Antibody Detection in COVID-19 Cured Patients (SARS-CoV-2-CZ-Immunity)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Antibody Detection in COVID-19 Cured Patients (SARS-CoV-2-CZ-Immunity)

Conditions
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COVID, SARS-CoV-2

Intervention / Treatment
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* Diagnostic Test: Quantitative analysis of anti-SARS-CoV-2-antibodies
* Diagnostic Test: SARS-CoV-2 diagnostic rapid test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: signed Informed Consent residing in Prague, Central Bohemian Region or South Moravian Region demographic criteria: persons aged 8-17 and persons aged 18 and more clinical criteria: (i) diagnosis of COVID-19 confirmed by PCR (ii) cured patients: clearance of SARS-CoV-2 viral RNA demonstrated by two consecutive negative RT-PCR results (iii) without acute health problems

Ages Eligible for Study
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Minimum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1 - Prague and Central Bohemian Region<br>A population cohort of cured patients based on epidemiologically defined demographic parameters - Prague and Central Bohemian Region population | Diagnostic Test: Quantitative analysis of anti-SARS-CoV-2-antibodies<br>* Plasma sampling will be collected and archived for subsequent quantitative analysis of anti-SARS-CoV-2 antibodies - IgG, IgM and IgA.<br>Diagnostic Test: SARS-CoV-2 diagnostic rapid test<br>* The rapid test detects the presence of antibodies against SARS-CoV-2 by the immunochromatographic reaction.<br>|
| Cohort 2 - South Moravian Region<br>A population cohort of cured patients based on epidemiologically defined demographic parameters - South Moravian Region population. | Diagnostic Test: Quantitative analysis of anti-SARS-CoV-2-antibodies<br>* Plasma sampling will be collected and archived for subsequent quantitative analysis of anti-SARS-CoV-2 antibodies - IgG, IgM and IgA.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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antibody, humoral immunity, SARS-CoV-2