COVIDSARSCoV2CZPrevNCT04401085
COVID-19: Herd Immunity Study in the Czech Republic
An observational study of COVID and SARS-CoV 2, run by Institute of Health Information and Statistics of the Czech Republic at 1 site in Czechia.
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. Read more about this study
- Who is it for?
- Ages 8 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID, SARS-CoV 2
- What is being tested?
- SARS-CoV-2 diagnostic rapid test and Quantitative analysis of SARS-CoV-2 antibodies
- How many people
- 27,000 participants
- Where
- 1 siteCzechia
- Study dates
- 23 Apr 2020to 1 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 89 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Czechia1 site
Institute of Health Information and Statistics of the Czech Republic
Prague, 128 01
About this study
Official title: 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.
Read the 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.
- Conditions
- COVID, SARS-CoV 2
- Being tested
- SARS-CoV-2 diagnostic rapid test, Quantitative analysis of SARS-CoV-2 antibodies
- Keywords
- SARS-CoV-2, prevalence, asymptomatic infection, spread dynamics
- Medical subject headings
- Asymptomatic Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SARS-CoV-2 diagnostic rapid testDiagnostic 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 antibodiesDiagnostic 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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: SARS-CoV-2 diagnostic rapid test | |
| 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. Receives: Diagnostic Test: SARS-CoV-2 diagnostic rapid test; Diagnostic Test: Quantitative analysis of SARS-CoV-2 antibodies | |
| 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. Receives: Diagnostic Test: SARS-CoV-2 diagnostic rapid test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: May 2020
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.).
Measured: May 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2020
- Study start23 Apr 2020
- Primary completion1 May 2020
- Study completion1 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVIDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 27,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Health Information and Statistics of the Czech Republic
- Sponsor type
- Other government
- Collaborators
- Ministry of Health, Czech Republic, Palacky University, Masaryk University, University of Ostrava, Faculty of Military Health Sciences, University of Defence in Brno, Faculty of Health Studies, J. E. Purkyně University in Ústí nad Labem, Charles University, Czech Republic, Institute for Clinical and Experimental Medicine, General University Hospital, Prague, University Hospital Olomouc, Brno University Hospital, Krajská zdravotní, a.s., Ústí nad Labem Region Hospitals, Military University Hospital, Prague, Masaryk Memorial Cancer Institute, Czech Academy of Sciences, Czech Statistical Office
- Responsible party
- Sponsor
- Investigators
- Roman Chlíbek, Prof., Study director, University of Defence in BrnoRastislav Maďar, Assoc. Prof., Study director, University of Ostrava, Faculy of MedicineMarián Hajdúch, Assoc. Prof., Study director, Institute of Molecular and Translational MedicineLadislav Dušek, Prof., Study director, Institute of Health Information and Statistics of the Czech RepublicRoman Prymula, Prof., Study chair, Ministry of Health, Czech RepublicJarmila Rážová, M.D.; Ph.D., Study chair, Ministry of Health, Czech RepublicVěra Adámková, Prof., Principal investigator, Institute for Clinical and Experimental MedicineAleksi Šedo, Prof., Principal investigator, Charles University, First Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04401085
- Sponsor's protocol ID
- UZIS 2020/1
- Acronym
- SARSCoV2CZPrev
- Status last verified
- May 2020
- First submitted
- 21 May 2020
- Last updated
- 1 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is not yet known if there will be a plan to make IPD available
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Herd Immunity Study SARS-CoV-2-CZ-Preval
- ClinicalTrials.gov ID
- NCT04401085
- Acronym / sponsor ID
- SARSCoV2CZPrev / UZIS 2020/1
- Conditions
- COVID, SARS-CoV 2
- Keywords
- SARS-CoV-2, prevalence, asymptomatic infection, spread dynamics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27,000 participants (actual)
- Lead sponsor
- Institute of Health Information and Statistics of the Czech RepublicOther government
- Collaborators
- Ministry of Health, Czech Republic, Palacky University, Masaryk University, University of Ostrava, Faculty of Military Health Sciences, University of Defence in Brno, Faculty of Health Studies, J. E. Purkyně University in Ústí nad Labem, Charles University, Czech Republic, Institute for Clinical and Experimental Medicine, General University Hospital, Prague, University Hospital Olomouc, Brno University Hospital, Krajská zdravotní, a.s., Ústí nad Labem Region Hospitals, Military University Hospital, Prague, Masaryk Memorial Cancer Institute, Czech Academy of Sciences, Czech Statistical Office
- Study start
- 23 Apr 2020 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 26 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Population area cohort - Control Cohort | – | Diagnostic Test: SARS-CoV-2 diagnostic rapid testA 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. |
| Population cohort from specific geographical areas | – | Diagnostic Test: SARS-CoV-2 diagnostic rapid test, Diagnostic Test: Quantitative analysis of SARS-CoV-2 antibodiesThis 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. |
| Chronically ill patients cohort | – | Diagnostic Test: SARS-CoV-2 diagnostic rapid testA cohort of chronically ill people enrolled by Institute for Clinical and Experimental Medicine with chronic cardiovascular problems, hypertension, or diabetes. |
Who may qualify
- Ages
- 8 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SARS-CoV-2 diagnostic rapid testThe 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 | Chronically ill patients cohort, Population area cohort - Control Cohort, Population cohort from specific geographical areas |
| Quantitative analysis of SARS-CoV-2 antibodiesThe 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). | Diagnostic test | Population cohort from specific geographical areas |
Primary outcome
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).
3 secondary outcomes
Estimation of the proportion of people with a subclinical course of the disease
Time frame: 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.
Time frame: May 2020
Estimation of the proportion of persons suitable for the donation of convalescent plasma
Time frame: May 2020
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2020.
- Individual participant dataSharing planned: Undecided. It is not yet known if there will be a plan to make IPD available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roman Chlíbek, Prof. study director
University of Defence in Brno
Rastislav Maďar, Assoc. Prof. study director
University of Ostrava, Faculy of Medicine
Marián Hajdúch, Assoc. Prof. study director
Institute of Molecular and Translational Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID and SARS-CoV 2, run by Institute of Health Information and Statistics of the Czech Republic at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimation of the actual prevalence of SARS-CoV-2 positive persons in the Czech Republic. (time frame: May 2020). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2020.