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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04453280

Acronym

SARSCoV2CZImun

Enrollment

695

Registered

2020-07-01

Start date

2020-05-18

Completion date

2020-06-03

Last updated

2020-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID, SARS-CoV-2

Keywords

SARS-CoV-2, antibody, humoral immunity

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.

Interventions

DIAGNOSTIC_TESTQuantitative analysis of anti-SARS-CoV-2-antibodies

Plasma sampling will be collected and archived for subsequent quantitative analysis of anti-SARS-CoV-2 antibodies - IgG, IgM and IgA.

DIAGNOSTIC_TESTSARS-CoV-2 diagnostic rapid test

The rapid test detects the presence of antibodies against SARS-CoV-2 by the immunochromatographic reaction.

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

8 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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)

Other

Measure	Time frame	Description
The identification of potential donors of convalescent plasma.	June2020	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.

Countries

Czechia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026