COVID-19: Herd Immunity Study in the Czech Republic

Completed

• Conditions: COVID; SARS-CoV 2
• Interventions: Diagnostic Test: SARS-CoV-2 diagnostic rapid test; Diagnostic Test: Quantitative analysis of SARS-CoV-2 antibodies

• Registration Number: NCT04401085
• Lead Sponsor: Institute of Health Information and Statistics of the Czech Republic

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.

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 Timeline

• Study Start: 2020-04-23
• Status Verified: 2020-05
• Primary Completion: 2020-05-01
• Study Completion: 2020-05-01
• Study First Submitted: 2020-05-21
• Study First Submitted QC: 2020-05-21
• Study First Posted: 2020-05-26
• Last Update Submitted: 2020-05-29
• Last Update Posted: 2020-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27000

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Chronically ill patients cohort	SARS-CoV-2 diagnostic rapid test	A cohort of chronically ill people enrolled by Institute for Clinical and Experimental Medicine with chronic cardiovascular problems, hypertension, or diabetes.
Population cohort from specific geographical areas	SARS-CoV-2 diagnostic rapid test	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.
Population cohort from specific geographical areas	Quantitative analysis of SARS-CoV-2 antibodies	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.
Population area cohort - Control Cohort	SARS-CoV-2 diagnostic rapid test	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.).
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.
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

Trial Locations

Locations (1)

Institute of Health Information and Statistics of the Czech Republic; 🇨🇿 Prague, Czechia