COVID-19: Herd Immunity Study in the Czech Republic (SARSCoV2CZPrev)

Herd Immunity Study SARS-CoV-2-CZ-Preval

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.

Study Overview

• Status: Completed
• Conditions: SARS-CoV 2; COVID
• Intervention / Treatment: Diagnostic test: SARS-CoV-2 diagnostic rapid test; Diagnostic test: Quantitative analysis of SARS-CoV-2 antibodies

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 27000

Contacts and Locations

Study Locations

• Czechia
  • Prague, Czechia, 128 01
    • Institute of Health Information and Statistics of the Czech Republic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 85 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / 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.	Diagnostic test: 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.
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; 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.; 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).
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.		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

Collaborators and Investigators

• Sponsor: Institute of Health Information and Statistics of the Czech Republic
• Collaborators: Charles University, Czech Republic; Institute for Clinical and Experimental Medicine; Brno University Hospital; University Hospital Olomouc; University of Ostrava; Palacky University; Masaryk University; General University Hospital, Prague; Masaryk Memorial Cancer Institute; Military University Hospital, Prague; Czech Academy of Sciences; Ministry of Health, Czech Republic; Faculty of Military Health Sciences, University of Defence in Brno; Faculty of Health Studies, J. E. Purkyně University in Ústí nad Labem; Krajská zdravotní, a.s., Ústí nad Labem Region Hospitals; Czech Statistical Office; Faculty of Medicine in Hradec Králové, Charles University
• Investigators: Study Director: 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 Chair: Roman Prymula, Prof., Ministry of Health, Czech Republic; Study Chair: Jarmila Rážová, M.D.; Ph.D., Ministry of Health, Czech Republic; Principal Investigator: 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 Kralove; 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: Zdeněk Havel, Assoc. Prof., J. E. Purkyně University in Ústí nad Labem, Faculty of Health Studies

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2020
• Primary Completion (Actual): May 1, 2020
• Study Completion (Actual): May 1, 2020

Study Registration Dates

• First Submitted: May 21, 2020
• First Submitted That Met QC Criteria: May 21, 2020
• First Posted (Actual): May 26, 2020

Study Record Updates

• Last Update Posted (Actual): June 1, 2020
• Last Update Submitted That Met QC Criteria: May 29, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: SARS-CoV-2; prevalence; asymptomatic infection; spread dynamics
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunologic Factors; Antibodies
• Other Study ID Numbers: UZIS 2020/1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: It is not yet known if there will be a plan to make IPD available

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No