Antibody Detection in COVID-19 Cured Patients (SARS-CoV-2-CZ-Immunity)
- Conditions
- COVIDSARS-CoV-2
- Interventions
- Diagnostic Test: Quantitative analysis of anti-SARS-CoV-2-antibodiesDiagnostic Test: SARS-CoV-2 diagnostic rapid test
- Registration Number
- NCT04453280
- Lead Sponsor
- Institute of Health Information and Statistics of the Czech Republic
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 695
- 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
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cohort 1 - Prague and Central Bohemian Region SARS-CoV-2 diagnostic rapid test A population cohort of cured patients based on epidemiologically defined demographic parameters - Prague and Central Bohemian Region population Cohort 2 - South Moravian Region Quantitative analysis of anti-SARS-CoV-2-antibodies A population cohort of cured patients based on epidemiologically defined demographic parameters - South Moravian Region population. Cohort 1 - Prague and Central Bohemian Region Quantitative analysis of anti-SARS-CoV-2-antibodies A population cohort of cured patients based on epidemiologically defined demographic parameters - Prague and Central Bohemian Region population
- Primary Outcome Measures
Name Time Method Determination of the concentration of anti-SARS-CoV-2 antibodies in relation to the categories of cured patients. May 2020 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.
- Secondary Outcome Measures
Name Time Method Determination of the concentration of anti-SARS-CoV-2 antibodies in relation to the age and to the severity of the disease. June 2020 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.
The quantification of the dependence of the change in the concentration of anti-SARS-CoV-2 antibodies. June 2020 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)
Trial Locations
- Locations (1)
Institute of Health Information and Statistics of the Czech Republic
🇨🇿Prague, Czechia