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

Covid19 Clinical Trial

— EpiSARS2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04627623
• Other study ID #: 2020/ABM /COVID19/0044
• Status: Recruiting
• Start date: June 22, 2020
• Est. completion date: April 22, 2021

Study information

• Verified date: November 2020
• Source: Medical University of Silesia
• Contact: Grzegorz M Brozek, Prof
• Phone: 0048 693 700 184
• Email: gbrozek[@]sum.edu.pl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6000
• Est. completion date: April 22, 2021
• Est. primary completion date: March 22, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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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Related Conditions & MeSH terms

• Communicable Diseases
• Corona Virus Infection
• Coronavirus Infections
• Covid19
• Infection
• Respiratory Tract Disease
• Respiratory Tract Diseases
• Respiratory Tract Infections
• RNA Virus Infections
• Severe Acute Respiratory Syndrome
• Virus Disease
• Virus Diseases

Intervention

Diagnostic Test:
• IgM and IgG antibodies assay
5 ml venous blood sample collection to assay IgM and IgM against COVID19

Locations

Country	Name	City	State
Poland	Diagnostyka sp zoo	Katowice

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Silesia

Country where clinical trial is conducted

Poland, 

References & Publications (4)

Lee CY, Lin RTP, Renia L, Ng LFP. Serological Approaches for COVID-19: Epidemiologic Perspective on Surveillance and Control. Front Immunol. 2020 Apr 24;11:879. doi: 10.3389/fimmu.2020.00879. eCollection 2020. Review. — View Citation

Li Z, Yi Y, Luo X, Xiong N, Liu Y, Li S, Sun R, Wang Y, Hu B, Chen W, Zhang Y, Wang J, Huang B, Lin Y, Yang J, Cai W, Wang X, Cheng J, Chen Z, Sun K, Pan W, Zhan Z, Chen L, Ye F. Development and clinical application of a rapid IgM-IgG combined antibody test for SARS-CoV-2 infection diagnosis. J Med Virol. 2020 Feb 27. doi: 10.1002/jmv.25727. [Epub ahead of print] — View Citation

Pan Y, Li X, Yang G, Fan J, Tang Y, Zhao J, Long X, Guo S, Zhao Z, Liu Y, Hu H, Xue H, Li Y. Serological immunochromatographic approach in diagnosis with SARS-CoV-2 infected COVID-19 patients. J Infect. 2020 Jul;81(1):e28-e32. doi: 10.1016/j.jinf.2020.03.051. Epub 2020 Apr 10. — View Citation

Zhao J, Yuan Q, Wang H, Liu W, Liao X, Su Y, Wang X, Yuan J, Li T, Li J, Qian S, Hong C, Wang F, Liu Y, Wang Z, He Q, Li Z, He B, Zhang T, Fu Y, Ge S, Liu L, Zhang J, Xia N, Zhang Z. Antibody responses to SARS-CoV-2 in patients of novel coronavirus disease 2019. Clin Infect Dis. 2020 Mar 28. pii: ciaa344. doi: 10.1093/cid/ciaa344. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Frequency of asymptomatic course of COVID in individuals with anti-SARS-CoV2 antibodies	Prevalence of asymptomatic cases into seropositive population	8 months