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| Name | Class |
|---|---|
| Ministry of Health, Czech Republic | OTHER_GOV |
| Masaryk University | OTHER |
| Institute for Clinical and Experimental Medicine | OTHER_GOV |
| Brno University Hospital |
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The aim of the SARS-CoV-2-CZ-Immunity study is to determine the time profile of the presence of antibodies against SARS-CoV-2 in blood plasma by quantification of antibodies or performing a rapid test in COVID-19 cured patients.
COVID-19 is caused by a new type of coronavirus called SARS-CoV-2. It is a highly infectious disease, manifested mainly by fever, respiratory problems, muscle pain, and fatigue. However, despite the publication of hundreds of papers in the literature, fundamental information about the spread and course of the disease is still lacking in COVID-19. One of such key information is the time profile of the presence of antibodies against SARS-CoV-2 after the disease.
The SARS-CoV-2-CZ-Immunity study is aiming at the determination of the time profile of the presence of antibodies against SARS-CoV-2 in blood plasma by quantification of antibodies or performing a rapid test in COVID-19 cured patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 - Prague and Central Bohemian Region | A population cohort of cured patients based on epidemiologically defined demographic parameters - Prague and Central Bohemian Region population |
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| Cohort 2 - South Moravian Region | A population cohort of cured patients based on epidemiologically defined demographic parameters - South Moravian Region population. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quantitative analysis of anti-SARS-CoV-2-antibodies | Diagnostic Test | Plasma sampling will be collected and archived for subsequent quantitative analysis of anti-SARS-CoV-2 antibodies - IgG, IgM and IgA. |
| Measure | Description | Time Frame |
|---|---|---|
| Determination of the concentration of anti-SARS-CoV-2 antibodies in relation to the categories of cured patients. | The primary outcome is the determination of the concentration of anti-SARS-CoV-2 antibodies IgG, IgM, and IgA classes in relation to the categories of cured patients according to the time from the date of cure from the COVID-19 disease to the date of examination. | May 2020 |
| Measure | Description | Time Frame |
|---|---|---|
| Determination of the concentration of anti-SARS-CoV-2 antibodies in relation to the age and to the severity of the disease. | The determination of the concentration of anti-SARS-CoV-2 antibodies IgG, IgM, and IgA classes in relation to the categories of cured patients according to their age: category 8-17, 18-39, 40-59, 60 and more years and according to the severity of the disease. | June 2020 |
| Measure | Description | Time Frame |
|---|---|---|
| The identification of potential donors of convalescent plasma. | The identification of individuals in the study population, who can be contacted as voluntary donors of convalescent plasma, which is one of the therapeutic modalities in patients with severe COVID-19 disease. | June2020 |
Inclusion Criteria:
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Both cohorts will be selected from all actually cured individuals from specific demographic areas described in the cohorts. The cohorts of people will be addressed by Public Health Office.
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| Name | Affiliation | Role |
|---|---|---|
| Roman Prymula, Prof. | Ministry of Health, Czech Republic | Principal Investigator |
| Jarmila Rážová, M.D., Ph.D. | Ministry of Health, Czech Republic | Principal Investigator |
| Ladislav Dušek, Prof. | Institute of Health Information and Statistics of the Czech Republic | Principal Investigator |
| Dalibor Valík, Prof. | Masaryk Memorial Cancer Institute | Principal Investigator |
| 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.
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| OTHER |
| St. Anne's University Hospital Brno, Czech Republic | OTHER |
| Masaryk Memorial Cancer Institute | OTHER |
| Regional Public Health Office of the South Moravian Region based in Brno, Czech Republic | UNKNOWN |
| Public Health Office of the Capital City of Prague, Czech Republic | UNKNOWN |
| Regional Public Health Office of the Central Bohemian Region based in Prague, Czech Republic | UNKNOWN |
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Blood plasma sampling will be archived in the biobank for subsequent quantitative analyses.
| SARS-CoV-2 diagnostic rapid test | Diagnostic Test | The rapid test detects the presence of antibodies against SARS-CoV-2 by the immunochromatographic reaction. |
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| The quantification of the dependence of the change in the concentration of anti-SARS-CoV-2 antibodies. | The quantification of the dependence of the change in the concentration of anti-SARS-CoV-2 antibodies IgG, IgM, and IgA classes on the time since cure (analysis by statistical model) | June 2020 |