CClinicalTrials.gg
CompletedNCT04453280SARSCoV2CZImunUpdated Jul 1, 2020

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

An observational study in COVID and SARS-CoV-2, sponsored by Institute of Health Information and Statistics of the Czech Republic. Completed at 1 site in Czechia. Open to participants aged 8 Years and older. Per ClinicalTrials.gov, last updated 2020-07-01.

Sponsored by Institute of Health Information and Statistics of the Czech Republic · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
695
Ages
8 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • COVID
  • SARS-CoV-2

Keywords

  • SARS-CoV-2
  • antibody
  • humoral immunity
03

In context

Lead sponsor

Institute of Health Information and Statistics of the Czech Republic is the lead sponsor of 14 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
8 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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.

Eligibility 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
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
695 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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: Quantitative analysis of anti-SARS-CoV-2-antibodies · Diagnostic Test: SARS-CoV-2 diagnostic rapid test

  • Cohort 2 - South Moravian Region

    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

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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: May 2020

Secondary outcomes

  1. 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.

    Time frame: June 2020

  2. 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)

    Time frame: June 2020

Other outcomes

  1. 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.

    Time frame: June2020

07

Study locations

1 site
  • Institute of Health Information and Statistics of the Czech Republic
    Prague, 128 01, Czechia
08

References and documents

Individual participant data

Plan to share: Undecided — It is not yet known if there will be a plan to make IPD available.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 1, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04453280
Lead sponsor
Institute of Health Information and Statistics of the Czech Republic
Collaborators
Ministry of Health, Czech Republic, Masaryk University, Institute for Clinical and Experimental Medicine, Brno University Hospital, St. Anne's University Hospital Brno, Czech Republic, Masaryk Memorial Cancer Institute, Regional Public Health Office of the South Moravian Region based in Brno, Czech Republic, Public Health Office of the Capital City of Prague, Czech Republic, Regional Public Health Office of the Central Bohemian Region based in Prague, Czech Republic
Responsible party
Sponsor
First posted
Jul 1, 2020
Start date
May 18, 2020
Primary completion
Jun 3, 2020
Completion
Jun 3, 2020
Last update
Jul 1, 2020

Study contacts

Roman Prymula, Prof.
principal investigator · Ministry of Health, Czech Republic
Jarmila Rážová, M.D., Ph.D.
principal investigator · Ministry of Health, Czech Republic
Ladislav Dušek, Prof.
principal investigator · Institute of Health Information and Statistics of the Czech Republic
Dalibor Valík, Prof.
principal investigator · Masaryk Memorial Cancer Institute

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion