COVID-19: Herd Immunity Study in the Czech Republic

COVID Clinical Trial

— SARSCoV2CZPrev  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04401085
• Other study ID #: UZIS 2020/1
• Status: Completed
• Start date: April 23, 2020
• Est. completion date: May 1, 2020

Study information

• Verified date: May 2020
• Source: Institute of Health Information and Statistics of the Czech Republic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27000
• Est. completion date: May 1, 2020
• Est. primary completion date: May 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID
• SARS-CoV 2

Intervention

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.
• Quantitative analysis of SARS-CoV-2 antibodies
The subsample from Olomouc region (Olomouc, Unicov, 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).

Locations

Country	Name	City	State
Czechia	Institute of Health Information and Statistics of the Czech Republic	Prague

Sponsors (18)

Lead Sponsor

Collaborator

Institute of Health Information and Statistics of the Czech Republic

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

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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