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COVID-19CORONA GermanyNCT04659187

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

An observational study of COVID-19, run by Asklepios proresearch at 8 sites in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Any age
Conditions the study is for
COVID-19
How many people
4,000 participants
Where
8 sitesGermany
Study dates
26 Mar 2020to 1 Jul 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: all consecutive hospitalized patients tested positive for SARS CoV-2 using a reliable test method (mostly polymerase chain reaction test)

Who may be able to join

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

Who cannot join

  • Patients with negative SARS CoV-2 testing

Trial locations and contacts

8 sites in 1 country.

Nele Gessler, MD contact

+49-401818 85 30 69

n.gessler@asklepios.com

Melanie Gunawardene, MD contact

+40-401818855412

m.gunawardene@asklepios.com

8 sites in 1 country

Germany8 sites, 8 recruiting

  • Asklepios Fachkliniken München-Gauting

    Gauting, Bavaria, 82131

    Jürgen Behr, Prof. MD

    Lorenz Nowak, MD

    Recruiting

  • Asklepios Klinik St. Georg

    Hamburg, 20099

    Ulrich-Frank Pape, MD

    Bertholt Bein, Prof. MD

    Recruiting

  • Asklepios Klinik Wandsbek

    Hamburg, 22043

    Thomas Hölting, MD

    Martin Bergmann, Prof. MD

    Recruiting

  • Asklepios Klinik Barmbek

    Hamburg, 22291

    Axel Stang, Prof. MD

    Sebastian Wirtz, MD

    Recruiting

  • Asklepios Kliniken GmbH & Co. KGaA

    Hamburg, 22307

    Nele Gessler, MD

    Christoph U Herborn, Prof. MD

    Recruiting

  • Asklepios Klinik Nord

    Hamburg, 22417

    Klaus Herrlinger, Prof. MD

    Tino Schnitgerhans, MD

    Recruiting

  • Asklepios Westklinikum Hamburg

    Hamburg, 22559

    Rüdiger Schreiber, MD

    Recruiting

  • Asklepios Klinik Altona

    Hamburg, 22763

    Dirk Arnold, Prof. MD

    Hans-Peter Hauber, MD

    Recruiting

Other trials in Germany

About this study

Official title: "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.

Read the 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.

Conditions
COVID-19
Keywords
COVID-19, Corona, Risk factor, SARS-CoV-2
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04659187
Study groupRoleWhat they receive
All hospitalized COVID-19 patientsAll consecutive hospitalized patients, tested positive for SARS-CoV-2 at 45 Asklepios hospitals in Germany
Subgroup: Detailed cohort of 7 hospitalsCohort of 7 hospitals with detailed data set
Subgroup with cardiovascular eventsDefinition: 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 patientsDefinition: Patients hospitalized to COVID-19 with prior or preexisting oncological disease
Subgroup with critical ill COVID-19 patientsDefinition: Patients hospitalized to COVID-19 with intensive care treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 9 months

  2. 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

    Measured: 9 months

Secondary outcomes (2)

  1. 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

    Measured: 9 months

  2. 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

    Measured: 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2020
  2. Study start26 Mar 2020
  3. Primary completion30 May 2021 (estimated)
  4. Study completion1 Jul 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
4,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04659187
Sponsor's protocol ID
#3871
Acronym
CORONA Germany
Status last verified
Dec 2020
First submitted
8 Dec 2020
Last updated
17 Dec 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual patient data will be collected anonymously. Sharing is not planned.

Publications

  • 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.

    PubMed 37756299

  • 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.

    PubMed 36437469

  • 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.

    PubMed 34138888

Questions about this trial

What is this clinical trial studying?

An observational study of COVID-19, run by Asklepios proresearch at 8 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Nele Gessler, MD (+49-401818 85 30 69, n.gessler@asklepios.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite of death and/or need for mechanical ventilation and/or admission to ICU (time frame: 9 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04659187, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2020.

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