Screening for COVID-19 and Monitoring of Serological Responses to SARS-CoV-2 in Healthcare Workers
NCT ID: NCT04370119
Last Updated: 2025-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1092 participants
OBSERVATIONAL
2020-04-27
2025-04-27
Brief Summary
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Detailed Description
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Over a 5 year period, a maximum of 12 study visits per participant are planned. At each visit, nasal/throat swabs (for PCR testing) and/or blood samples (to assess immunological responses, e.g. for SARS-CoV-2 antibody testing) will be collected. This will help to gain a better understanding of viral load and immunological responses, e.g. antibody development and their effects over time.
At study visit 2 - 12, participants will also be asked to fill in a questionnaire (asking for SARS-CoV-2 risk factors, perceived risk, impact of the pandemic on their quality of life, their interest in getting a SARS-CoV-2 vaccine/their SARS-CoV-2 vaccination status and vaccination side effects).
The remaining blood samples will be stored in a repository for future research.
The study is part of a modular SARS-CoV-2-research programme of the University Medicine Greifswald.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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(1) Healthcare workers
All healthcare workers at University Medicine Greifswald who were enrolled in the study between 04/2020-08/2020
Nasal swab
SARS-CoV-2 PCR
Serum testing
Anti-SARS-CoV2 S protein IgG ELISA, serological changes after SARS-CoV-2 vaccination
(2) Healthcare workers in high-risk areas of the hospital (intensive care, emergency medicine)
Healthcare workers at University Medicine Greifswald who were enrolled in the study between 01/2021-03/2021
Nasal swab
SARS-CoV-2 PCR
Serum testing
Anti-SARS-CoV2 S protein IgG ELISA, serological changes after SARS-CoV-2 vaccination
(3) Healthcare workers after SARS-CoV-2 vaccination
Healthcare workers at University Medicine Greifswald who received a SARS-CoV-2 vaccination within the last 7-21 days
Nasal swab
SARS-CoV-2 PCR
Serum testing
Anti-SARS-CoV2 S protein IgG ELISA, serological changes after SARS-CoV-2 vaccination
Interventions
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Nasal swab
SARS-CoV-2 PCR
Serum testing
Anti-SARS-CoV2 S protein IgG ELISA, serological changes after SARS-CoV-2 vaccination
Eligibility Criteria
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Inclusion Criteria
2. Willing and able to complete a written consent form
3. Willing to have blood samples stored for future research
4. Healthcare worker employed at Greifswald University Hospital
Exclusion Criteria
2. Decline to participate
18 Years
ALL
Yes
Sponsors
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Friedrich Loefler Institute for Animal Health
UNKNOWN
EUROIMMUN AG
UNKNOWN
University Medicine Greifswald
OTHER
Responsible Party
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Principal Investigators
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Nils-Olaf Hübner, Prof.Dr.
Role: PRINCIPAL_INVESTIGATOR
University Medicine Greifswald
Karsten Becker, Prof.Dr.
Role: PRINCIPAL_INVESTIGATOR
University Medicine Greifswald
Locations
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Greifswald University Medicine
Greifswald, , Germany
Countries
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References
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Esefeld M, Handtke S, Kaiser R, Nicolai L, Di Fina L, Rossaro D, Wesche J, Rath J, Wienrich AC, Hoffmann T, Harasser L, Feistritzer C, Loacker L, Lotfi K, Holmstrom M, Antovic J, Steil L, Volker U, Ulm L, Becker K, Hubner NO, Greinacher A, Thiele T. Platelet-activating histone/antihistone IgG complexes in anti-PF4-negative thrombosis and thrombocytopenia syndrome. Blood Adv. 2025 Aug 26;9(16):4323-4335. doi: 10.1182/bloodadvances.2024015076.
Handtke S, Wolff M, Zaninetti C, Wesche J, Schonborn L, Aurich K, Ulm L, Hubner NO, Becker K, Thiele T, Greinacher A. A flow cytometric assay to detect platelet-activating antibodies in VITT after ChAdOx1 nCov-19 vaccination. Blood. 2021 Jul 1;137(26):3656-3659. doi: 10.1182/blood.2021012064.
Other Identifiers
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BB 068/20
Identifier Type: -
Identifier Source: org_study_id
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