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NCT Number: NCT07387211

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

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.

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Key information

Conditions

SARS-CoV-2 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections SARS-CoV-2 (COVID-19) Infection Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Olomouc

Olomouc, 77900, Czechia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

blood sampling

Procedure

Venous blood sampling three times on three visits of the study.

Gargle sampling

Procedure

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 completion

Other

Patient will complete questionnaire on each visit on SARS-CoV-2 infections and vaccinations

Body temperature measurement

Diagnostic Test

Body temperature will be measured by healthcare professional at each visit to exclude patients with acute infection.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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

  3. 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.

  4. 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

Sponsors and collaborators

Lead sponsor

The Institute of Molecular and Translational Medicine, Czech Republic

Other

Collaborators

  • Palacky University
  • University Hospital Olomouc

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 4, 2026
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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