Trial document




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  DRKS00021605

Trial Description

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Title

COVID-19 in an academic teaching hospital in Konstanz/Germany - evaluation of the "double rule out - single rule in" concept (DURO-SIN)

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Trial Acronym

DURO-SIN

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URL of the Trial

http://www.studienzentrum-bodensee.de

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Brief Summary in Lay Language

The new corona-virus disease (COVID-19) may induce a rapid progressive pulmonary disease with potential intensive care treatment and mechanical ventilation. This study aims at early detecting potentially severe courses of COVID-19 by a combination of virus-detecting procedures (i.e. nasal swabs) and radiological examinations (i.e. computed tomography, CT) according to (inter-)national recommendations.
Only data of routine examinations will be included in this study.

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Brief Summary in Scientific Language

The new corona-virus disease (COVID-19) may induce a rapid progressive pulmonary disease with potential intensive care treatment and mechanical ventilation. This study aims at early detecting potentially severe courses of COVID-19 by a combination of naso-pharyngeal swabs detecting SARS-CoV-2 RNA and - according to disease severity - radiological examinations (i.e. computed tomography, CT) according to (inter-)national recommendations. Patients with severe hypoxic respiratory failure may be diagnosed with thoracic CT earlier.

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

No

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00021605
  •   2020/04/28
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  •   yes
  •   Approved
  •   81/2020, Ethik-Kommission der Universität Witten/Herdecke
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Secondary IDs

  •   U1111-1251-0310 
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Health Condition or Problem studied

  •   U07.1 -  Emergency use of U07.1
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Interventions/Observational Groups

  •   Radiological features of COVID-19 in the thoracic CT following a negative PCR test result regarding SARS-CoV-2 in clinically highly suspected cases
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Screening
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Descriptive evaluation of the DURO-SIN concept regarding SARS-CoV-2 detection in naso-pharyngeal swabs and positive radiological features

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Secondary Outcome

Clinical course of positively screened patients (RNA, CT) regarding disease severity (evaluated with regard to respiratory support), treatment duration and treatment course.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2020/04/27
  •   200
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Suspected COVID-19

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Exclusion Criteria

Missing clinical or radiological features of COVID-19
Pregnancy

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Klinikum Konstanz II. Medizin
    • Mr.  Dr. med.  Stephan  Walterspacher 
    • Mainaustr. 35
    • 78464  Konstanz
    • Germany
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    • Klinikum Konstanz II. Medizin
    • Mr.  Dr. med.  Stephan  Walterspacher 
    • Mainaustr. 35
    • 78464  Konstanz
    • Germany
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    end of 1:1-Block address contact scientific-contact
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    • Klinikum Konstanz II. Medizin
    • Mr.  Dr. med.  Stephan  Walterspacher 
    • Mainaustr. 35
    • 78464  Konstanz
    • Germany
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Sources of Monetary or Material Support

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    • Klinikum Konstanz II. Medizin
    • Mr.  Dr. med.  Stephan  Walterspacher 
    • Mainaustr. 35
    • 78464  Konstanz
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.