COVID-19: SARS-CoV-2-CZ-PREVAL-II Study

Study Overview
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Brief Summary
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The aim of the SARS-CoV-2-CZ-PREVAL-II Study is to quantify the prevalence of participants with antibodies against SARS-CoV-2 and/or cell immunity against SARS-CoV-2 in specific subjects cohorts.

Detailed Description
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The aim of the SARS-CoV-2-CZ-PREVAL-II Study is to quantify the prevalence of participants with antibodies against SARS-CoV-2 and/or cell immunity against SARS-CoV-2 in four specific cohorts: participants with chronic illness, healthy volunteers participating in the Study of the Czech Academy of Science, healthcare workers, and healthy volunteers that participated in the Herd Immunity Study SARS-CoV-2-CZ-Preval in May 2020. The primary aim of the study is to estimate the number of people with anti-SARS-CoV-2-antibodies, i.e., people with COVID-19 history, or with vaccination against COVID-19. Antibodies test will focus on two main proteins of virus SARS-CoV-2: S-protein and N-protein. The secondary aims of the study are: quantitative analysis of cellular immunity and the other relevant markers, estimation of the proportion of participants with asymptomatic COVID-19 infection quantification of anti-SARS-CoV-2 antibodies and cell immunity according to individual risk factors.

Official Title
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SARS-CoV-2-CZ-PREVAL-II Study

Conditions
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COVID-19, SARS-CoV-2 Infection

Intervention / Treatment
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* Diagnostic Test: Quantitative analysis of SARS-CoV-2 antibodies
* Diagnostic Test: Cellular immunity


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: signed Informed consent willingness to complete the study questionnaire demographic criteria - age 18 years old and more clinical criteria - without acute health problems time criteria - sample collection in the defined period time Exclusion Criteria: none

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Arm IKEM<br>Arm IKEM (Institute for Clinical and Experimental Medicine) is represented by two subcohorts: participants with chronic illness (adults only), which are part of the research project of the Institute of Clinical and Experimental Medicine (the expected number of participants in the study - 3 000) healthy subjects from the Study of Czech Academy of Science, who are following up in the Institute of Clinical and Experimental Medicine (the expected number of subjects in the study - 2000) The subjects will be contacted based on the Hospital study database. | Diagnostic Test: Quantitative analysis of SARS-CoV-2 antibodies<br>* The study will evaluate the current presence of infection, specific antibodies at least in the IgG class in blood plasma or serum (antibody tests focusing on two SARS-CoV-2 proteins: S-protein and N-protein).<br>Diagnostic Test: Cellular immunity<br>* Quantification of the level of cellular immunity from venous blood collected in approximately 30% of examined individuals.<br>|
| Arm FTN<br>Arm FTN (Thomayer University Hospital) is represented by the healthcare staff of the Hospital (the expected number of subjects in the study - 1800). | Diagnostic Test: Quantitative analysis of SARS-CoV-2 antibodies<br>* The study will evaluate the current presence of infection, specific antibodies at least in the IgG class in blood plasma or serum (antibody tests focusing on two SARS-CoV-2 proteins: S-protein and N-protein).<br>Diagnostic Test: Cellular immunity<br>* Quantification of the level of cellular immunity from venous blood collected in approximately 30% of examined individuals.<br>|
| Arm Olomouc<br>Arm Olomouc is represented by participants, who participated in the Study Herd Immunity Study SARS-CoV-2-CZ-Preval in May 2020 and at the same time subjects who will be willing to participate in this study. The involvement of subjects from two localities is expected: Olomouc Litovel, Uničov and Červenka. The expected number of subjects in the study is approximately 2500. | Diagnostic Test: Quantitative analysis of SARS-CoV-2 antibodies<br>* The study will evaluate the current presence of infection, specific antibodies at least in the IgG class in blood plasma or serum (antibody tests focusing on two SARS-CoV-2 proteins: S-protein and N-protein).<br>Diagnostic Test: Cellular immunity<br>* Quantification of the level of cellular immunity from venous blood collected in approximately 30% of examined individuals.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of a number of subjects with IgG anti-SARS-CoV-2 antibodies | The primary outcome is to quantify the prevalence of participants with IgG anti-SARS-CoV-2 antibodies in the specified subjects cohorts. | September-October 2021 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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antibodies, cell immunity