Prevalence and Risk Factors of COVID-19 in the Upper Silesian Agglomeration (EpiSARS2)

Medical University of Silesia

Status: Unknown

Conditions: Corona Virus Infection; RNA Virus Infections; Severe Acute Respiratory Syndrome; Covid19; Respiratory Tract Disease; Respiratory Tract Infections; Virus Disease

Treatments: Diagnostic Test: IgM and IgG antibodies assay

Study type: Observational

Funder types: Other

Identifiers

NCT04627623

2020/ABM /COVID19/0044

Details and patient eligibility

About

Project is designed as a comprehensive population-based epidemiological study in Upper-Silesian Conurbation (Poland) aiming at:

1. analysis of available data on incidence and mortality due to COVID-19 and
2. estimation of the occurrence of viral infection SARS-CoV-2 as revealed by the results of serological test (ELISA: IgM, IgG), with assessment of risk factors.

The project's objectives are: to assess incidence and mortality due COVID-19 according to sex, age and coexisting diseases; to determine the level of potential "underdiagnosis" of the magnitude of COVID-19 mortality using vital statistics data for Upper-Silesian Conurbation; to assess the prevalence of SARS-CoV-2 based on the level of seropositivity in Upper-Silesian Conurbation; to identify host-related and environmental risk factors if the infection. Analysis of existing data will include monthly records on incidence and mortality over the period 01.01.2020-31.12.2020 and comparison of the findings with the monthly records of 2018 and 2019, for the same population. Cross-sectional epidemiological study will be located in three towne (Katowice, Sosnowiec, Gliwice). In each town a representative age-stratified sample of 2000 subjects will undergo questionnaire assessment and serological examination performed by serological test. The project corresponds with analogous population-based studies on COVID-19 in a number of countries and responds to the WHO recommendation in that field.

Full description

Project is designed as a comprehensive population-based epidemiological study in Upper-Silesian Conurbation (Poland) aiming at:

1. analysis of available data on incidence and mortality due to COVID-19 and
2. estimation of the occurrence of viral infection SARS-CoV-2 as revealed by the results of serological test (ELISA: IgM, IgG), with assessment of risk factors.

The project's objectives are: to assess incidence and mortality due COVID-19 according to sex, age and coexisting diseases; to determine the level of potential "underdiagnosis" of the magnitude of COVID-19 mortality using vital statistics data for Upper-Silesian Conurbation; to assess the prevalence of SARS-CoV-2 based on the level of seropositivity in Upper-Silesian Conurbation; to identify host-related and environmental risk factors if the infection. Analysis of existing data will include monthly records on incidence and mortality over the period 01.01.2020-31.12.2020 and comparison of the findings with the monthly records of 2018 and 2019, for the same population. Cross-sectional epidemiological study will be located in three towne (Katowice, Sosnowiec, Gliwice). In each town a representative age-stratified sample of 2000 subjects will undergo questionnaire assessment and serological examination performed by serological test. The project corresponds with analogous population-based studies on COVID-19 in a number of countries and responds to the WHO recommendation in that field.

Enrollment: 6,000 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: citizens of one of three towns (Katowice, Sosnowiec, Gliwice) with no age limits

Exclusion Criteria: person who is not able to contact laboratory and obtain blood sample.

Trial design

6,000 participants in 1 patient group

Screened arm

Description:

6000 peoples (3x2000) in all ages randomly selected from the general population of three towns (Katowice, Sosnowiec, Gliwice). From all invited is collected a venous blood samples (5ml) to assay IgM and IgG antibodies.

Treatment:

Diagnostic Test: IgM and IgG antibodies assay