NCT07387211

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,484 (actual)
• Sponsor: The Institute of Molecular and Translational Medicine, Czech Republic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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 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.

Conditions

• SARS-CoV-2
• SARS-CoV-2 (COVID-19) Infection

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-01-18
• Primary completion: 2022-10-13
• Completion: 2022-10-13
• First posted: 2026-02-04
• Last updated: 2026-02-04

Locations

1 site across 1 country: Czechia