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NCT04407429 Clinical Trial

Vienna Versus SARS-CoV-2 Virus Study

COVID-19 Clinical Trial

— VIVI  

Official title:
Vienna Versus SARS-CoV-2 Virus: A Prospective Large-scale Antibody Study of SARS-CoV-2 in Patients and Health Care Workers

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04407429
Other study ID # EK 1387/2020
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 27, 2020
Est. completion date June 27, 2021

Study information
Verified date May 2020
Source Medical University of Vienna
Contact Christian Hengstenberg, Univ.-Prof.
Phone +43 1 40400
Email christian.hengstenberg@meduniwien.ac.at
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study examines the seroprevalence against SARS-CoV-2 in health care workers and patients at the Vienna General Hospital.

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).

Recruitment information / eligibility
Status Recruiting
Enrollment 12000
Est. completion date June 27, 2021
Est. primary completion date June 27, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Laboratory Analyses
Storage of serum for SARS-CoV-2-antibodies and biomarkers

Locations
Country Name City State
Austria Medical University of Vienna Vienna

Sponsors (1)
Lead Sponsor Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome
Type Measure Description Time frame Safety issue
Primary Prevalence of antibody status in healthcare workers and in patients admitted for non-COVID-19 related symptoms over time 1 year
Secondary Incidence rate of sero-conversion 1 year
Secondary Identification of risk markers/factors for SARS-CoV-2 infection 1 year
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