Clinical trial NCT04659187: CORONA Germany- Clinical Outcome and Risk in Hospitalized COVID-19 Patients - An Epidemiological Study From Germany
Official title: "CORONA Germany" - Clinical Outcome and Risk in Hospitalized COVID-19 Patients - An Epidemiological Study From Germany
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Keywords: COVID-19
Corona
Risk factor
SARS-CoV-2
Lead sponsor: Asklepios proresearch
Sponsor class: INDUSTRY
Collaborators: name: Asklepios Kliniken GmbH & Co. KGaA
First posted: 2020-12-09
Enrollment: 4000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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)

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.

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.

Eligibility 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

Primary outcomes:
measure: Composite of death and/or need for mechanical ventilation and/or admission to ICU
timeFrame: 9 months
measure: Occurrence of a clinical manifest cardiovascular event
timeFrame: 9 months
Secondary outcomes:
measure: Overall mortality and mortality rate
timeFrame: 9 months
measure: Risk stratification score to predict the primary endpoints
timeFrame: 9 months
Other outcomes:
Locations:
city: Gauting
country: Germany
facility: Asklepios Fachkliniken München-Gauting
state: Bavaria
city: Hamburg
country: Germany
facility: Asklepios Klinik St. Georg
city: Hamburg
country: Germany
facility: Asklepios Klinik Wandsbek
city: Hamburg
country: Germany
facility: Asklepios Klinik Barmbek
city: Hamburg
country: Germany
facility: Asklepios Kliniken GmbH & Co. KGaA
city: Hamburg
country: Germany
facility: Asklepios Klinik Nord
city: Hamburg
country: Germany
facility: Asklepios Westklinikum Hamburg
city: Hamburg
country: Germany
facility: Asklepios Klinik Altona
Study officials:
affiliation: Asklepios Kliniken GmbH & Co. KGaA
name: Christoph U Herborn, Prof. MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.