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

Study Overview
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Brief Summary
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Project is designed as a comprehensive population-based epidemiological study in Upper-Silesian Conurbation (Poland) aiming at: analysis of available data on incidence and mortality due to COVID-19 and 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.

Detailed Description
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Project is designed as a comprehensive population-based epidemiological study in Upper-Silesian Conurbation (Poland) aiming at: analysis of available data on incidence and mortality due to COVID-19 and 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.

Official Title
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Prevalence and Risk Factors of COVID-19 Infection in the Upper Silesian Agglomeration Population in 2020

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

Intervention / Treatment
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* Diagnostic Test: IgM and IgG antibodies assay


Participation Criteria
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Eligibility Criteria
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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. -
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Screened arm<br>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. | Diagnostic Test: IgM and IgG antibodies assay<br>* 5 ml venous blood sample collection to assay IgM and IgM against COVID19<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimation of prevalence of specific anti-SARS-CoV-2 IgM and IgG antibodies in general population. | Estimation of real prevalence of elevated IgM and IgG COVID antibodies in general population will allow to estimate real number of current and past COVID infection in the population. | 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of asymptomatic course of COVID in individuals with anti-SARS-CoV2 antibodies | Prevalence of asymptomatic cases into seropositive population | 8 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Covid19, Risk factors, Prevalence, Mortality, anti-SARS-CoV-2 antibodies