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

SARS-CoV-2 Clinical Trial

— SeCo  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04370119
• Other study ID #: BB 068/20
• Status: Active, not recruiting
• Start date: April 27, 2020
• Est. completion date: May 2025

Study information

• Verified date: May 2024
• Source: University Medicine Greifswald
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1092
• Est. completion date: May 2025
• Est. primary completion date: April 23, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. >= 18 years of age

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:

1. < 18 years of age

2. Decline to participate

Related Conditions & MeSH terms

• SARS-CoV-2

Intervention

Diagnostic Test:
• Nasal swab
SARS-CoV-2 PCR
• Serum testing
Anti-SARS-CoV2 S protein IgG ELISA, serological changes after SARS-CoV-2 vaccination

Locations

Country	Name	City	State
Germany	Greifswald University Medicine	Greifswald

Sponsors (3)

Lead Sponsor	Collaborator
University Medicine Greifswald	EUROIMMUN AG, Friedrich Loefler Institute for Animal Health

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	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	2 years
Other	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
Other	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
Other	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
Other	Number of people with detectable SARS-CoV-2 nucleic acid	SARS-CoV-2 PCR	2 years
Other	Number of people with detectable SARS-CoV-2 nucleic acid	SARS-CoV-2 PCR	3 years
Other	Number of people with detectable SARS-CoV-2 nucleic acid	SARS-CoV-2 PCR	4 years
Other	Number of people with detectable SARS-CoV-2 nucleic acid	SARS-CoV-2 PCR	5 years
Other	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
Other	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
Other	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
Other	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
Other	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
Other	Serological changes after SARS-CoV-2 vaccination	Serological changes after SARS-CoV-2 vaccination, cohort 3 only	7 days to 6 months after vaccination
Primary	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	Number of people with detectable SARS-CoV-2 nucleic acid	SARS-CoV-2 PCR	First study visit (baseline)