COVID-19: SARS-CoV-2-CZ-PREVAL-II Study
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
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:
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quantitative analysis of cellular immunity and the other relevant markers,
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estimation of the proportion of participants with asymptomatic COVID-19 infection
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quantification of anti-SARS-CoV-2 antibodies and cell immunity according to individual risk factors.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Arm IKEM 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
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).
Diagnostic Test: Cellular immunity
Quantification of the level of cellular immunity from venous blood collected in approximately 30% of examined individuals.
|
| Arm FTN 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
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).
Diagnostic Test: Cellular immunity
Quantification of the level of cellular immunity from venous blood collected in approximately 30% of examined individuals.
|
| Arm Olomouc 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
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).
Diagnostic Test: Cellular immunity
Quantification of the level of cellular immunity from venous blood collected in approximately 30% of examined individuals.
|
Outcome Measures
Primary Outcome Measures
- Detection of a number of subjects with IgG anti-SARS-CoV-2 antibodies [September-October 2021]
The primary outcome is to quantify the prevalence of participants with IgG anti-SARS-CoV-2 antibodies in the specified subjects cohorts.
Eligibility Criteria
Criteria
Inclusion Criteria:
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signed Informed consent
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willingness to complete the study questionnaire
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demographic criteria - age 18 years old and more
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clinical criteria - without acute health problems
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time criteria - sample collection in the defined period time
Exclusion Criteria:
- none
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Institute of Health Information and Statistics of the Czech Republic | Prague | Czechia | 128 01 |
Sponsors and Collaborators
- Institute of Health Information and Statistics of the Czech Republic
- Ministry of Health, Czech Republic
- The National Institute of Public Health
- The Institute of Molecular and Translational Medicine, Czech Republic
- University Hospital Olomouc
- Institute for Clinical and Experimental Medicine
- Thomayer University Hospital
- Czech Academy of Sciences
- Palacky University
Investigators
- Principal Investigator: Marián Hajdúch, Assoc. Prof., Institute of Molecular nad Translational Medicine
- Principal Investigator: Věra Adámková, Prof., Institute for Clinical and Experimental Medicine
- Principal Investigator: Markéta Ibrahimová, Ph.D., Thomayer University Hospital
- Principal Investigator: Barbora Macková, M.D., The National Institute of Public Health
- Study Director: Ladislav Dušek, Prof., Institute of Health Information and Statistics of the Czech Republic
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2021/2