SeCo: Screening for COVID-19 and Monitoring of Serological Responses to SARS-CoV-2 in Healthcare Workers
Study Details
Study Description
Brief Summary
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
This study aims to collect information on staff working at the Greifswald University hospital.
Over a 5 year period, a maximum of 6 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 - 6, 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| (1) Healthcare workers All healthcare workers at University Medicine Greifswald who were enrolled in the study between 04/2020-08/2020 |
Diagnostic Test: Nasal swab
SARS-CoV-2 PCR
Diagnostic Test: 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 |
Diagnostic Test: Nasal swab
SARS-CoV-2 PCR
Diagnostic Test: 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 |
Diagnostic Test: Nasal swab
SARS-CoV-2 PCR
Diagnostic Test: Serum testing
Anti-SARS-CoV2 S protein IgG ELISA, serological changes after SARS-CoV-2 vaccination
|
Outcome Measures
Primary Outcome Measures
- Number of people with detectable antibodies to SARS-CoV-2 [1 year]
Anti-SARS-CoV-2 S protein IgG ELISA/ Anti-SARS-CoV-2 NCP IgG ELISA
Secondary Outcome Measures
- Number of people with detectable SARS-CoV-2 nucleic acid [First study visit (baseline)]
SARS-CoV-2 PCR
Other Outcome Measures
- Number of people with detectable antibodies to SARS-CoV-2 [First study visit (baseline)]
Anti-SARS-CoV-2 S protein IgG ELISA/ Anti-SARS-CoV-2 NCP IgG ELISA
- Number of people with detectable antibodies to SARS-CoV-2 [2 years]
Anti-SARS-CoV-2 S protein IgG ELISA/ Anti-SARS-CoV-2 NCP IgG ELISA
- Number of people with detectable antibodies to SARS-CoV-2 [3 years]
Anti-SARS-CoV-2 S protein IgG ELISA/ Anti-SARS-CoV-2 NCP IgG ELISA
- Number of people with detectable antibodies to SARS-CoV-2 [4 years]
Anti-SARS-CoV-2 S protein IgG ELISA/ Anti-SARS-CoV-2 NCP IgG ELISA
- Number of people with detectable antibodies to SARS-CoV-2 [5 years]
Anti-SARS-CoV-2 S protein IgG ELISA/ Anti-SARS-CoV-2 NCP IgG ELISA
- Number of people with detectable SARS-CoV-2 nucleic acid [2 years]
SARS-CoV-2 PCR
- Number of people with detectable SARS-CoV-2 nucleic acid [3 years]
SARS-CoV-2 PCR
- Number of people with detectable SARS-CoV-2 nucleic acid [4 years]
SARS-CoV-2 PCR
- Number of people with detectable SARS-CoV-2 nucleic acid [5 years]
SARS-CoV-2 PCR
- SARS-CoV-2 risk factors, perceived risk of infection, impact of the pandemic on quality of life, vaccination interest/vaccination status, vaccination side effects [1 year]
As assessed by a questionnaire
- SARS-CoV-2 risk factors, perceived risk of infection, impact of the pandemic on quality of life, vaccination interest/vaccination status, vaccination side effects [2 years]
As assessed by a questionnaire
- SARS-CoV-2 risk factors, perceived risk of infection, impact of the pandemic on quality of life, vaccination interest/vaccination status, vaccination side effects [3 years]
As assessed by a questionnaire
- SARS-CoV-2 risk factors, perceived risk of infection, impact of the pandemic on quality of life, vaccination interest/vaccination status, vaccination side effects [4 years]
As assessed by a questionnaire
- SARS-CoV-2 risk factors, perceived risk of infection, impact of the pandemic on quality of life, vaccination interest/vaccination status, vaccination side effects [5 years]
As assessed by a questionnaire
- Serological changes after SARS-CoV-2 vaccination [7 days to 6 months after vaccination]
Serological changes after SARS-CoV-2 vaccination, cohort 3 only
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Greifswald University Medicine | Greifswald | Germany |
Sponsors and Collaborators
- University Medicine Greifswald
- Friedrich Loefler Institute for Animal Health
- EUROIMMUN AG
Investigators
- Principal Investigator: Nils-Olaf Hübner, Prof.Dr., University Medicine Greifswald
- Principal Investigator: Karsten Becker, Prof.Dr., University Medicine Greifswald
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BB 068/20