in-hospital mortality in SARS-CoV-2 omicron variant infection compared to influenza infection-Insights from the CORONA Germany study. PLoS One. 2023 Sep 27;18(9):e0292017. doi: 10.1371/journal.pone.0292017. eCollection 2023.

Reference Type DERIVED
PMID: 37756299 (View on PubMed)

Sievering AW, Wohlmuth P, Gessler N, Gunawardene MA, Herrlinger K, Bein B, Arnold D, Bergmann M, Nowak L, Gloeckner C, Koch I, Bachmann M, Herborn CU, Stang A. Comparison of machine learning methods with logistic regression analysis in creating predictive models for risk of critical in-hospital events in COVID-19 patients on hospital admission. BMC Med Inform Decis Mak. 2022 Nov 28;22(1):309. doi: 10.1186/s12911-022-02057-4.

Reference Type DERIVED
PMID: 36437469 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34138888 (View on PubMed)

Other Identifiers

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#3871

Identifier Type: -

Identifier Source: org_study_id