SARS-CoV-2SeCoNCT04370119
Screening for COVID-19 and Monitoring of Serological Responses to SARS-CoV-2 in Healthcare Workers
An observational study of SARS-CoV-2, run by University Medicine Greifswald at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV-2
- What is being tested?
- Nasal swab and Serum testing
- Type of treatment
- Vaccines
- How many people
- 1,092 participants
- Where
- 1 siteGermany
- Study dates
- 27 Apr 2020to 27 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Health Care Worker
Who may be able to join
- >= 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
Who cannot join
- < 18 years of age
- Decline to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Screening for SARS-CoV-2-Infections 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
Read the detailed 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.
- Conditions
- SARS-CoV-2
- Being tested
- Nasal swab, Serum testing
- Keywords
- Serology, antibody formation, epidemiology, immunity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal swabDiagnostic test
SARS-CoV-2 PCR
Serum testingDiagnostic test
Anti-SARS-CoV2 S protein IgG ELISA, serological changes after SARS-CoV-2 vaccination
| Study group | Role | What they receive |
|---|---|---|
| (1) Healthcare workers | All healthcare workers at University Medicine Greifswald who were enrolled in the study between 04/2020-08/2020 Receives: 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 Receives: 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 Receives: Diagnostic Test: Nasal swab; Diagnostic Test: Serum testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (1)
Number of people with detectable SARS-CoV-2 nucleic acid
SARS-CoV-2 PCR
Measured: First study visit (baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2020
- Study start27 Apr 2020
- Primary completion23 Apr 2021
- Study completion27 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SARS-CoV-2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,092 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medicine Greifswald
- Sponsor type
- University, hospital or other
- Collaborators
- Friedrich Loefler Institute for Animal Health, EUROIMMUN AG
- Responsible party
- Sponsor
- Investigators
- Nils-Olaf Hübner, Prof.Dr., Principal investigator, University Medicine GreifswaldKarsten Becker, Prof.Dr., Principal investigator, University Medicine Greifswald
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04370119
- Sponsor's protocol ID
- BB 068/20
- Acronym
- SeCo
- Status last verified
- Nov 2025
- First submitted
- 29 Apr 2020
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40179418Handtke 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.
PubMed 33945605
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening for SARS-CoV-2-Infections and Monitoring of Serological Responses to SARS-CoV-2 in Healthcare Workers
- ClinicalTrials.gov ID
- NCT04370119
- Acronym / sponsor ID
- SeCo / BB 068/20
- Conditions
- SARS-CoV-2
- Keywords
- Serology, antibody formation, epidemiology, immunity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,092 participants (actual)
- Lead sponsor
- University Medicine GreifswaldUniversity, hospital or other
- Collaborators
- Friedrich Loefler Institute for Animal Health, EUROIMMUN AG
- Study start
- 27 Apr 2020 (actual)
- Primary completion
- 23 Apr 2021 (actual)
- Study completion
- 27 Apr 2025 (actual)
- First posted
- 30 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| (1) Healthcare workers | – | Diagnostic Test: Nasal swab, Diagnostic Test: Serum testingAll healthcare workers at University Medicine Greifswald who were enrolled in the study between 04/2020-08/2020 |
| (2) Healthcare workers in high-risk areas of the hospital (intensive care, emergency medicine) | – | Diagnostic Test: Nasal swab, Diagnostic Test: Serum testingHealthcare workers at University Medicine Greifswald who were enrolled in the study between 01/2021-03/2021 |
| (3) Healthcare workers after SARS-CoV-2 vaccination | – | Diagnostic Test: Nasal swab, Diagnostic Test: Serum testingHealthcare workers at University Medicine Greifswald who received a SARS-CoV-2 vaccination within the last 7-21 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Health Care Worker
Key inclusion criteria (4 listed)
- >= 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
Key exclusion criteria (2 listed)
- < 18 years of age
- Decline to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nasal swabSARS-CoV-2 PCR | Diagnostic test | (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 testingAnti-SARS-CoV2 S protein IgG ELISA, serological changes after SARS-CoV-2 vaccination | Diagnostic test | (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 |
Primary outcome
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
1 secondary outcome
Number of people with detectable SARS-CoV-2 nucleic acid
Time frame: First study visit (baseline)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Derived from this study: PubMed 40179418Esefeld 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.
- Derived from this study: PubMed 33945605Handtke 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nils-Olaf Hübner, Prof.Dr. principal investigator
University Medicine Greifswald
Karsten Becker, Prof.Dr. principal investigator
University Medicine Greifswald
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS-CoV-2, run by University Medicine Greifswald at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of people with detectable antibodies to SARS-CoV-2 (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04370119, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.