Trial document




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  DRKS00023822

Trial Description

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Title

Validation of a SARS-CoV-2 (COVID-19) rapid antigen test in the daily routine of general practitioners for the diagnosis of corona infection

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

The aim of this study is to determine the accuracy of a rapid SARS-CoV-2 test in comparison to laboratory tests (PCR), which have been considered the gold standard. The rapid test is already approved in Germany, but so far it has not been tested in the clinical routine. We would like to find out how well the test is suited for the rapid detection or exclusion of a corona infection in the daily routine of a general practitioner.

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Brief Summary in Scientific Language

The diagnostic quality of a new rapid test for an suspected Covid-19 Infection should be evaluated for use the use in general practice. Above all, the sensitivity, but also the specificity of the test should be high. Additional criteria are the positive and negative predictive value. In order to be clinically convincing, the determined sensitivity and specificity should also apply with a high degree of certainty in practice, i.e. show a high degree of precision, which is expressed in a small confidence interval.
The study compares the SARS-CoV-2 rapid antigen test with the RT-PCR test (Gold Standard).
It is unclear whether the sensitivity and specificity declared by the manufacturer can also be reproduced in everyday clinical practice.
A further aim of the study is to investigate the correlation between test accuracy and symptoms in order to be able to estimate the significance of the test in patients with mild or unspecific symptoms.

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

Yes

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Description IPD sharing plan:

after request to the principal investigator

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Organizational Data

  •   DRKS00023822
  •   2020/12/21
  •   [---]*
  •   yes
  •   Approved
  •   254/20, Ethik-Kommission der Medizinischen Fakultät der Universität Würzburg
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Secondary IDs

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Health Condition or Problem studied

  •   U07.1 -  Emergency use of U07.1
  •   COVID-19
  •   SARS-CoV-19 infection
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Interventions/Observational Groups

  •   Nearly simultaneous testing for SARS-CoV-2 by PCR Test and rapid antigen Test.
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Characteristics

  •   Interventional
  •   [---]*
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   III
  •   N/A
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Primary Outcome

-Validation of sensitivity, specificity, positive predictive value, negative predictive value of a rapid SARS-CoV-2 antigen tests in daily clinical routine

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Secondary Outcome

[---]*

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2020/12/16
  •   4600
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

- respiratory symptoms (e.g. acute bronchitis or pneumonia, respiratory distress or fever)
- Acute hypo- or anosmia or hypo- or ageusia

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Exclusion Criteria

symptomatic and asymptomatic patients in a nursing home, asymptomatic patients whose testing is done for follow-up reasons (travel history, contact person, etc.)

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Addresses

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    • Universitätsklinikum Würzburg Institut für Allgemeinmedizin
    • Josef-Schneider-Straße 2/D7
    • 97080  Würzburg
    • Germany
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    • Universitätsklinikum WürzburgInstitut für Allgemeinmedizin
    • Mr.  Jörn  Rohde 
    • Josef-Schneider-Straße 2/D7
    • 97080  Würzburg
    • Germany
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    • Universitätsklinikum Würzburg Institut für Allgemeinmedizin
    • Mr.  Jörn  Rohde 
    • Josef-Schneider-Straße 2/D7
    • 97080  Würzburg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Würzburg Institut für Allgemeinmedizin
    • Josef-Schneider-Straße 2/D7
    • 97080  Würzburg
    • 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.