Clinical trial NCT04401085: COVID-19: Herd Immunity Study in the Czech Republic
Official title: Herd Immunity Study SARS-CoV-2-CZ-Preval
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID
SARS-CoV 2
Keywords: SARS-CoV-2
prevalence
asymptomatic infection
spread dynamics
Lead sponsor: Institute of Health Information and Statistics of the Czech Republic
Sponsor class: OTHER_GOV
Collaborators: name: Ministry of Health, Czech Republic
name: Palacky University
name: Masaryk University
name: University of Ostrava
name: Faculty of Military Health Sciences, University of Defence in Brno
name: Faculty of Health Studies, J. E. Purkyně University in Ústí nad Labem
name: Charles University, Czech Republic
name: Institute for Clinical and Experimental Medicine
name: General University Hospital, Prague
name: University Hospital Olomouc
name: Brno University Hospital
name: Krajská zdravotní, a.s., Ústí nad Labem Region Hospitals
name: Military University Hospital, Prague
name: Masaryk Memorial Cancer Institute
name: Czech Academy of Sciences
name: Czech Statistical Office
name: Faculty of Medicine in Hradec Králové, Charles University
First posted: 2020-05-26
Enrollment: 27000
Sex: ALL
Minimum age (years): 8
Maximum age (years): 89
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.

Eligibility 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

Primary outcomes:
measure: Estimation of the actual prevalence of SARS-CoV-2 positive persons in the Czech Republic.
timeFrame: May 2020
Secondary outcomes:
measure: Estimation of the proportion of people with a subclinical course of the disease
timeFrame: May 2020
measure: 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.
timeFrame: May 2020
measure: Estimation of the proportion of persons suitable for the donation of convalescent plasma
timeFrame: May 2020
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Institute of Health Information and Statistics of the Czech Republic
Study officials:
affiliation: University of Defence in Brno
name: Roman Chlíbek, Prof.
role: STUDY_DIRECTOR
affiliation: University of Ostrava, Faculy of Medicine
name: Rastislav Maďar, Assoc. Prof.
role: STUDY_DIRECTOR
affiliation: Institute of Molecular and Translational Medicine
name: Marián Hajdúch, Assoc. Prof.
role: STUDY_DIRECTOR
affiliation: Institute of Health Information and Statistics of the Czech Republic
name: Ladislav Dušek, Prof.
role: STUDY_DIRECTOR
affiliation: Ministry of Health, Czech Republic
name: Roman Prymula, Prof.
role: STUDY_CHAIR
affiliation: Ministry of Health, Czech Republic
name: Jarmila Rážová, M.D.; Ph.D.
role: STUDY_CHAIR
affiliation: Institute for Clinical and Experimental Medicine
name: Věra Adámková, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Charles University, First Faculty of Medicine
name: Aleksi Šedo, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Charles University, Faculty of Medicine in Hradec Králové
name: Vladimír Černý, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Brno University Hospital
name: Jaroslav Štěrba, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: General University Hospital, Prague
name: David Feltl, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Masaryk University, Faculty of Medicine
name: Martin Repko, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Masaryk Memorial Cancer Institute
name: Dalibor Valík, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: J. E. Purkyně University in Ústí nad Labem, Faculty of Health Studies
name: Zdeněk Havel, Assoc. Prof.
role: PRINCIPAL_INVESTIGATOR
References: