COVID-19NCT05096962
COVID-19: SARS-CoV-2-CZ-PREVAL-II Study
An observational study of COVID-19 and SARS-CoV-2 Infection, 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-II Study is to quantify the prevalence of participants with antibodies against SARS-CoV-2 and/or cell immunity against SARS-CoV-2 in specific subjects cohorts. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19, SARS-CoV-2 Infection
- What is being tested?
- Quantitative analysis of SARS-CoV-2 antibodies and Cellular immunity
- How many people
- 7,268 participants
- Where
- 1 siteCzechia
- Study dates
- 13 Sep 2021to 24 Feb 2022
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population is composed of different cohorts of people. The first cohort, Arm IKEM, is chosen from a database of chronically ill patients and subjects involved in the sociological study of the Czech Academy of Sciences. The second cohort, Arm FTN, is chosen from healthcare workers of the Thomayer University Hospital. The third cohort, Arm Olomouc, is composed of volunteers who participated in the Study SARS-CoV-2-CZ-Preval in May 2020. All subjects will be contacted by email, phone, or SMS.
Who may be able to join
- signed Informed consent
- willingness to complete the study questionnaire
- demographic criteria - age 18 years old and more
- clinical criteria - without acute health problems
- time criteria - sample collection in the defined period time
Who cannot join
- none
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: SARS-CoV-2-CZ-PREVAL-II Study
The aim of the SARS-CoV-2-CZ-PREVAL-II Study is to quantify the prevalence of participants with antibodies against SARS-CoV-2 and/or cell immunity against SARS-CoV-2 in specific subjects cohorts.
Read the detailed description
The aim of the SARS-CoV-2-CZ-PREVAL-II Study is to quantify the prevalence of participants with antibodies against SARS-CoV-2 and/or cell immunity against SARS-CoV-2 in four specific cohorts: participants with chronic illness, healthy volunteers participating in the Study of the Czech Academy of Science, healthcare workers, and healthy volunteers that participated in the "Herd Immunity Study SARS-CoV-2-CZ-Preval" in May 2020.
The primary aim of the study is to estimate the number of people with anti-SARS-CoV-2-antibodies, i.e., people with COVID-19 history, or with vaccination against COVID-19.
Antibodies test will focus on two main proteins of virus SARS-CoV-2: S-protein and N-protein.
The secondary aims of the study are:
- quantitative analysis of cellular immunity and the other relevant markers,
- estimation of the proportion of participants with asymptomatic COVID-19 infection
- quantification of anti-SARS-CoV-2 antibodies and cell immunity according to individual risk factors.
- Conditions
- COVID-19, SARS-CoV-2 Infection
- Being tested
- Quantitative analysis of SARS-CoV-2 antibodies, Cellular immunity
- Keywords
- antibodies, cell immunity
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantitative analysis of SARS-CoV-2 antibodiesDiagnostic test
The study will evaluate the current presence of infection, specific antibodies at least in the IgG class in blood plasma or serum (antibody tests focusing on two SARS-CoV-2 proteins: S-protein and N-protein).
Cellular immunityDiagnostic test
Quantification of the level of cellular immunity from venous blood collected in approximately 30% of examined individuals.
| Study group | Role | What they receive |
|---|---|---|
| Arm IKEM | Arm IKEM (Institute for Clinical and Experimental Medicine) is represented by two subcohorts:
* participants with chronic illness (adults only), which are part of the research project of the Institute of Clinical and Experimental Medicine (the expected number of participants in the study - 3 000)
* healthy subjects from the Study of Czech Academy of Science, who are following up in the Institute of Clinical and Experimental Medicine (the expected number of subjects in the study - 2000) The subjects will be contacted based on the Hospital study database. Receives: Diagnostic Test: Quantitative analysis of SARS-CoV-2 antibodies; Diagnostic Test: Cellular immunity | |
| Arm FTN | Arm FTN (Thomayer University Hospital) is represented by the healthcare staff of the Hospital (the expected number of subjects in the study - 1800). Receives: Diagnostic Test: Quantitative analysis of SARS-CoV-2 antibodies; Diagnostic Test: Cellular immunity | |
| Arm Olomouc | Arm Olomouc is represented by participants, who participated in the Study "Herd Immunity Study SARS-CoV-2-CZ-Preval" in May 2020 and at the same time subjects who will be willing to participate in this study. The involvement of subjects from two localities is expected:
* Olomouc
* Litovel, Uničov and Červenka. The expected number of subjects in the study is approximately 2500. Receives: Diagnostic Test: Quantitative analysis of SARS-CoV-2 antibodies; Diagnostic Test: Cellular immunity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of a number of subjects with IgG anti-SARS-CoV-2 antibodies
The primary outcome is to quantify the prevalence of participants with IgG anti-SARS-CoV-2 antibodies in the specified subjects cohorts.
Measured: September-October 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2021
- Study start13 Sep 2021
- Primary completion31 Oct 2021
- Study completion24 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- Prospective
- Enrolment
- 7,268 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, The National Institute of Public Health, The Institute of Molecular and Translational Medicine, Czech Republic, University Hospital Olomouc, Institute for Clinical and Experimental Medicine, Thomayer University Hospital, Czech Academy of Sciences, Palacky University
- Responsible party
- Sponsor
- Investigators
- Marián Hajdúch, Assoc. Prof., Principal investigator, Institute of Molecular nad Translational MedicineVěra Adámková, Prof., Principal investigator, Institute for Clinical and Experimental MedicineMarkéta Ibrahimová, Ph.D., Principal investigator, Thomayer University HospitalBarbora Macková, M.D., Principal investigator, The National Institute of Public HealthLadislav Dušek, Prof., Study director, Institute of Health Information and Statistics of the Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05096962
- Sponsor's protocol ID
- 2021/2
- Status last verified
- Oct 2021
- First submitted
- 22 Oct 2021
- Last updated
- 28 Nov 2022
- Results posted
- No
- Data monitoring committee
- 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 28 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SARS-CoV-2-CZ-PREVAL-II Study
- ClinicalTrials.gov ID
- NCT05096962
- Acronym / sponsor ID
- 2021/2
- Conditions
- COVID-19, SARS-CoV-2 Infection
- Keywords
- antibodies, cell immunity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,268 participants (actual)
- Lead sponsor
- Institute of Health Information and Statistics of the Czech RepublicOther government
- Collaborators
- Ministry of Health, Czech Republic, The National Institute of Public Health, The Institute of Molecular and Translational Medicine, Czech Republic, University Hospital Olomouc, Institute for Clinical and Experimental Medicine, Thomayer University Hospital, Czech Academy of Sciences, Palacky University
- Study start
- 13 Sep 2021 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 24 Feb 2022 (actual)
- First posted
- 27 Oct 2021 (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-II Study is to quantify the prevalence of participants with antibodies against SARS-CoV-2 and/or cell immunity against SARS-CoV-2 in specific subjects cohorts.
Detailed description
The aim of the SARS-CoV-2-CZ-PREVAL-II Study is to quantify the prevalence of participants with antibodies against SARS-CoV-2 and/or cell immunity against SARS-CoV-2 in four specific cohorts: participants with chronic illness, healthy volunteers participating in the Study of the Czech Academy of Science, healthcare workers, and healthy volunteers that participated in the "Herd Immunity Study SARS-CoV-2-CZ-Preval" in May 2020.
The primary aim of the study is to estimate the number of people with anti-SARS-CoV-2-antibodies, i.e., people with COVID-19 history, or with vaccination against COVID-19.
Antibodies test will focus on two main proteins of virus SARS-CoV-2: S-protein and N-protein.
The secondary aims of the study are:
- quantitative analysis of cellular immunity and the other relevant markers,
- estimation of the proportion of participants with asymptomatic COVID-19 infection
- quantification of anti-SARS-CoV-2 antibodies and cell immunity according to individual risk factors.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm IKEM | – | Diagnostic Test: Quantitative analysis of SARS-CoV-2 antibodies, Diagnostic Test: Cellular immunityArm IKEM (Institute for Clinical and Experimental Medicine) is represented by two subcohorts: * participants with chronic illness (adults only), which are part of the research project of the Institute of Clinical and Experimental Medicine (the expected number of participants in the study - 3 000) * healthy subjects from the Study of Czech Academy of Science, who are following up in the Institute of Clinical and Experimental Medicine (the expected number of subjects in the study - 2000) The subjects will be contacted based on the Hospital study database. |
| Arm FTN | – | Diagnostic Test: Quantitative analysis of SARS-CoV-2 antibodies, Diagnostic Test: Cellular immunityArm FTN (Thomayer University Hospital) is represented by the healthcare staff of the Hospital (the expected number of subjects in the study - 1800). |
| Arm Olomouc | – | Diagnostic Test: Quantitative analysis of SARS-CoV-2 antibodies, Diagnostic Test: Cellular immunityArm Olomouc is represented by participants, who participated in the Study "Herd Immunity Study SARS-CoV-2-CZ-Preval" in May 2020 and at the same time subjects who will be willing to participate in this study. The involvement of subjects from two localities is expected: * Olomouc * Litovel, Uničov and Červenka. The expected number of subjects in the study is approximately 2500. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population is composed of different cohorts of people. The first cohort, Arm IKEM, is chosen from a database of chronically ill patients and subjects involved in the sociological study of the Czech Academy of Sciences. The second cohort, Arm FTN, is chosen from healthcare workers of the Thomayer University Hospital. The third cohort, Arm Olomouc, is composed of volunteers who participated in the Study SARS-CoV-2-CZ-Preval in May 2020. All subjects will be contacted by email, phone, or SMS.
Key inclusion criteria (5 listed)
- signed Informed consent
- willingness to complete the study questionnaire
- demographic criteria - age 18 years old and more
- clinical criteria - without acute health problems
- time criteria - sample collection in the defined period time
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Quantitative analysis of SARS-CoV-2 antibodiesThe study will evaluate the current presence of infection, specific antibodies at least in the IgG class in blood plasma or serum (antibody tests focusing on two SARS-CoV-2 proteins: S-protein and N-protein). | Diagnostic test | Arm FTN, Arm IKEM, Arm Olomouc |
| Cellular immunityQuantification of the level of cellular immunity from venous blood collected in approximately 30% of examined individuals. | Diagnostic test | Arm FTN, Arm IKEM, Arm Olomouc |
Primary outcome
Detection of a number of subjects with IgG anti-SARS-CoV-2 antibodies
Time frame: September-October 2021
The primary outcome is to quantify the prevalence of participants with IgG anti-SARS-CoV-2 antibodies in the specified subjects cohorts.
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 28 Nov 2022.
- 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.
Marián Hajdúch, Assoc. Prof. principal investigator
Institute of Molecular nad Translational Medicine
Věra Adámková, Prof. principal investigator
Institute for Clinical and Experimental Medicine
Markéta Ibrahimová, Ph.D. principal investigator
Thomayer University Hospital
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-19 and SARS-CoV-2 Infection, 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 1 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 28 Nov 2022. 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?
Detection of a number of subjects with IgG anti-SARS-CoV-2 antibodies (time frame: September-October 2021). 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 28 Nov 2022.