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| Name | Class |
|---|---|
| Friedrich Loefler Institute for Animal Health | UNKNOWN |
| EUROIMMUN AG | UNKNOWN |
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The main objectives of this study are 1) to establish the prevalence of SARS-CoV-2 in asymptomatic healthcare workers (HCWs) in an early phase of community spread as well as 2) to monitor the future spread of the disease by assessing serological responses to SARS-CoV-2 in symptomatic and asymptomatic HCWs over time and 3) to improve the assessment of the immune response and its protective effect as well as the assessment of infectivity of affected HCWs and 4) to evaluate the value and significance of antibody formation and serological antibody tests and 5) to be able to evaluate possible future preventive and / or therapeutic approaches against SARS-CoV-2, e.g. to assess vaccination effects
This study aims to collect information on staff working at the Greifswald University hospital.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| (1) Healthcare workers | All healthcare workers at University Medicine Greifswald who were enrolled in the study between 04/2020-08/2020 |
| |
| (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 |
| |
| (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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nasal swab | Diagnostic Test | SARS-CoV-2 PCR |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of people with detectable antibodies to SARS-CoV-2 | Anti-SARS-CoV-2 S protein IgG ELISA/ Anti-SARS-CoV-2 NCP IgG ELISA | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Number of people with detectable SARS-CoV-2 nucleic acid | SARS-CoV-2 PCR | First study visit (baseline) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of people with detectable antibodies to SARS-CoV-2 | Anti-SARS-CoV-2 S protein IgG ELISA/ Anti-SARS-CoV-2 NCP IgG ELISA | First study visit (baseline) |
| Number of people with detectable antibodies to SARS-CoV-2 |
Inclusion Criteria:
Exclusion Criteria:
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Health Care Worker
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| Name | Affiliation | Role |
|---|---|---|
| Nils-Olaf Hübner, Prof.Dr. | University Medicine Greifswald | Principal Investigator |
| Karsten Becker, Prof.Dr. | University Medicine Greifswald | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Greifswald University Medicine | Greifswald | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40179418 | Derived | 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. | |
| 33945605 |
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Serum, nasal/throat swabs
| Serum testing | Diagnostic Test | Anti-SARS-CoV2 S protein IgG ELISA, serological changes after SARS-CoV-2 vaccination |
|
Anti-SARS-CoV-2 S protein IgG ELISA/ Anti-SARS-CoV-2 NCP IgG ELISA
| 2 years |
| Number of people with detectable antibodies to SARS-CoV-2 | Anti-SARS-CoV-2 S protein IgG ELISA/ Anti-SARS-CoV-2 NCP IgG ELISA | 3 years |
| Number of people with detectable antibodies to SARS-CoV-2 | Anti-SARS-CoV-2 S protein IgG ELISA/ Anti-SARS-CoV-2 NCP IgG ELISA | 4 years |
| Number of people with detectable antibodies to SARS-CoV-2 | Anti-SARS-CoV-2 S protein IgG ELISA/ Anti-SARS-CoV-2 NCP IgG ELISA | 5 years |
| Number of people with detectable SARS-CoV-2 nucleic acid | SARS-CoV-2 PCR | 2 years |
| Number of people with detectable SARS-CoV-2 nucleic acid | SARS-CoV-2 PCR | 3 years |
| Number of people with detectable SARS-CoV-2 nucleic acid | SARS-CoV-2 PCR | 4 years |
| Number of people with detectable SARS-CoV-2 nucleic acid | SARS-CoV-2 PCR | 5 years |
| SARS-CoV-2 risk factors, perceived risk of infection, impact of the pandemic on quality of life, vaccination interest/vaccination status, vaccination side effects | As assessed by a questionnaire | 1 year |
| SARS-CoV-2 risk factors, perceived risk of infection, impact of the pandemic on quality of life, vaccination interest/vaccination status, vaccination side effects | As assessed by a questionnaire | 2 years |
| SARS-CoV-2 risk factors, perceived risk of infection, impact of the pandemic on quality of life, vaccination interest/vaccination status, vaccination side effects | As assessed by a questionnaire | 3 years |
| SARS-CoV-2 risk factors, perceived risk of infection, impact of the pandemic on quality of life, vaccination interest/vaccination status, vaccination side effects | As assessed by a questionnaire | 4 years |
| SARS-CoV-2 risk factors, perceived risk of infection, impact of the pandemic on quality of life, vaccination interest/vaccination status, vaccination side effects | As assessed by a questionnaire | 5 years |
| Serological changes after SARS-CoV-2 vaccination | Serological changes after SARS-CoV-2 vaccination, cohort 3 only | 7 days to 6 months after vaccination |
| Derived |
| 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. |