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

NCT ID: NCT04370119

Last Updated: 2025-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1092 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-27

Study Completion Date

2025-04-27

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.

Conditions

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SARS-CoV-2

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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(1) Healthcare workers

All healthcare workers at University Medicine Greifswald who were enrolled in the study between 04/2020-08/2020

Nasal swab

Intervention Type DIAGNOSTIC_TEST

SARS-CoV-2 PCR

Serum testing

Intervention Type DIAGNOSTIC_TEST

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

Nasal swab

Intervention Type DIAGNOSTIC_TEST

SARS-CoV-2 PCR

Serum testing

Intervention Type DIAGNOSTIC_TEST

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

Nasal swab

Intervention Type DIAGNOSTIC_TEST

SARS-CoV-2 PCR

Serum testing

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Nasal swab

SARS-CoV-2 PCR

Intervention Type DIAGNOSTIC_TEST

Serum testing

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Friedrich Loefler Institute for Animal Health

UNKNOWN

Sponsor Role collaborator

EUROIMMUN AG

UNKNOWN

Sponsor Role collaborator

University Medicine Greifswald

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nils-Olaf Hübner, Prof.Dr.

Role: PRINCIPAL_INVESTIGATOR

University Medicine Greifswald

Karsten Becker, Prof.Dr.

Role: PRINCIPAL_INVESTIGATOR

University Medicine Greifswald

Locations

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Greifswald University Medicine

Greifswald, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 40179418 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33945605 (View on PubMed)

Other Identifiers

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BB 068/20

Identifier Type: -

Identifier Source: org_study_id

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