SARS-CoV-2, SARS-CoV-2 (COVID-19) Infection
Conditions
Keywords
SARS-CoV-2
Brief 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.
Interventions
PROCEDUREBlood sampling
Venous blood sampling three times on three visits of the study.
PROCEDUREGargle 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.
Patient will complete questionnaire on each visit on SARS-CoV-2 infections and vaccinations
DIAGNOSTIC_TESTBody temperature measurement
Body temperature will be measured by healthcare professional at each visit to exclude patients with acute infection.
Sponsors
The Institute of Molecular and Translational Medicine, Czech Republic
Palacky University
University Hospital Olomouc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of people in the population of the Olomouc Region with the presence of antibodies against the SARS-CoV-2 virus | 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
| Measure | Time frame | Description |
|---|---|---|
| Quantification of the level/presence of cellular immunity | 12 months | Quantification of the level/presence of cellular immunity will be done from venous blood. |
| Verification of the presence of the SARS-CoV-2 virus | 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 |
| Proportion of people with an asymptomatic course of SARS-CoV-2 disease | 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. |
| Quantification of the presence of antibodies and the presence of cellular immunity | 12 months | Quantification of the presence of antibodies and the presence of cellular immunity according to risk factors and time interval since infection/immunization |
Countries
Czechia
Contacts
STUDY_DIRECTORMarian Hajduch, MD, PhD
Palacky University Olomouc
Outcome results
None listed