Trial document




drksid header

  DRKS00023263

Trial Description

start of 1:1-Block title

Title

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

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

Trial Acronym

[---]*

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

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.

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

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.

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?

No

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

Description IPD sharing plan:

[---]*

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

Organizational Data

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

  •   Serological testing of antibodies against SARS-CoV-2 and an analysis of differences between symptomatic and asymptomatic COVID19 courses.
end of 1:N-Block indications
start of 1:N-Block interventions

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.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

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

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.

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

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.

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

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

Recruitment

  •   Planned
  •   2021/01/15
  •   4500
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   72   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

18 years and interest in blood donation.

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

Exclusion Criteria

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

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

Addresses

  • start of 1:1-Block address primary-sponsor
    • Institut für Medizinische Mikrobiologie und Krankenhaushygiene (IMMB)
    • Mr.  Prof. Dr. med.  Achim  Kaasch 
    • Leipziger Str. 44
    • 39120  Magdeburg
    • 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 other
    • Institut für Sozialmedizin und Gesundheitssystemforschung (ISMG)
    • Mr.  Prof. Dr.  Christian  Apfelbacher 
    • Leipziger Str. 44
    • 39120  Magdeburg
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    end of 1:1-Block address contact other
  • start of 1:1-Block address scientific-contact
    • Institut für Medizinische Mikrobiologie und Krankenhaushygiene (IMMB)
    • Mr.  Prof. Dr. med.  Heuft  Hans-Gert 
    • Leipziger Str. 44
    • 39120  Magdeburg
    • 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
    • Institut für Transfusionsmedizin und Immunhämatologie mit Blutbank
    • Mr.  Stephan  Krämer 
    • Leipziger Str. 44
    • 39120  Magdeburg
    • 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
    • Ministerium für Wissenschaft, Wirtschaft und Digitalisierung des Landes Sachsen-Anhalt
    • 39104  Magdeburg
    • 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 planned
  •   [---]*
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.