Screening for COVID-19 and Monitoring of Serological Responses to SARS-CoV-2 in Healthcare Workers

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Screening for SARS-CoV-2-Infections and Monitoring of Serological Responses to SARS-CoV-2 in Healthcare Workers

Conditions
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SARS-CoV-2

Intervention / Treatment
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* Diagnostic Test: Nasal swab
* Diagnostic Test: Serum testing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >= 18 years of age Willing and able to complete a written consent form Willing to have blood samples stored for future research Healthcare worker employed at Greifswald University Hospital Exclusion Criteria: < 18 years of age Decline to participate

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| (1) Healthcare workers<br>All healthcare workers at University Medicine Greifswald who were enrolled in the study between 04/2020-08/2020 | Diagnostic Test: Nasal swab<br>* SARS-CoV-2 PCR<br>Diagnostic Test: Serum testing<br>* Anti-SARS-CoV2 S protein IgG ELISA, serological changes after SARS-CoV-2 vaccination<br>|
| (2) Healthcare workers in high-risk areas of the hospital (intensive care, emergency medicine)<br>Healthcare workers at University Medicine Greifswald who were enrolled in the study between 01/2021-03/2021 | Diagnostic Test: Nasal swab<br>* SARS-CoV-2 PCR<br>Diagnostic Test: Serum testing<br>* Anti-SARS-CoV2 S protein IgG ELISA, serological changes after SARS-CoV-2 vaccination<br>|
| (3) Healthcare workers after SARS-CoV-2 vaccination<br>Healthcare workers at University Medicine Greifswald who received a SARS-CoV-2 vaccination within the last 7-21 days | Diagnostic Test: Nasal swab<br>* SARS-CoV-2 PCR<br>Diagnostic Test: Serum testing<br>* Anti-SARS-CoV2 S protein IgG ELISA, serological changes after SARS-CoV-2 vaccination<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of people with detectable SARS-CoV-2 nucleic acid | SARS-CoV-2 PCR | First study visit (baseline) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Serology, antibody formation, epidemiology, immunity