COVID-19: Herd Immunity Study in the Czech Republic

NCT ID: NCT04401085

Last Updated: 2020-06-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

27000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-23

Study Completion Date

2020-05-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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COVID SARS-CoV 2

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

SARS-CoV-2 diagnostic rapid test

Intervention Type 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.

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.

SARS-CoV-2 diagnostic rapid test

Intervention Type 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.

Quantitative analysis of SARS-CoV-2 antibodies

Intervention Type 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).

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.

SARS-CoV-2 diagnostic rapid test

Intervention Type 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.

Interventions

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SARS-CoV-2 diagnostic rapid 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.

Intervention Type DIAGNOSTIC_TEST

Quantitative analysis of SARS-CoV-2 antibodies

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).

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* signed Informed Consent
* residing in The Czech Republic
* demographic criteria: (i) persons aged 8-17 (specific children's cohort), (ii) persons aged 18-89
* clinical criteria: (i) without acute health problems (ii) without a confirmed diagnosis of COVID-19
* geographic criteria: according to a particular cohort definition
Minimum Eligible Age

8 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ministry of Health, Czech Republic

OTHER_GOV

Sponsor Role collaborator

Palacky University

OTHER

Sponsor Role collaborator

Masaryk University

OTHER

Sponsor Role collaborator

University of Ostrava

OTHER

Sponsor Role collaborator

Faculty of Military Health Sciences, University of Defence in Brno

UNKNOWN

Sponsor Role collaborator

Faculty of Health Studies, J. E. Purkyně University in Ústí nad Labem

UNKNOWN

Sponsor Role collaborator

Charles University, Czech Republic

OTHER

Sponsor Role collaborator

Institute for Clinical and Experimental Medicine

OTHER_GOV

Sponsor Role collaborator

General University Hospital, Prague

OTHER

Sponsor Role collaborator

University Hospital Olomouc

OTHER

Sponsor Role collaborator

Brno University Hospital

OTHER

Sponsor Role collaborator

Krajská zdravotní, a.s., Ústí nad Labem Region Hospitals

UNKNOWN

Sponsor Role collaborator

Military University Hospital, Prague

OTHER

Sponsor Role collaborator

Masaryk Memorial Cancer Institute

OTHER

Sponsor Role collaborator

Czech Academy of Sciences

OTHER

Sponsor Role collaborator

Czech Statistical Office

UNKNOWN

Sponsor Role collaborator

Faculty of Medicine in Hradec Králové, Charles University

UNKNOWN

Sponsor Role collaborator

Institute of Health Information and Statistics of the Czech Republic

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Roman Chlíbek, Prof.

Role: STUDY_DIRECTOR

University of Defence in Brno

Rastislav Maďar, Assoc. Prof.

Role: STUDY_DIRECTOR

University of Ostrava, Faculy of Medicine

Marián Hajdúch, Assoc. Prof.

Role: STUDY_DIRECTOR

Institute of Molecular and Translational Medicine

Ladislav Dušek, Prof.

Role: STUDY_DIRECTOR

Institute of Health Information and Statistics of the Czech Republic

Roman Prymula, Prof.

Role: STUDY_CHAIR

Ministry of Health, Czech Republic

Jarmila Rážová, M.D.; Ph.D.

Role: STUDY_CHAIR

Ministry of Health, Czech Republic

Věra Adámková, Prof.

Role: PRINCIPAL_INVESTIGATOR

Institute for Clinical and Experimental Medicine

Aleksi Šedo, Prof.

Role: PRINCIPAL_INVESTIGATOR

Charles University, First Faculty of Medicine

Vladimír Černý, Prof.

Role: PRINCIPAL_INVESTIGATOR

Charles University, Faculty of Medicine in Hradec Králové

Jaroslav Štěrba, Prof.

Role: PRINCIPAL_INVESTIGATOR

Brno University Hospital

David Feltl, Prof.

Role: PRINCIPAL_INVESTIGATOR

General University Hospital, Prague

Martin Repko, Prof.

Role: PRINCIPAL_INVESTIGATOR

Masaryk University, Faculty of Medicine

Dalibor Valík, Prof.

Role: PRINCIPAL_INVESTIGATOR

Masaryk Memorial Cancer Institute

Zdeněk Havel, Assoc. Prof.

Role: PRINCIPAL_INVESTIGATOR

J. E. Purkyně University in Ústí nad Labem, Faculty of Health Studies

Locations

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Institute of Health Information and Statistics of the Czech Republic

Prague, , Czechia

Site Status

Countries

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Czechia

Other Identifiers

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UZIS 2020/1

Identifier Type: -

Identifier Source: org_study_id

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