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

NCT04659187 | Unknown DMC

• 1 other identifier: #3871
• Study Type: observational
• Target: 4,000
• Locations: 1 country
• Sites: 8

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.

Conditions

COVID-19

Keywords

COVID-19; Corona; Risk factor; SARS-CoV-2

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Overall mortality and mortality rate

  9 months

• Risk stratification score to predict the primary endpoints

  9 months

Study Arms (5)

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• hospitalized patients tested positive for SARS CoV-2 using a reliable test method (mostly polymerase chain reaction test)

You may not qualify if:

• Patients with negative SARS CoV-2 testing

Sponsors & Collaborators

• Asklepios proresearch: lead
• Asklepios Kliniken GmbH & Co. KGaA: collaborator

Study Sites (8)

Asklepios Fachkliniken München-Gauting

Gauting, Bavaria, 82131, Germany

RECRUITING

Asklepios Klinik St. Georg

Hamburg, 20099, Germany

RECRUITING

Asklepios Klinik Wandsbek

Hamburg, 22043, Germany

RECRUITING

Asklepios Klinik Barmbek

Hamburg, 22291, Germany

RECRUITING

Asklepios Kliniken GmbH & Co. KGaA

Hamburg, 22307, Germany

RECRUITING

Asklepios Klinik Nord

Hamburg, 22417, Germany

RECRUITING

Asklepios Westklinikum Hamburg

Hamburg, 22559, Germany

RECRUITING

Asklepios Klinik Altona

Hamburg, 22763, Germany

RECRUITING

Related Publications (3)

• 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.

  PMID: 37756299 DERIVED

• 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.

  PMID: 36437469 DERIVED

• 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.

  PMID: 34138888 DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Christoph U Herborn, Prof. MD

  Asklepios Kliniken GmbH & Co. KGaA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nele Gessler, MD

CONTACT

+49-401818 85 30 69; n.gessler@asklepios.com

Melanie Gunawardene, MD

CONTACT

+40-401818855412; m.gunawardene@asklepios.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2020
• First Posted: December 9, 2020
• Study Start: March 26, 2020
• Primary Completion: May 30, 2021
• Study Completion: July 1, 2021
• Last Updated: December 17, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (8)