Study SARS-CoV-2-CZ-PREVAL-II - Arm of the Olomouc Region

January 28, 2026 updated by: The Institute of Molecular and Translational Medicine, Czech Republic

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

2484

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Olomouc, Czechia, 77900
        • University Hospital Olomouc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

• Participant with acute health problems

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Participants of the SARS-CoV-2-CZ-Preval study from the Olomouc region
Population of persons involved in the SARS-CoV-2-CZ-Preval study in 2020 in the Olomouc region
Procedure: Blood sampling
Venous blood sampling three times on three visits of the study.
Procedure: Gargle sampling
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.
Other: Questionnaire completion
Patient will complete questionnaire on each visit on SARS-CoV-2 infections and vaccinations
Diagnostic test: Body temperature measurement
Body temperature will be measured by healthcare professional at each visit to exclude patients with acute infection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quantification of the level/presence of cellular immunity
Time Frame: 12 months
Quantification of the level/presence of cellular immunity will be done from venous blood.
12 months
Verification of the presence of the SARS-CoV-2 virus
Time Frame: 12 months
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
12 months
Proportion of people with an asymptomatic course of SARS-CoV-2 disease
Time Frame: 12 months
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.
12 months
Quantification of the presence of antibodies and the presence of cellular immunity
Time Frame: 12 months
Quantification of the presence of antibodies and the presence of cellular immunity according to risk factors and time interval since infection/immunization
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Institute of Molecular and Translational Medicine, Czech Republic

Collaborators

University Hospital Olomouc
Palacky University

Investigators

  • Study Director: Marian Hajduch, MD, PhD, Palacky University Olomouc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 18, 2022

Primary Completion (Actual)

October 13, 2022

Study Completion (Actual)

October 13, 2022

Study Registration Dates

First Submitted

January 28, 2026

First Submitted That Met QC Criteria

January 28, 2026

First Posted (Actual)

February 4, 2026

Study Record Updates

Last Update Posted (Actual)

February 4, 2026

Last Update Submitted That Met QC Criteria

January 28, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 34909

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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