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

NCT04370119 | Completed

• 1 other identifier: BB 068/20
• Study Type: observational
• Target: 1,092
• Locations: 1 country
• Sites: 1

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

Conditions

SARS-CoV-2

Keywords

Serology; antibody formation; epidemiology; immunity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of people with detectable SARS-CoV-2 nucleic acid

  First study visit (baseline)

Other Outcomes (15)

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

  First study visit (baseline)

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

  2 years

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

  3 years

Study Arms (3)

(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; Diagnostic Test: Serum testing

(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; Diagnostic Test: Serum testing

(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; Diagnostic Test: Serum testing

Interventions

Nasal swab DIAGNOSTIC_TEST

SARS-CoV-2 PCR

(1) Healthcare workers; (2) Healthcare workers in high-risk areas of the hospital (intensive care, emergency medicine); (3) Healthcare workers after SARS-CoV-2 vaccination

Serum testing DIAGNOSTIC_TEST

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

(1) Healthcare workers; (2) Healthcare workers in high-risk areas of the hospital (intensive care, emergency medicine); (3) Healthcare workers after SARS-CoV-2 vaccination

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Health Care Worker

You may qualify if:

• \>= 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

You may not qualify if:

• \< 18 years of age
• Decline to participate

Sponsors & Collaborators

• University Medicine Greifswald: lead
• Friedrich Loefler Institute for Animal Health: collaborator
• EUROIMMUN AG: collaborator

Study Sites (1)

Greifswald University Medicine

Greifswald, Germany

Location

Related Publications (2)

• 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.

  PMID: 40179418 DERIVED

• 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.

  PMID: 33945605 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum, nasal/throat swabs

Study Officials

• Nils-Olaf Hübner, Prof.Dr.

  University Medicine Greifswald

  PRINCIPAL INVESTIGATOR

• Karsten Becker, Prof.Dr.

  University Medicine Greifswald

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2020
• First Posted: April 30, 2020
• Study Start: April 27, 2020
• Primary Completion: April 23, 2021
• Study Completion: April 27, 2025
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)