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| Name | Class |
|---|---|
| Palacky University | OTHER |
| University Hospital Olomouc | OTHER |
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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants of the SARS-CoV-2-CZ-Preval study from the Olomouc region | Other | Population of persons involved in the SARS-CoV-2-CZ-Preval study in 2020 in the Olomouc region |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sampling | Procedure | Venous blood sampling three times on three visits of the study. |
|
| 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Quantification of the level/presence of cellular immunity | 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 |
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Inclusion Criteria:
Exclusion Criteria:
• Participant with acute health problems
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| Name | Affiliation | Role |
|---|---|---|
| Marian Hajduch, MD, PhD | Palacky University Olomouc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Olomouc | Olomouc | 77900 | Czechia |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D007239 | Infections |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D014777 | Virus Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| D001831 | Body Temperature |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| 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. |
|
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 | 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 | Quantification of the presence of antibodies and the presence of cellular immunity according to risk factors and time interval since infection/immunization | 12 months |
| D018352 |
| Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D055986 | Vital Signs |
| D010808 | Physical Examination |
| D010829 | Physiological Phenomena |