Trial document



drksid header

  DRKS00021225

Trial Description

start of 1:1-Block title

Title

COVID-19 Registry of the LMU Munich

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

CORKUM

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Patients infected by the new corona virus (COVID-19) exhibit a variable course of disease. The aim of this project is to characterize the clinical course of COVID-19 infections and identify biomarkers to predict morbidity and mortality of those patients.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Patients infected by the new corona virus (COVID-19) exhibit a variable course of disease. The aim of this project is to characterize the etiology and clinical course of COVID-19 infections and identify biomarkers to predict morbidity and mortality of those patients.

end of 1:1-Block scientific synopsis
start of 1:1-Block forwarded Data

Do you plan to share individual participant data with other researchers?

Yes

end of 1:1-Block forwarded Data
start of 1:1-Block forwarded Data Content

Description IPD sharing plan:

We can share the following data on request: age, gender, past medical history, vital signs, symptoms, recent travel, contact to infected persons, clinical course, intubation, ECLS therapy, medication, sonography, radiology and pathology reports.

end of 1:1-Block forwarded Data Content
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00021225
  •   2020/04/01
  •   [---]*
  •   yes
  •   Approved
  •   20-245, Ethik-Kommission der Medizinischen Fakultät der Ludwig-Maximilians-Universität München
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   J12.8 -  Other viral pneumonia
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Confirmed SARS-CoV-2 infection
  •   SARS-CoV-2 negative patients, which often showed symptoms of an infection but were tested negative
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Observational study
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Treatment
  •   Other
  •   N/A
  •   [---]*
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

The aim of this project is to characterize the etiology and clinical course of COVID-19 infections and identify biomarkers to predict morbidity and mortality of those patients.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

[---]*

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2020/04/02
  •   1500
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Confirmed SARS-CoV-2 infection OR SARS-CoV-2 negative patients, which often showed symptoms of an infection but were tested negative

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

Age < 18 years

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Klinikum der Universität München, Campus Großhadern
    • Marchioninistraße 15
    • 81377  München
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Medizinische Klinik III
    • Mr.  Dr. med.  Johannes  Hellmuth 
    • Marchioninistr. 15
    • 81377  Münchehn
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address scientific-contact
    • Max von Pettenkofer-Institut
    • Mr.  Dr. med.  Maximilian  Münchhoff 
    • Pettenkoferstr. 9a
    • 80336  München
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Medizinische Klinik III
    • Mr.  Dr. med.  Johannes  Hellmuth 
    • Marchioninistr. 15
    • 81377  Münchehn
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Klinikum der Universität München, Campus Großhadern
    • Marchioninistraße 15
    • 81377  München
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
  •   [---]*
  •   [---]*
  •   [---]*
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.