Serological investigations of blood donors from the city and area around Magdeburg for antibodies against SARS-CoV-2 (COVID-19)
Organizational Data
- DRKS-ID:
- DRKS00023263
- Recruitment Status:
- Recruiting ongoing
- Date of registration in DRKS:
- 2020-12-04
- Last update in DRKS:
- 2021-12-03
- Registration type:
- Prospective
Acronym/abbreviation of the study
No Entry
URL of the study
No Entry
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.
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.
Health condition or problem studied
- Free text:
- Serological testing of antibodies against SARS-CoV-2 and an analysis of differences between symptomatic and asymptomatic COVID19 courses.
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- 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).
- Arm 2:
- Testing of approximately 2,000 blood samples from whole blood donations prior to the outbreak of COVID-19 (2019), which are already available.
Endpoints
- 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. Measurement period: BP-0: approximately 2,000 available samples from 2019 period. BP-1: approx. 2,000 donors, period: January 21, 2021 to April 30, 2021 BP-2: approx. 2,000 donors, period: July 01 to October 31, 2021 BP-3: approx. 2,000 donors, period: January 24, 2022 to April 30, 2022 BP-4: approx. 2,000 donors, period: July 1, 2022 to October 31 2022 Measurement method: Serological examination by blood collection.
- Secondary outcome:
- To examine the influence of age, gender, occupational activities, home conditions, and frequency of family and other social contacts on the frequency of SARS-CoV2 antibodies. To analyze differences between participants* with symptomatic and asymptomatic COVID19 histories To survey vaccination readiness, vaccination attitudes, and the effect of a vaccination campaign on them, if applicable To analyze the impact of vaccines on antibody detection rates. The comparison of different antibody tests (test quality). Measurement methods: Questionnaires and blood samples.
Study Design
- Purpose:
- Screening
- Retrospective/prospective:
- No Entry
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- No Entry
- Study type non-interventional:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting ongoing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
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- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- University medical center Institut für Transfusionsmedizin und Immunhämatologie mit Blutbank Magdeburg
Recruitment period and number of participants
- Planned study start date:
- 2021-01-15
- Actual study start date:
- 2021-01-15
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 4500
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- 72 Years
- Additional Inclusion Criteria:
- 18 years and interest in blood donation.
Exclusion Criteria
The exclusion criteria are based on the German Medical Association’s donor exclusion criteria
Addresses
Primary Sponsor
- Address:
- Institut für Medizinische Mikrobiologie und Krankenhaushygiene (IMMB)Prof. Dr. med. Achim KaaschLeipziger Str. 4439120 MagdeburgGermany
- Telephone:
- 0391-67-13392
- Fax:
- 0391-67-13384
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.immb.ovgu.de/
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Institut für Medizinische Mikrobiologie und Krankenhaushygiene (IMMB)Prof. Dr. med. Heuft Hans-GertLeipziger Str. 4439120 MagdeburgGermany
- Telephone:
- 0391 / 67 - 13700
- Fax:
- 0391 / 67 - 13747
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.itib.ovgu.de/
Contact for Public Queries
- Address:
- Institut für Transfusionsmedizin und Immunhämatologie mit BlutbankStephan KrämerLeipziger Str. 4439120 MagdeburgGermany
- Telephone:
- 0391-67-13700
- Fax:
- 0391-67-13747
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.itib.ovgu.de/
Principal Investigator
- Address:
- Institut für Medizinische Mikrobiologie und Krankenhaushygiene (IMMB)Prof. Dr. med. Heuft Hans-GertLeipziger Str. 4439120 MagdeburgGermany
- Telephone:
- 0391 / 67 - 13700
- Fax:
- 0391 / 67 - 13747
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.itib.ovgu.de/
Sources of Monetary or Material Support
Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)
- Address:
- Ministerium für Wissenschaft, Wirtschaft und Digitalisierung des Landes Sachsen-Anhalt39104 MagdeburgGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethik-Kommission der Otto-von-Guericke-Universität an der Medizinischen Fakultät und am Universitätsklinikum Magdeburg A.ö.R.Leipziger Str. 44 Haus 2839120 MagdeburgGermany
- Telephone:
- +49-391-6714314
- Fax:
- +49-391-67290185
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2020-09-30
- Ethics committee number:
- 163/20
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2020-10-23
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry