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
Brief Summary

The aim of the study is to find the proportion of people in the population of the OlomoucRegion with the presence of IgG (or IgM) antibodies against the S and N antigens of theSARS-CoV-2 virus, therefore people who have already encountered the SARS-CoV-2 virus withmanifest 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.

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

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.

Eligibility Criteria

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Czechia
Locations

University Hospital Olomouc
Olomouc, Czechia

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

The Institute of Molecular and Translational Medicine, Czech Republic
NCT Number
Keywords
SARS-CoV-2
MeSH Terms
COVID-19
Infections
Blood Specimen Collection
Body Temperature