COVID-19: Herd Immunity Study in the Czech Republic

NCT04401085 | Completed

• 1 other identifier: UZIS 2020/1
• Study Type: observational
• Target: 27,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COVID; SARS-CoV 2

Keywords

SARS-CoV-2; prevalence; asymptomatic infection; spread dynamics

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Estimation of the proportion of people with a subclinical course of the disease

  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.

  May 2020

• Estimation of the proportion of persons suitable for the donation of convalescent plasma

  May 2020

Study Arms (3)

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.

Diagnostic Test: SARS-CoV-2 diagnostic rapid test

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: SARS-CoV-2 diagnostic rapid test; Diagnostic Test: Quantitative analysis of SARS-CoV-2 antibodies

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.

Diagnostic Test: SARS-CoV-2 diagnostic rapid test

Interventions

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.

Chronically ill patients cohort; Population area cohort - Control Cohort; Population cohort from specific geographical areas

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).

Population cohort from specific geographical areas

Eligibility Criteria

• Age: 8 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

Sponsors & Collaborators

• Institute of Health Information and Statistics of the Czech Republic: lead
• Ministry of Health, Czech Republic: collaborator
• Palacky University: collaborator
• Masaryk University: collaborator
• University of Ostrava: collaborator
• Faculty of Military Health Sciences, University of Defence in Brno: collaborator
• Faculty of Health Studies, J. E. Purkyně University in Ústí nad Labem: collaborator
• Charles University, Czech Republic: collaborator
• Institute for Clinical and Experimental Medicine: collaborator
• General University Hospital, Prague: collaborator
• University Hospital Olomouc: collaborator
• Brno University Hospital: collaborator
• Krajská zdravotní, a.s., Ústí nad Labem Region Hospitals: collaborator
• Military University Hospital, Prague: collaborator
• Masaryk Memorial Cancer Institute: collaborator
• Czech Academy of Sciences: collaborator
• Czech Statistical Office: collaborator

Study Sites (1)

Institute of Health Information and Statistics of the Czech Republic

Prague, 128 01, Czechia

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Only in one region, venous blood sampling will be archived in the biobank for subsequent quantitative analyses.

MeSH Terms

Conditions

Asymptomatic Infections

Condition Hierarchy (Ancestors)

Infections; Asymptomatic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2020
• First Posted: May 26, 2020
• Study Start: April 23, 2020
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2020
• Last Updated: June 1, 2020

Record last verified: 2020-05

Locations

CZ (1)