Antibody Seroprevalence and Rate of Asymptomatic Infections With SARS-CoV-2 in Austrian Hospital Personnel.

Covid19 Clinical Trial

Official title:

Antikörperseroprävalenz Und Hintergrundinfektionsrate Von SARS-CoV-2 in Einem österreichischen Schlüsselkollektiv an Arbeitnehmer*Innen

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04354779
• Other study ID #: AUVA SARS-CoV-2 Studie
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Coronavirus Infection
• Coronavirus Infections
• Covid19
• Infection
• SARS-CoV 2
• Severe Acute Respiratory Syndrome
• Severe Acute Respiratory Syndrome Coronavirus 2

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