Vienna Versus SARS-CoV-2 Virus Study (VIVI)

May 27, 2020 updated by: Christian Hengstenberg, Medical University of Vienna

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

12000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Recruiting
        • Medical University of Vienna
        • Contact:
        • Contact:
        • Principal Investigator:
          • Thomas A Zelniker, DDr.
        • Sub-Investigator:
          • Daniela Gompelmann, Prof.
        • Sub-Investigator:
          • Marco Idzko, Prof.
        • Sub-Investigator:
          • Christian Nitsche, Dr.
        • Sub-Investigator:
          • Rainer Oberbauer, Prof.
        • Sub-Investigator:
          • Thomas Perkmann, Dr.
        • Sub-Investigator:
          • Martin Riesenhuber, Dr.
        • Sub-Investigator:
          • Eva Schernhammer, Prof.
        • Sub-Investigator:
          • Tanja Stamm, Prof.
        • Sub-Investigator:
          • Christoph Binder, Prof.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Cohort A: Health care workers

Cohort B: Patients admitted for non-COVID related symptoms

Description

Cohort A:

Inclusion criteria:

  • Physicians
  • Nursing staff
  • Midwives
  • Medical-technical assistants (including medical, therapeutic and diagnostic healthcare staff, and medical and nursing assistants)
  • Administrative personnel with patient contact

Exclusion Criteria:

  • Not employed at the Medical University of Vienna or the Vienna General Hospital
  • No signed informed consent

Cohort B:

Inclusion Criteria:

● Patients with available residual serum samples

Exclusion Criteria:

● Serum samples from COVID-19 triage units at the Vienna General Hospital

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Diagnostic test: Laboratory Analyses
Storage of serum for SARS-CoV-2-antibodies and biomarkers
Patients
Patients admitted for non-COVID related symptoms to the Vienna General Hospital with available residual serum samples.
Diagnostic test: Laboratory Analyses
Storage of serum for SARS-CoV-2-antibodies and biomarkers

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Prevalence of antibody status in healthcare workers and in patients admitted for non-COVID-19 related symptoms over time
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence rate of sero-conversion
Time Frame: 1 year
1 year
Identification of risk markers/factors for SARS-CoV-2 infection
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Investigators

  • Principal Investigator: Christian Hengstenberg, Univ.-Prof., Medical University of Vienna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 27, 2020

Primary Completion (Anticipated)

June 27, 2021

Study Completion (Anticipated)

June 27, 2021

Study Registration Dates

First Submitted

May 27, 2020

First Submitted That Met QC Criteria

May 27, 2020

First Posted (Actual)

May 29, 2020

Study Record Updates

Last Update Posted (Actual)

May 29, 2020

Last Update Submitted That Met QC Criteria

May 27, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EK 1387/2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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