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

Sponsor
Medical University of Silesia (Other)
Overall Status
Recruiting
CT.gov ID
NCT04627623
Collaborator
(none)
6,000
1
10
600.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: IgM and IgG antibodies assay

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 Design

Study Type:
Observational
Anticipated Enrollment :
6000 participants
Observational Model:
Case-Crossover
Time Perspective:
Cross-Sectional
Official Title:
Prevalence and Risk Factors of COVID-19 Infection in the Upper Silesian Agglomeration Population in 2020
Actual Study Start Date :
Jun 22, 2020
Anticipated Primary Completion Date :
Mar 22, 2021
Anticipated Study Completion Date :
Apr 22, 2021

Arms and Interventions

Arm Intervention/Treatment
Screened arm

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
5 ml venous blood sample collection to assay IgM and IgM against COVID19

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Frequency of asymptomatic course of COVID in individuals with anti-SARS-CoV2 antibodies [8 months]

    Prevalence of asymptomatic cases into seropositive population

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

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.

-

Contacts and Locations

Locations

Site City State Country Postal Code
1 Diagnostyka sp zoo Katowice Poland 40-282

Sponsors and Collaborators

  • Medical University of Silesia

Investigators

  • Principal Investigator: Jan E Zejda, Prof, Medical University of Silesia in Katowice Poland

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Prof. Grzegorz Brożek, MD PhD, Prof. Grzegorz Brożek, MD PhD, Medical University of Silesia
ClinicalTrials.gov Identifier:
NCT04627623
Other Study ID Numbers:
  • 2020/ABM /COVID19/0044
First Posted:
Nov 13, 2020
Last Update Posted:
Nov 17, 2020
Last Verified:
Nov 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Prof. Grzegorz Brożek, MD PhD, Prof. Grzegorz Brożek, MD PhD, Medical University of Silesia
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 17, 2020