Trial document





This trial has been registered retrospectively.
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  DRKS00023364

Trial Description

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Title

Seroprevalence of SARS CoV-2 infections/Covid-19 in blood donors and patients of the University Hospitals in Leipzig

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

The study examines the percentage of individuals with previous SARS CoV-2 infection in Leipzig. It studies four different populations:
1. All patients of the University hospitals that require blood testing for medical reasons
2. Blood donors
3. Patients with chronic neurologic disease
4. Patients with advanced liver disease
Leftovers of serum and plasma samples obtained for medical purposes will be sampled and tested for antibodies against the SARS CoV-2 at several time points over 12 months. The percentage of seropositive individuals in each group and at different time points will be determined and compared.

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Brief Summary in Scientific Language

The study examines the percentage of individuals with previous SARS CoV-2 infection in Leipzig. It studies four different populations:
1. All patients of the University hospitals that require blood testing for medical reasons
2. Blood donors
3. Patients with chronic neurologic disease
4. Patients with advanced liver disease
Leftovers of serum and plasma samples obtained for medical purposes will be sampled and tested for antibodies against the SARS CoV-2 at several time points over 12 months. The percentage of seropositive individuals in each group and at different time points will be determined and compared.

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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

  •   DRKS00023364
  •   2020/10/19
  •   [---]*
  •   yes
  •   Approved
  •   147/20-ek, Ethikkommission an der Medizinischen Fakultät der Universität Leipzig
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

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

  •   No intervention. Examination of the SARS CoV-2-specific antibody response in left-over serum and blood samples
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Characteristics

  •   Non-interventional
  •   Epidemiological study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

IgG antibody response to SARS CoV-2 will be tested using an antibody test (e. g. ELISA)

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Secondary Outcome

No other measurements

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2020/06/20
  •   2000
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Four groups of individuals:
1. All patients at the University Hospital from which blood has been taken for medical reasons
2. Blood donors
3. Patients from the neurologic walk-in clinic
4. Patients with advanced liver disease

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Exclusion Criteria

Serum and plasma samples that are not suitable for technical reasons

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Addresses

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    • Institut für Medizinische Mikrobiologie und Virologie, Universitätsklinikum Leipzig
    • Mr.  Prof. Dr.  Christian  Jassoy 
    • Johannisallee 30
    • 04103  Leipzig
    • Germany
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    • Institut für Transfusionsmedizin, Universitätsklinikum Leipzig
    • Mr.  Prof. Dr.  Reinhard  Henschler 
    • Johannisallee 32
    • 04103  Leipzig
    • Germany
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    • Institut für Laboratoriumsmedizin, Klinische Chemie und Molekulare Diagnostik, Universitätsklinikum Leipzig
    • Mr.  Dr.  Thorsten  Kaiser 
    • Paul-List-Str. 13/15
    • 04103  Leipzig
    • Germany
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    • Klinik und Poliklinik fuer Neurologie, Universitätsklinikum Leipzig
    • Mr.  Prof. Dr.  Florian  Then Bergh 
    • Liebigstraße 20
    • 04103  Leipzig
    • Germany
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    • Institut für Medizinische Mikrobiologie und Virologie, Universitätsklinikum Leipzig
    • Mr.  Prof. Dr.  Christian  Jassoy 
    • Johannisallee 30
    • 04103  Leipzig
    • Germany
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    • Institut für Medizinische Mikrobiologie und Virologie, Universitätsklinikum Leipzig
    • Mr.  Prof. Dr.  Christian  Jassoy 
    • Johannisallee 30
    • 04103  Leipzig
    • Germany
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Sources of Monetary or Material Support

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    • Institut für Medizinische Mikrobiologie und Virologie, Universitätsklinikum Leipzig
    • Mr.  Prof. Dr.  Christian  Jassoy 
    • Johannisallee 30
    • 04103  Leipzig
    • Germany
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Status

  •   Recruiting suspended on temporary hold
  •   [---]*
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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.