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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04354779
Other study ID # AUVA SARS-CoV-2 Studie
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 11, 2020
Est. completion date September 28, 2020

Study information

Verified date September 2020
Source AUVA
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Context: On March 11, the World Health Organization (WHO) announced the current corona virus disease 2019 (COVID-19) outbreak as a pandemic. The first laboratory-confirmed case of COVID-19 in Austria was announced on February 27, 2020. Since then, the incidence of infection follows a gradual increase. Measurements taken by the Austrian government include travel restrictions, closing of national borders, social distancing, a mandatory use of facemasks in public, and closing of stores and restaurants. The underlying aim of those imposed restrictions is to contain the viral transmission and to slow spreading of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

Objectives: The aims of this study are to determine i) how many employees in Austrian trauma hospitals and rehabilitation facilities have virus specific IgG and IgM antibodies against SARS-CoV-2, ii) how many are active virus carriers (symptomatic and asymptomatic), iii) how many employees are in their incubation period during the study period, and iv) to calculate the SARS-CoV-2 prevalence together with a specific occupation associated infection risk within the different specifications of health care workers.

Study Design: Open uncontrolled observational cross-sectional study.

Setting/Participants: A total of 4000 employees in 11 Austrian trauma hospitals and rehabilitation facilities of the Austrian Social Insurance for Occupational Risks (AUVA) will be invited to participate in the study.

Study Interventions and Measures: An antibody test for SARS-CoV-2 specific IgG and IgM antibodies, and a RT-PCR test based on oropharyngeal swab samples, as well as laboratory-based antibody tests using ELISA, will be implemented to ensure protection and preservation of health in hospital staff and are not part of the study. The tests will be conducted twice, with approximately two weeks in between testing. The results of the tests will be used for statistical analysis in this study together with a questionnaire including questions related to personal health, traveling activities, living situation, as well as inquiries of symptoms and comorbidities.


Recruitment information / eligibility

Status Completed
Enrollment 3301
Est. completion date September 28, 2020
Est. primary completion date August 23, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 15 Years to 90 Years
Eligibility Inclusion Criteria:

- employees in Austrian trauma hospitals and rehabilitation facilities of the Austrian Social Insurance for Occupational Risks (AUVA)

Exclusion Criteria:

- NA

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
a specifically designed self-administered questionnaire
The questionnaire consists of the following items: questions related to personal health, traveling activities, living situation, as well as inquiries of symptoms and comorbidities.

Locations

Country Name City State
Austria Allgemeine Unfallversicherungsanstalt Vienna

Sponsors (2)

Lead Sponsor Collaborator
AUVA Paracelsus Medical University

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary Antibody status in HCW To determine how many employees in Austrian trauma hospitals and rehabilitation facilities have already virus specific IgG and IgM antibodies against SARS-CoV-2. 4 months
Primary Active virus carriers in HCW To determine how many are actively infected with or without showing symptoms. 4 months
Primary Incubation time To determine how many employees are in their incubation period during study time. 4 months
Secondary Background incidence rate To evaluate the "background incidence rate" of COVID-19 to calculate the SARS-CoV-2 prevalence in a defined cohort of the Austrian population. 4 months
Secondary Occupation associated infection risk To calculate a specific occupation associated infection risk within the different specifications of health care workers amongst AUVA employees. 4 months
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