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NCT Number: NCT04401085

COVID-19: Herd Immunity Study in the Czech Republic

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.

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Key information

Conditions

COVID Asymptomatic Diseases Asymptomatic Infections Disease Attributes Infections Pathologic Processes Pathological Conditions, Signs and Symptoms SARS-CoV 2

Age range

8 year–89 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Institute of Health Information and Statistics of the Czech Republic

Prague, 128 01, Czechia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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).

Primary outcomes

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

    Time frame: 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 outcomes

  1. Estimation of the proportion of people with a subclinical course of the disease

    Time frame: 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.

    Time frame: May 2020

  3. Estimation of the proportion of persons suitable for the donation of convalescent plasma

    Time frame: 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.).

Sponsors and collaborators

Lead sponsor

Institute of Health Information and Statistics of the Czech Republic

Other Gov

Collaborators

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

Registry information

Official study title

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

Acronym: SARSCoV2CZPrev

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 26, 2020
Registry last updated
Jun 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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