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| Name | Class |
|---|---|
| Ministry of Health, Czech Republic | OTHER_GOV |
| Palacky University | OTHER |
| Masaryk University | OTHER |
| University of Ostrava |
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The aim of the SARS-CoV-2-CZ-Preval study is to quantify the prevalence of individuals with a history of SARS-CoV-2 coronavirus infection in the Czech population, except for those diagnosed with COVID-19 by methods based on direct detection of SARS-CoV- 2, including individuals with a subclinical course of the disease.
COVID-19 is caused by a new type of coronavirus called SARS-CoV-2. It is a highly infectious disease, manifested mainly by fever, respiratory problems, muscle pain, and fatigue. However, despite the publication of hundreds of papers in the literature, fundamental information about the spread and course of the disease is still lacking in COVID-19. One of such key pieces of information is the prevalence of asymptomatic individuals with SARS-CoV-2 infection, which has a significant effect on the dynamics of the spread of COVID-19 in the Czech Republic and within individual regions and localities.
The SARS-CoV-2-CZ-Preval study is aiming at quantification of the prevalence of individuals with a history of SARS-CoV-2 coronavirus infection in the Czech population, except for those diagnosed with COVID-19 by methods based on direct detection of SARS-CoV- 2, including individuals with a subclinical course of the disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Population area cohort - Control Cohort | A population cohort of asymptomatic individuals (only adults). This is a representative sample of the population, which are part of the research project of Institute for Clinical and Experimental Medicine and Czech Academy of Sciences. The second subsample included individuals from the official household survey of Czech Statistical Office. This cohort allowed better comparative analysis of other population cohorts from specific geographical areas. |
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| Population cohort from specific geographical areas | This cohort is based on epidemiologically defined demographic parameters. These are populations from the following geographical areas: Brno and the South Moravian Region; Praha; Olomouc; Litoměřice; Litovel and Uničov. |
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| Chronically ill patients cohort | A cohort of chronically ill people enrolled by Institute for Clinical and Experimental Medicine with chronic cardiovascular problems, hypertension, or diabetes. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SARS-CoV-2 diagnostic rapid test | Diagnostic Test | The rapid test detects the presence of antibodies against SARS-CoV-2 in the IgM and IgG class by the immunochromatographic reaction. It cannot detect early infection, the antibodies will probably appear two weeks after possible infection. The collection will be performed by finger puncture. |
| Measure | Description | Time Frame |
|---|---|---|
| Estimation of the actual prevalence of SARS-CoV-2 positive persons in the Czech Republic. | Statistically, the primary objective is formulated as an estimate of the cumulative prevalence of SARS-CoV-2 positive individuals in geographically defined subpopulations of the Czech Republic with declared reliability of +/- 2%. For this primary objective, the required sample size in individual geographical cohorts is calculated. The positivity of SARS-CoV-2 individuals who have not been diagnosed with COVID-19 by a standard route of the detection will be assessed by the presence of specific IgM or IgG antibodies in the blood (antibody tests). | May 2020 |
| Measure | Description | Time Frame |
|---|---|---|
| Estimation of the proportion of people with a subclinical course of the disease | The proportion of SARS-CoV-2 positive persons who, according to the questionnaire, will not report any or minimal symptoms in the anamnesis. | May 2020 |
| Estimation of the cumulative prevalence of the disease and the proportion of people with a subclinical course differences between subcohorts according to demographic, social and clinically relevant stratifications. |
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Inclusion Criteria:
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The population area cohort is chosen based on random selection. The cohort from specific demographic areas are volunteers from the regions described in the cohort. The population of chronically ill people is a cohort enrolled by Institute for Clinical and Experimental Medicine.
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| Name | Affiliation | Role |
|---|---|---|
| Roman Chlíbek, Prof. | University of Defence in Brno | Study Director |
| Rastislav Maďar, Assoc. Prof. | University of Ostrava, Faculy of Medicine | Study Director |
| Marián Hajdúch, Assoc. Prof. | Institute of Molecular and Translational Medicine | Study Director |
| Ladislav Dušek, Prof. | Institute of Health Information and Statistics of the Czech Republic | Study Director |
| Roman Prymula, Prof. | Ministry of Health, Czech Republic | Study Chair |
| Jarmila Rážová, M.D.; Ph.D. | Ministry of Health, Czech Republic | Study Chair |
| Věra Adámková, Prof. | Institute for Clinical and Experimental Medicine | Principal Investigator |
| Aleksi Šedo, Prof. | Charles University, First Faculty of Medicine | Principal Investigator |
| Vladimír Černý, Prof. | Charles University, Faculty of Medicine in Hradec Králové |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Health Information and Statistics of the Czech Republic | Prague | 128 01 | Czechia |
It is not yet known if there will be a plan to make IPD available
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| ID | Term |
|---|---|
| D058345 | Asymptomatic Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D058070 | Asymptomatic Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
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| OTHER |
| Faculty of Military Health Sciences, University of Defence in Brno | UNKNOWN |
| Faculty of Health Studies, J. E. Purkyně University in Ústí nad Labem | UNKNOWN |
| Charles University, Czech Republic | OTHER |
| Institute for Clinical and Experimental Medicine | OTHER_GOV |
| General University Hospital, Prague | OTHER |
| University Hospital Olomouc | OTHER |
| Brno University Hospital | OTHER |
| Krajská zdravotní, a.s., Ústí nad Labem Region Hospitals | UNKNOWN |
| Military University Hospital, Prague | OTHER |
| Masaryk Memorial Cancer Institute | OTHER |
| Czech Academy of Sciences | OTHER |
| Czech Statistical Office | UNKNOWN |
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Only in one region, venous blood sampling will be archived in the biobank for subsequent quantitative analyses.
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| Quantitative analysis of SARS-CoV-2 antibodies | Diagnostic Test | The subsample from Olomouc region (Olomouc, Uničov, Litovel) is based on venous blood sampling and archiving for subsequent quantitative analysis of SARS-CoV-2 antibodies. These tests detect immunoglobulins M and G (IgM and IgG). |
|
| May 2020 |
| Estimation of the proportion of persons suitable for the donation of convalescent plasma | The estimation will be calculated according to the prevalence of the disease in the population after excluding contraindications to blood donation (age, health status, etc.). | May 2020 |
| Principal Investigator |
| Jaroslav Štěrba, Prof. | Brno University Hospital | Principal Investigator |
| David Feltl, Prof. | General University Hospital, Prague | Principal Investigator |
| Martin Repko, Prof. | Masaryk University, Faculty of Medicine | Principal Investigator |
| Dalibor Valík, Prof. | Masaryk Memorial Cancer Institute | Principal Investigator |
| Zdeněk Havel, Assoc. Prof. | J. E. Purkyně University in Ústí nad Labem, Faculty of Health Studies | Principal Investigator |
| D013568 |
| Pathological Conditions, Signs and Symptoms |