Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Ministry of Health, Czech Republic | OTHER_GOV |
| The National Institute of Public Health | UNKNOWN |
| The Institute of Molecular and Translational Medicine, Czech Republic | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm IKEM | Arm IKEM (Institute for Clinical and Experimental Medicine) is represented by two subcohorts:
|
| |
| 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). |
| |
| 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:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quantitative analysis of SARS-CoV-2 antibodies | Diagnostic Test | 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). |
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
The study population is composed of different cohorts of people. The first cohort, Arm IKEM, is chosen from a database of chronically ill patients and subjects involved in the sociological study of the Czech Academy of Sciences. The second cohort, Arm FTN, is chosen from healthcare workers of the Thomayer University Hospital. The third cohort, Arm Olomouc, is composed of volunteers who participated in the Study SARS-CoV-2-CZ-Preval in May 2020.
All subjects will be contacted by email, phone, or SMS.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Ladislav Dušek, Prof. | Institute of Health Information and Statistics of the Czech Republic | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Health Information and Statistics of the Czech Republic | Prague | 128 01 | Czechia |
It is not yet known if there will be a plan to make IPD available.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D007111 | Immunity, Cellular |
| ID | Term |
|---|---|
| D056704 | Adaptive Immunity |
| D007109 | Immunity |
| D055633 | Immune System Phenomena |
Not provided
Not provided
| University Hospital Olomouc |
| OTHER |
| Institute for Clinical and Experimental Medicine | OTHER_GOV |
| Thomayer University Hospital | OTHER |
| Czech Academy of Sciences | OTHER |
| Palacky University | OTHER |
Not provided
Not provided
Not provided
Blood plasma sampling will be archived in the biobank for subsequent analyses.
| Cellular immunity | Diagnostic Test | Quantification of the level of cellular immunity from venous blood collected in approximately 30% of examined individuals. |
|
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |