Trial document



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  DRKS00023263

Trial Description

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Title

Serological investigations of blood donors from the city and area around Magdeburg for antibodies against SARS-CoV-2 (COVID-19)

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The SeMaCo study aims at a better estimation of the distribution and course of the coronavirus SARS-CoV-2 in Magdeburg and its surroundings. Blood donors of the University Blood Bank of the Medical Faculty of the Otto-von-Guericke University Magdeburg will be tested for antibodies in a period of 21 months at a total of 4 appointments.
In order to get an accurate picture of the course of a SARS-CoV-2 infection and to be able to make statements about a possible vaccination readiness against SARS-CoV-2, the participants will fill in 2 questionnaires at each of the 4 appointments. These questionnaires refer to contacts at work and in the family as well as to a vaccination readiness against the SARS-CoV-2 virus.

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Brief Summary in Scientific Language

SeMaCo is a prospective longitudinal, regional cohort study to determine the COVID-19 seroprevalence in blood donors from Magdeburg and surrounding areas as a surrogate of the healthy, able-bodied normal population in northern Saxony-Anhalt.
In erythrocyte, plasma or platelet donors, the frequency of antibodies against SARS-CoV-2 is to be determined at 4 points in time over a period of 21 months. The possibility to repeat testing of the same donors over this period will provide data on the persistence of the antibodies at least over the period of testing. In addition, the influence of age, gender, occupational activities, domestic conditions and the frequency of family and other social contacts on the incidence of SARS-CoV2-AK will be investigated. Furthermore, the study will allow an analysis of differences between symptomatic and asymptomatic COVID19 courses.
If a COVID-19 vaccine becomes available during the study period, the vaccination readiness and evaluation of a vaccination campaign in the volunteers will be recorded in addition to the serological examination, as well as an investigation of the influence of the vaccination on the detection rate of antibodies. A comparison of different antibody tests (test quality) will also be performed, especially when tests are updated.

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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

  •   DRKS00023263
  •   2020/12/04
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  •   yes
  •   Approved
  •   163/20, Ethikkommission der Medizinischen Fakultät der Otto-von-Guericke-Universität Magdeburg
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Secondary IDs

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Health Condition or Problem studied

  •   Serological testing of antibodies against SARS-CoV-2 and an analysis of differences between symptomatic and asymptomatic COVID19 courses.
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Interventions/Observational Groups

  •   Collection and testing of blood samples from whole blood donations from up to four specific points in time (blood sample-1: approximately 2,000 blood samples from 2,000 whole blood donations, Jan - March 2021; blood sample-2: approximately 2,000 blood samples from 2. 000 whole blood donations, July/August 2021; blood sample-3: approximately 2,000 blood samples from 2,000 whole blood donations, Dec 2021 - Feb 2022; blood sample-4: approximately 2,000 blood samples from 2,000 whole blood donations, June/July 2022 (if possible, blood samples are obtained from the same donors).
  •   Testing of approximately 2,000 blood samples from whole blood donations prior to the outbreak of COVID-19 (2019), which are already available.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Historical
  •   Screening
  •   Other
  •   IV
  •   N/A
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Primary Outcome

The frequency of IgG antibodies against SARS-CoV-2 in blood donors will be determined by serological analysis of blood samples over a period of approximately 18 - 21 months and the development over this period will be monitored.

Measuring period:
BS-0: approx. 2,000 samples from 2019
BS-1: approx. 2,000 donors, period, Jan - March 2021
BS-2: approx. 2,000 donors, period, July / August 2021
BS-3: approx. 2,000 donors, period Dec 2021 - Feb 2022
BS-4: Approximately 2,000 donors, period, June/July 2022.

Measurement method: Serological examination by blood collection.

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Secondary Outcome

To study the influence of age, gender, occupational activities, domestic conditions and the frequency of family and other social contacts on the incidence of SARS CoV2 antibodies.
The analysis of differences between participants with symptomatic and asymptomatic COVID19 courses.
The survey of vaccination readiness and, if necessary, the effect of a vaccination campaign on it (if a COVID-19 vaccine will be available during the study period).
With available vaccine, analysis of the influence of the vaccination on the detection rate of antibodies.
The comparison of different antibody tests (test quality).
Measurement method: Questionnaires and blood samples.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2021/01/15
  •   4500
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   72   Years
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Additional Inclusion Criteria

18 years and interest in blood donation.

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Exclusion Criteria

The exclusion criteria are based on the German Medical Association’s donor exclusion criteria

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Addresses

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    • Institut für Medizinische Mikrobiologie und Krankenhaushygiene (IMMB)
    • Mr.  Prof. Dr. med.  Achim  Kaasch 
    • Leipziger Str. 44
    • 39120  Magdeburg
    • Germany
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    • Institut für Sozialmedizin und Gesundheitssystemforschung (ISMG)
    • Mr.  Prof. Dr.  Christian  Apfelbacher 
    • Leipziger Str. 44
    • 39120  Magdeburg
    • Germany
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    • Institut für Medizinische Mikrobiologie und Krankenhaushygiene (IMMB)
    • Mr.  Prof. Dr. med.  Heuft  Hans-Gert 
    • Leipziger Str. 44
    • 39120  Magdeburg
    • Germany
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    • Institut für Transfusionsmedizin und Immunhämatologie mit Blutbank
    • Mr.  Stephan  Krämer 
    • Leipziger Str. 44
    • 39120  Magdeburg
    • Germany
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Sources of Monetary or Material Support

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    • Ministerium für Wissenschaft, Wirtschaft und Digitalisierung des Landes Sachsen-Anhalt
    • 39104  Magdeburg
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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