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

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

• Registration Number: NCT04627623
• Lead Sponsor: Medical University of Silesia

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2020-06-22
• Status Verified: 2020-11
• Study First Submitted: 2020-11-12
• Study First Submitted QC: 2020-11-12
• Study First Posted: 2020-11-13
• Last Update Submitted: 2020-11-13
• Last Update Posted: 2020-11-17
• Primary Completion: 2021-03-22
• Study Completion: 2021-04-22

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 6000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Estimation of prevalence of specific anti-SARS-CoV-2 IgM and IgG antibodies in general population.	8 months	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.

Secondary Outcome Measures

Name	Time	Method
Frequency of asymptomatic course of COVID in individuals with anti-SARS-CoV2 antibodies	8 months	Prevalence of asymptomatic cases into seropositive population

Trial Locations

Locations (1)

Diagnostyka sp zoo; 🇵🇱 Katowice, Poland