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

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ClinicalTrials.gov Identifier: NCT04627623
Recruitment Status : Recruiting
First Posted : November 13, 2020
Last Update Posted : November 17, 2020
Sponsor:
Information provided by (Responsible Party):
Prof. Grzegorz Brożek, MD PhD, 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.


Condition or disease Intervention/treatment
Covid19 Respiratory Tract Infections Severe Acute Respiratory Syndrome Corona Virus Infection RNA Virus Infections Virus Disease Respiratory Tract Disease 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.

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Study Type : Observational
Estimated 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 : June 22, 2020
Estimated Primary Completion Date : March 22, 2021
Estimated Study Completion Date : April 22, 2021

Resource links provided by the National Library of Medicine


Group/Cohort 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




Primary Outcome Measures :
  1. Estimation of prevalence of specific anti-SARS-CoV-2 IgM and IgG antibodies in general population. [ Time Frame: 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 [ Time Frame: 8 months ]
    Prevalence of asymptomatic cases into seropositive population


Biospecimen Retention:   Samples With DNA
5 ml venous blood sample


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Selected by random inhabitants of one of three towns (Katowice, Sosnowiec, Gliwice) with no age limits.
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.

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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04627623


Contacts
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Contact: Grzegorz M Brozek, Prof 0048 693 700 184 gbrozek@sum.edu.pl

Locations
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Poland
Diagnostyka sp zoo Recruiting
Katowice, Poland, 40-282
Contact: Rafał Trela    0048 728331386    rafal.trela@diag.pl   
Sponsors and Collaborators
Medical University of Silesia
Investigators
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Principal Investigator: Jan E Zejda, Prof Medical University of Silesia in Katowice Poland
Publications:
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Responsible Party: Prof. Grzegorz Brożek, MD PhD, Medical University of Silesia
ClinicalTrials.gov Identifier: NCT04627623    
Other Study ID Numbers: 2020/ABM /COVID19/0044
First Posted: November 13, 2020    Key Record Dates
Last Update Posted: November 17, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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, Medical University of Silesia:
Covid19
Risk factors
Prevalence
Mortality
anti-SARS-CoV-2 antibodies
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Respiratory Tract Infections
Virus Diseases
Severe Acute Respiratory Syndrome
Coronavirus Infections
RNA Virus Infections
Respiratory Tract Diseases
Coronaviridae Infections
Nidovirales Infections
Antibodies
Immunologic Factors
Physiological Effects of Drugs