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COVID-19: Herd Immunity Study in the Czech Republic

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StatusCompleted
Sponsors
Institute of Health Information and Statistics of the Czech Republic
Collaborators
Ministry of Health, Czech Republic
Faculty of Medicine, Palacky University
Faculty of Medicine, Masaryk University
Faculty of medicine, University of Ostrava
Faculty of Military Health Sciences, University of Defence in Brno
Faculty of Health Studies, J. E. Purkyně University in Ústí nad Labem
First Faculty of Medicine, Charles University, Czech Republic
Institute for Clinical and Experimental Medicine
General University Hospital, Prague
University Hospital Olomouc
Brno University Hospital
Krajská zdravotní, a.s., Ústí nad Labem Region Hospitals
Military University Hospital, Prague
Masaryk Memorial Cancer Institute
Institute Of Sociology, Czech Academy of Sciences
Czech Statistical Office
Faculty of Medicine in Hradec Králové, Charles University

Keywords

Abstract

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.

Description

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.

Dates

Last Verified: 04/30/2020
First Submitted: 05/20/2020
Estimated Enrollment Submitted: 05/20/2020
First Posted: 05/25/2020
Last Update Submitted: 05/28/2020
Last Update Posted: 05/31/2020
Actual Study Start Date: 04/22/2020
Estimated Primary Completion Date: 04/30/2020
Estimated Study Completion Date: 04/30/2020

Condition or disease

COVID
SARS-CoV 2

Intervention/treatment

Diagnostic Test: SARS-CoV-2 diagnostic rapid test

Diagnostic Test: Population cohort from specific geographical areas

Phase

-

Arm Groups

ArmIntervention/treatment
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.
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.
Diagnostic Test: Population cohort from specific geographical areas
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.

Eligibility Criteria

Ages Eligible for Study 8 Years To 8 Years
Sexes Eligible for StudyAll
Sampling methodNon-Probability Sample
Accepts Healthy VolunteersYes
Criteria

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

Outcome

Primary Outcome Measures

1. Estimation of the actual prevalence of SARS-CoV-2 positive persons in the Czech Republic. [May 2020]

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).

Secondary Outcome Measures

1. Estimation of the proportion of people with a subclinical course of the disease [May 2020]

The proportion of SARS-CoV-2 positive persons who, according to the questionnaire, will not report any or minimal symptoms in the anamnesis.

2. 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. [May 2020]

3. Estimation of the proportion of persons suitable for the donation of convalescent plasma [May 2020]

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.).

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