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Completed

NCT Number: NCT04453280

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

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.

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Key information

Conditions

COVID SARS-CoV-2

Age range

8 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institute of Health Information and Statistics of the Czech Republic

Prague, 128 01, Czechia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Diagnostic Test

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

SARS-CoV-2 diagnostic rapid test

Diagnostic Test

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

Primary outcomes

  1. Determination of the concentration of anti-SARS-CoV-2 antibodies in relation to the categories of cured patients.

    Time frame: 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 outcomes

  1. Determination of the concentration of anti-SARS-CoV-2 antibodies in relation to the age and to the severity of the disease.

    Time frame: 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.

  2. The quantification of the dependence of the change in the concentration of anti-SARS-CoV-2 antibodies.

    Time frame: 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 outcomes

  1. The identification of potential donors of convalescent plasma.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Institute of Health Information and Statistics of the Czech Republic

Other Gov

Collaborators

  • Brno University Hospital
  • Institute for Clinical and Experimental Medicine
  • Masaryk Memorial Cancer Institute
  • Masaryk University
  • Ministry of Health, 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
  • Regional Public Health Office of the South Moravian Region based in Brno, Czech Republic
  • St. Anne's University Hospital Brno, Czech Republic

Registry information

Acronym: SARSCoV2CZImun

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jul 1, 2020
Registry last updated
Jul 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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