SARS-CoV-2NCT07387211
Study SARS-CoV-2-CZ-PREVAL-II - Arm of the Olomouc Region
A study testing Blood sampling, Gargle sampling and Questionnaire completion in people with SARS-CoV-2 and SARS-CoV-2 (COVID-19) Infection, run by The Institute of Molecular and Translational Medicine, Czech Republic at 1 site in Czechia.
Trial summary
The aim of the study is to find the proportion of people in the population of the Olomouc Region with the presence of IgG (or IgM) antibodies against the S and N antigens of the SARS-CoV-2 virus, therefore people who have already encountered the SARS-CoV-2 virus with manifest antibody formation, or people who have… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV-2, SARS-CoV-2 (COVID-19) Infection
- What is being tested?
- Blood sampling, Gargle sampling and Questionnaire completion
- Type of treatment
- Vaccines, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,484 participants
- Where
- 1 siteCzechia
- Study dates
- 18 Jan 2022to 13 Oct 2022
- Phase
- Interventional
- 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
Who may be able to join
- Participation in the SARS-CoV-2-CZ-PREVAL study and venous blood examined as part of this study
- Signed study informed consent and consent to the processing of personal data
- Adults (age 18 and over)
- Willingness to complete the questionnaire
Who cannot join
- Participant with acute health problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study SARS-CoV-2-CZ-PREVAL-II - Arm of the Olomouc Region Study to Quantify the Presence of Antibodies and Cellular Immunity Against SARS-CoV-2 in the Population of Persons Participating in the SARS-CoV-2-CZ-PREVAL Study in 2020
The aim of the study is to find the proportion of people in the population of the Olomouc Region with the presence of IgG (or IgM) antibodies against the S and N antigens of the SARS-CoV-2 virus, therefore people who have already encountered the SARS-CoV-2 virus with manifest antibody formation, or people who have undergone vaccination against COVID-19.
Read the detailed description
Study has three study visits. First two visits are three months apart. Second and third visits are five months apart. On each study visit participant will provide venous blood sample and saliva sample obtained by gargling with the use of GARGTEST sampling kit. Participant will also fill in a questionnaire about SARS-CoV-2 infections and vaccinations. Site staff will measure the body temperature of the patient to exclude a patient with an acute infection. Blood sample will be used for the assessment of antibodies and cellular immunity of SARS-CoV-2. Part of the blood will be biobanked for the future SARS-CoV-2 biomarker determination. Gargling sample will be used for the demonstration of the pathogen on mucous membranes. Gargle self-sampling using GARGTEST sampling kit will be done by participants at 14-day intervals between the study visits. For gargle sample RT-PCR (real time polymerase chain reaction) will be done to determine the patogen presence.
- Conditions
- SARS-CoV-2, SARS-CoV-2 (COVID-19) Infection
- Being tested
- Blood sampling, Gargle sampling, Questionnaire completion, Body temperature measurement
- Keywords
- SARS-CoV-2
- Medical subject headings
- COVID-19, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingProcedure or surgery
Venous blood sampling three times on three visits of the study.
Gargle samplingProcedure or surgery
Gargle sampling using GARGTEST sampling kit on three visits of the study and also gargle self-sampling using GARGTEST sampling kit at 14-day intervals between the study visits.
Questionnaire completionOther
Patient will complete questionnaire on each visit on SARS-CoV-2 infections and vaccinations
Body temperature measurementDiagnostic test
Body temperature will be measured by healthcare professional at each visit to exclude patients with acute infection.
| Study group | Role | What they receive |
|---|---|---|
| Participants of the SARS-CoV-2-CZ-Preval study from the Olomouc region | Other | Population of persons involved in the SARS-CoV-2-CZ-Preval study in 2020 in the Olomouc region Receives: Procedure: Blood sampling; Procedure: Gargle sampling; Other: Questionnaire completion; Diagnostic Test: Body temperature measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of people in the population of the Olomouc Region with the presence of antibodies against the SARS-CoV-2 virus
The proportion of people in the population of the Olomouc Region with the presence of IgG (or IgM) antibodies against the S and N antigens of the SARS-CoV-2 virus, therefore people who have already encountered the SARS-CoV-2 virus with manifest antibody formation, or people who have undergone vaccination against COVID-19.
Measured: 12 months
Secondary outcomes (4)
Quantification of the level/presence of cellular immunity
Quantification of the level/presence of cellular immunity will be done from venous blood.
Measured: 12 months
Verification of the presence of the SARS-CoV-2 virus
Verification of the presence of the SARS-CoV-2 virus on the mucous membranes of the oral cavity and pharynx using a PCR (polymerase chain reaction) test
Measured: 12 months
Proportion of people with an asymptomatic course of SARS-CoV-2 disease
Proportion of people with an asymptomatic course of the disease - a combination of antibody tests, questionnaire surveys and data from the Institute of Health Information and Statistics of the Czech Republic will be used to assess this outcome.
Measured: 12 months
Quantification of the presence of antibodies and the presence of cellular immunity
Quantification of the presence of antibodies and the presence of cellular immunity according to risk factors and time interval since infection/immunization
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start18 Jan 2022
- Primary completion13 Oct 2022
- Study completion13 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,484 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Institute of Molecular and Translational Medicine, Czech Republic
- Sponsor type
- University, hospital or other
- Collaborators
- Palacky University, University Hospital Olomouc
- Responsible party
- Sponsor
- Investigators
- Marian Hajduch, MD, PhD, Study director, Palacky University Olomouc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07387211
- Sponsor's protocol ID
- 34909
- Status last verified
- Jan 2026
- First submitted
- 28 Jan 2026
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study SARS-CoV-2-CZ-PREVAL-II - Arm of the Olomouc Region Study to Quantify the Presence of Antibodies and Cellular Immunity Against SARS-CoV-2 in the Population of Persons Participating in the SARS-CoV-2-CZ-PREVAL Study in 2020
- ClinicalTrials.gov ID
- NCT07387211
- Acronym / sponsor ID
- 34909
- Conditions
- SARS-CoV-2, SARS-CoV-2 (COVID-19) Infection
- Keywords
- SARS-CoV-2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,484 participants (actual)
- Lead sponsor
- The Institute of Molecular and Translational Medicine, Czech RepublicUniversity, hospital or other
- Collaborators
- Palacky University, University Hospital Olomouc
- Study start
- 18 Jan 2022 (actual)
- Primary completion
- 13 Oct 2022 (actual)
- Study completion
- 13 Oct 2022 (actual)
- First posted
- 4 Feb 2026 (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 study is to find the proportion of people in the population of the Olomouc Region with the presence of IgG (or IgM) antibodies against the S and N antigens of the SARS-CoV-2 virus, therefore people who have already encountered the SARS-CoV-2 virus with manifest antibody formation, or people who have undergone vaccination against COVID-19.
Detailed description
Study has three study visits. First two visits are three months apart. Second and third visits are five months apart. On each study visit participant will provide venous blood sample and saliva sample obtained by gargling with the use of GARGTEST sampling kit. Participant will also fill in a questionnaire about SARS-CoV-2 infections and vaccinations. Site staff will measure the body temperature of the patient to exclude a patient with an acute infection. Blood sample will be used for the assessment of antibodies and cellular immunity of SARS-CoV-2. Part of the blood will be biobanked for the future SARS-CoV-2 biomarker determination. Gargling sample will be used for the demonstration of the pathogen on mucous membranes. Gargle self-sampling using GARGTEST sampling kit will be done by participants at 14-day intervals between the study visits. For gargle sample RT-PCR (real time polymerase chain reaction) will be done to determine the patogen presence.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants of the SARS-CoV-2-CZ-Preval study from the Olomouc region | Other | Procedure: Blood sampling, Procedure: Gargle sampling, Other: Questionnaire completion, Diagnostic Test: Body temperature measurementPopulation of persons involved in the SARS-CoV-2-CZ-Preval study in 2020 in the Olomouc region |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participation in the SARS-CoV-2-CZ-PREVAL study and venous blood examined as part of this study
- Signed study informed consent and consent to the processing of personal data
- Adults (age 18 and over)
- Willingness to complete the questionnaire
Key exclusion criteria (1 listed)
- Participant with acute health problems
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 |
|---|---|---|
| Blood samplingVenous blood sampling three times on three visits of the study. | Procedure or surgery | Participants of the SARS-CoV-2-CZ-Preval study from the Olomouc region |
| Gargle samplingGargle sampling using GARGTEST sampling kit on three visits of the study and also gargle self-sampling using GARGTEST sampling kit at 14-day intervals between the study visits. | Procedure or surgery | Participants of the SARS-CoV-2-CZ-Preval study from the Olomouc region |
| Questionnaire completionPatient will complete questionnaire on each visit on SARS-CoV-2 infections and vaccinations | Other | Participants of the SARS-CoV-2-CZ-Preval study from the Olomouc region |
| Body temperature measurementBody temperature will be measured by healthcare professional at each visit to exclude patients with acute infection. | Diagnostic test | Participants of the SARS-CoV-2-CZ-Preval study from the Olomouc region |
Primary outcome
The proportion of people in the population of the Olomouc Region with the presence of antibodies against the SARS-CoV-2 virus
Time frame: 12 months
The proportion of people in the population of the Olomouc Region with the presence of IgG (or IgM) antibodies against the S and N antigens of the SARS-CoV-2 virus, therefore people who have already encountered the SARS-CoV-2 virus with manifest antibody formation, or people who have undergone vaccination against COVID-19.
4 secondary outcomes
Quantification of the level/presence of cellular immunity
Time frame: 12 months
Verification of the presence of the SARS-CoV-2 virus
Time frame: 12 months
Proportion of people with an asymptomatic course of SARS-CoV-2 disease
Time frame: 12 months
Quantification of the presence of antibodies and the presence of cellular immunity
Time frame: 12 months
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 4 Feb 2026.
- Individual participant dataSharing planned: No
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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.
Marian Hajduch, MD, PhD study director
Palacky University Olomouc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sampling, Gargle sampling and Questionnaire completion in people with SARS-CoV-2 and SARS-CoV-2 (COVID-19) Infection, run by The Institute of Molecular and Translational Medicine, 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 4 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 4 Feb 2026. 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?
The proportion of people in the population of the Olomouc Region with the presence of antibodies against the SARS-CoV-2 virus (time frame: 12 months). 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 4 Feb 2026.