SARS-CoV-2VIVINCT04407429
Vienna Versus SARS-CoV-2 Virus Study
An observational study of SARS-CoV-2 and COVID-19, run by Medical University of Vienna at 1 site in Austria.
Trial summary
This study examines the seroprevalence against SARS-CoV-2 in health care workers and patients at the Vienna General Hospital. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV-2, COVID-19
- What is being tested?
- Laboratory Analyses
- How many people
- 12,000 participants
- Where
- 1 siteAustria
- Study dates
- 27 May 2020to 27 Jun 2021
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Cohort A: Health care workers Cohort B: Patients admitted for non-COVID related symptoms
Who may be able to join
- Physicians
- Nursing staff
- Midwives
- Medical-technical assistants (including medical, therapeutic and diagnostic healthcare staff, and medical and nursing assistants)
- Administrative personnel with patient contact
- ● Patients with available residual serum samples
Who cannot join
- Not employed at the Medical University of Vienna or the Vienna General Hospital
- No signed informed consent
- Cohort B:
- ● Serum samples from COVID-19 triage units at the Vienna General Hospital
Trial locations and contacts
1 site in 1 country.
Christian Hengstenberg, Univ.-Prof. contact
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna
Vienna, 1090
Christian Hengstenberg, Univ.-Prof., +43 1 40400 ext. 46140, christian.hengstenberg@meduniwien.ac.at
Thomas A Zelniker, DDr., +43 1 40400 ext. 46140, thomas.zelniker@meduniwien.ac.at
About this study
Official title: Vienna Versus SARS-CoV-2 Virus: A Prospective Large-scale Antibody Study of SARS-CoV-2 in Patients and Health Care Workers
This study examines the seroprevalence against SARS-CoV-2 in health care workers and patients at the Vienna General Hospital.
Read the detailed description
This study consists of 2 parts: a longitudinal study enrolling 3,000 health care professionals at the Vienna General Hospital testing their antibody status 6 times over a period of 12 months (Cohort A), and a serial cross-sectional study of 3,000 patients (i.e., a total of 9,000 patients) admitted to the Vienna General Hospital for non-COVID-19-related symptoms at 3 different time points during this pandemic (Cohort B).
- Conditions
- SARS-CoV-2, COVID-19
- Being tested
- Laboratory Analyses
- Keywords
- COVID-19, SARS-CoV-2, Immunity, Antibodies, Virus, Respiratory Virus, Immunoglobulins
- Medical subject headings
- COVID-19, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laboratory AnalysesDiagnostic test
Storage of serum for SARS-CoV-2-antibodies and biomarkers
| Study group | Role | What they receive |
|---|---|---|
| Health care workers | Physicians, Nursing staff, Midwives, Medical-technical assistants (including medical, therapeutic and diagnostic healthcare staff, and medical and nursing assistants), administrative personnel with patient contact Receives: Diagnostic Test: Laboratory Analyses | |
| Patients | Patients admitted for non-COVID related symptoms to the Vienna General Hospital with available residual serum samples. Receives: Diagnostic Test: Laboratory Analyses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of antibody status in healthcare workers and in patients admitted for non-COVID-19 related symptoms over time
Measured: 1 year
Secondary outcomes (2)
Incidence rate of sero-conversion
Measured: 1 year
Identification of risk markers/factors for SARS-CoV-2 infection
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2020
- Study start27 May 2020
- Primary completion27 Jun 2021 (estimated)
- Study completion27 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SARS-CoV-2Studies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- 12,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christian Hengstenberg, Medical University of Vienna
- Investigators
- Christian Hengstenberg, Univ.-Prof., Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04407429
- Sponsor's protocol ID
- EK 1387/2020
- Acronym
- VIVI
- Status last verified
- May 2020
- First submitted
- 27 May 2020
- Last updated
- 29 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Riesenhuber M, Nitsche C, Binder CJ, Schernhammer ES, Stamm T, Jakse F, Anwari E, Hamidi F, Haslacher H, Perkmann T, Hengstenberg C, Zelniker TA. Comparison of the prevalence of SARS-CoV-2 nucleoprotein antibodies in healthcare workers and an unselected adult and paediatric all-comer patient population: insights from a longitudinal study of healthcare workers and concurrent serial cross-sectional studies of patients at an academic medical centre in Austria. BMJ Open. 2023 Jan 18;13(1):e063760. doi: 10.1136/bmjopen-2022-063760.
PubMed 36657754
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vienna Versus SARS-CoV-2 Virus: A Prospective Large-scale Antibody Study of SARS-CoV-2 in Patients and Health Care Workers
- ClinicalTrials.gov ID
- NCT04407429
- Acronym / sponsor ID
- VIVI / EK 1387/2020
- Conditions
- SARS-CoV-2, COVID-19
- Keywords
- COVID-19, SARS-CoV-2, Immunity, Antibodies, Virus, Respiratory Virus, Immunoglobulins
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 12,000 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 27 May 2020 (actual)
- Primary completion
- 27 Jun 2021 (estimated)
- Study completion
- 27 Jun 2021 (estimated)
- First posted
- 29 May 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.
This study examines the seroprevalence against SARS-CoV-2 in health care workers and patients at the Vienna General Hospital.
Detailed description
This study consists of 2 parts: a longitudinal study enrolling 3,000 health care professionals at the Vienna General Hospital testing their antibody status 6 times over a period of 12 months (Cohort A), and a serial cross-sectional study of 3,000 patients (i.e., a total of 9,000 patients) admitted to the Vienna General Hospital for non-COVID-19-related symptoms at 3 different time points during this pandemic (Cohort B).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Health care workers | – | Diagnostic Test: Laboratory AnalysesPhysicians, Nursing staff, Midwives, Medical-technical assistants (including medical, therapeutic and diagnostic healthcare staff, and medical and nursing assistants), administrative personnel with patient contact |
| Patients | – | Diagnostic Test: Laboratory AnalysesPatients admitted for non-COVID related symptoms to the Vienna General Hospital with available residual serum samples. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Cohort A: Health care workers Cohort B: Patients admitted for non-COVID related symptoms
Key inclusion criteria (6 listed)
- Physicians
- Nursing staff
- Midwives
- Medical-technical assistants (including medical, therapeutic and diagnostic healthcare staff, and medical and nursing assistants)
- Administrative personnel with patient contact
Key exclusion criteria (4 listed)
- Not employed at the Medical University of Vienna or the Vienna General Hospital
- No signed informed consent
- ● Serum samples from COVID-19 triage units at the Vienna General Hospital
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 |
|---|---|---|
| Laboratory AnalysesStorage of serum for SARS-CoV-2-antibodies and biomarkers | Diagnostic test | Health care workers, Patients |
Primary outcome
Prevalence of antibody status in healthcare workers and in patients admitted for non-COVID-19 related symptoms over time
Time frame: 1 year
2 secondary outcomes
Incidence rate of sero-conversion
Time frame: 1 year
Identification of risk markers/factors for SARS-CoV-2 infection
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2020.
- Derived from this study: PubMed 36657754Riesenhuber M, Nitsche C, Binder CJ, Schernhammer ES, Stamm T, Jakse F, Anwari E, Hamidi F, Haslacher H, Perkmann T, Hengstenberg C, Zelniker TA. Comparison of the prevalence of SARS-CoV-2 nucleoprotein antibodies in healthcare workers and an unselected adult and paediatric all-comer patient population: insights from a longitudinal study of healthcare workers and concurrent serial cross-sectional studies of patients at an academic medical centre in Austria. BMJ Open. 2023 Jan 18;13(1):e063760. doi: 10.1136/bmjopen-2022-063760.
- Individual participant dataSharing planned: Undecided
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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.
Christian Hengstenberg, Univ.-Prof. contact
Christian Hengstenberg, Univ.-Prof. principal investigator
Medical University of Vienna
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 and COVID-19, run by Medical University of Vienna at 1 site in Austria.
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 6 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 29 May 2020. 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 Austria. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christian Hengstenberg, Univ.-Prof. (+43 1 40400 ext. 46140, christian.hengstenberg@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of antibody status in healthcare workers and in patients admitted for non-COVID-19 related symptoms over time (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 NCT04407429, which also lists 1 linked publication.
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 29 May 2020; AzTrials last refreshed its copy on 28 Oct 2026.