Clinical trial NCT04627623: Prevalence and Risk Factors of COVID-19 in the Upper Silesian Agglomeration
Official title: Prevalence and Risk Factors of COVID-19 Infection in the Upper Silesian Agglomeration Population in 2020
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
Respiratory Tract Infections
Severe Acute Respiratory Syndrome
Corona Virus Infection
RNA Virus Infections
Virus Disease
Respiratory Tract Disease
Keywords: Covid19
Risk factors
Prevalence
Mortality
anti-SARS-CoV-2 antibodies
Lead sponsor: Medical University of Silesia
Sponsor class: OTHER
First posted: 2020-11-13
Enrollment: 6000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Selected by random inhabitants of one of three towns (Katowice, Sosnowiec, Gliwice) with no age limits.

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.

Eligibility 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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Primary outcomes:
measure: Estimation of prevalence of specific anti-SARS-CoV-2 IgM and IgG antibodies in general population.
timeFrame: 8 months
Secondary outcomes:
measure: Frequency of asymptomatic course of COVID in individuals with anti-SARS-CoV2 antibodies
timeFrame: 8 months
Other outcomes:
Locations:
city: Katowice
country: Poland
facility: Diagnostyka sp zoo
Study officials:
affiliation: Medical University of Silesia in Katowice Poland
name: Jan E Zejda, Prof
role: PRINCIPAL_INVESTIGATOR
References:
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.
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 Sep;92(9):1518-1524. doi: 10.1002/jmv.25727. Epub 2020 Apr 13.
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 With Novel Coronavirus Disease 2019. Clin Infect Dis. 2020 Nov 19;71(16):2027-2034. doi: 10.1093/cid/ciaa344.
citation: 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.