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Completed

NCT Number: NCT04370119

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

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

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Greifswald University Medicine

Greifswald, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

nasal swab

Diagnostic Test

SARS-CoV-2 PCR

Serum testing

Diagnostic Test

Anti-SARS-CoV2 S protein IgG ELISA, serological changes after SARS-CoV-2 vaccination

Primary outcomes

  1. Number of people with detectable antibodies to SARS-CoV-2

    Time frame: 1 year

    Anti-SARS-CoV-2 S protein IgG ELISA/ Anti-SARS-CoV-2 NCP IgG ELISA

Secondary outcomes

  1. Number of people with detectable SARS-CoV-2 nucleic acid

    Time frame: First study visit (baseline)

    SARS-CoV-2 PCR

Other outcomes

  1. Number of people with detectable antibodies to SARS-CoV-2

    Time frame: First study visit (baseline)

    Anti-SARS-CoV-2 S protein IgG ELISA/ Anti-SARS-CoV-2 NCP IgG ELISA

  2. Number of people with detectable antibodies to SARS-CoV-2

    Time frame: 2 years

    Anti-SARS-CoV-2 S protein IgG ELISA/ Anti-SARS-CoV-2 NCP IgG ELISA

  3. Number of people with detectable antibodies to SARS-CoV-2

    Time frame: 3 years

    Anti-SARS-CoV-2 S protein IgG ELISA/ Anti-SARS-CoV-2 NCP IgG ELISA

  4. Number of people with detectable antibodies to SARS-CoV-2

    Time frame: 4 years

    Anti-SARS-CoV-2 S protein IgG ELISA/ Anti-SARS-CoV-2 NCP IgG ELISA

  5. Number of people with detectable antibodies to SARS-CoV-2

    Time frame: 5 years

    Anti-SARS-CoV-2 S protein IgG ELISA/ Anti-SARS-CoV-2 NCP IgG ELISA

  6. Number of people with detectable SARS-CoV-2 nucleic acid

    Time frame: 2 years

    SARS-CoV-2 PCR

  7. Number of people with detectable SARS-CoV-2 nucleic acid

    Time frame: 3 years

    SARS-CoV-2 PCR

  8. Number of people with detectable SARS-CoV-2 nucleic acid

    Time frame: 4 years

    SARS-CoV-2 PCR

  9. Number of people with detectable SARS-CoV-2 nucleic acid

    Time frame: 5 years

    SARS-CoV-2 PCR

  10. SARS-CoV-2 risk factors, perceived risk of infection, impact of the pandemic on quality of life, vaccination interest/vaccination status, vaccination side effects

    Time frame: 1 year

    As assessed by a questionnaire

  11. SARS-CoV-2 risk factors, perceived risk of infection, impact of the pandemic on quality of life, vaccination interest/vaccination status, vaccination side effects

    Time frame: 2 years

    As assessed by a questionnaire

  12. SARS-CoV-2 risk factors, perceived risk of infection, impact of the pandemic on quality of life, vaccination interest/vaccination status, vaccination side effects

    Time frame: 3 years

    As assessed by a questionnaire

  13. SARS-CoV-2 risk factors, perceived risk of infection, impact of the pandemic on quality of life, vaccination interest/vaccination status, vaccination side effects

    Time frame: 4 years

    As assessed by a questionnaire

  14. SARS-CoV-2 risk factors, perceived risk of infection, impact of the pandemic on quality of life, vaccination interest/vaccination status, vaccination side effects

    Time frame: 5 years

    As assessed by a questionnaire

  15. Serological changes after SARS-CoV-2 vaccination

    Time frame: 7 days to 6 months after vaccination

    Serological changes after SARS-CoV-2 vaccination, cohort 3 only

Sponsors and collaborators

Lead sponsor

University Medicine Greifswald

Other

Collaborators

  • EUROIMMUN AG
  • Friedrich Loefler Institute for Animal Health

Registry information

Official study title

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

Acronym: SeCo

Important dates

Study start
2020
Primary completion
2021
Study completion
2025
First posted
Apr 30, 2020
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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