Antibody Detection in COVID-19 Cured Patients (SARS-CoV-2-CZ-Immunity)
Keywords
Abstract
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.
Dates
| Last Verified: | 05/31/2020 |
| First Submitted: | 06/29/2020 |
| Estimated Enrollment Submitted: | 06/29/2020 |
| First Posted: | 06/30/2020 |
| Last Update Submitted: | 06/29/2020 |
| Last Update Posted: | 06/30/2020 |
| Actual Study Start Date: | 05/17/2020 |
| Estimated Primary Completion Date: | 06/02/2020 |
| Estimated Study Completion Date: | 06/02/2020 |
Condition or disease
Intervention/treatment
Diagnostic Test: Quantitative analysis of anti-SARS-CoV-2-antibodies
Diagnostic Test: Cohort 1 - Prague and Central Bohemian Region
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| 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 | Diagnostic Test: Cohort 1 - Prague and Central Bohemian Region The rapid test detects the presence of antibodies against SARS-CoV-2 by the immunochromatographic reaction. |
| Cohort 2 - South Moravian Region A population cohort of cured patients based on epidemiologically defined demographic parameters - South Moravian Region population. |
Eligibility Criteria
| Ages Eligible for Study | 8 Years To 8 Years |
| Sexes Eligible for Study | All |
| Sampling method | Non-Probability Sample |
| Accepts Healthy Volunteers | Yes |
| Criteria | 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 |
Outcome
Primary Outcome Measures
1. Determination of the concentration of anti-SARS-CoV-2 antibodies in relation to the categories of cured patients. [May 2020]
Secondary Outcome Measures
1. Determination of the concentration of anti-SARS-CoV-2 antibodies in relation to the age and to the severity of the disease. [June 2020]
2. The quantification of the dependence of the change in the concentration of anti-SARS-CoV-2 antibodies. [June 2020]
Other Outcome Measures
1. The identification of potential donors of convalescent plasma. [June2020]
