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

NCT ID: NCT04453280

Last Updated: 2020-07-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

695 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-18

Study Completion Date

2020-06-03

Brief Summary

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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

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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.

Conditions

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COVID SARS-CoV-2

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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

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

Intervention Type 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

Intervention Type DIAGNOSTIC_TEST

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.

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

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Quantitative 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.

Intervention Type DIAGNOSTIC_TEST

SARS-CoV-2 diagnostic rapid test

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health, Czech Republic

OTHER_GOV

Sponsor Role collaborator

Masaryk University

OTHER

Sponsor Role collaborator

Institute for Clinical and Experimental Medicine

OTHER_GOV

Sponsor Role collaborator

Brno University Hospital

OTHER

Sponsor Role collaborator

St. Anne's University Hospital Brno, Czech Republic

OTHER

Sponsor Role collaborator

Masaryk Memorial Cancer Institute

OTHER

Sponsor Role collaborator

Regional Public Health Office of the South Moravian Region based in Brno, Czech Republic

UNKNOWN

Sponsor Role collaborator

Public Health Office of the Capital City of Prague, Czech Republic

UNKNOWN

Sponsor Role collaborator

Regional Public Health Office of the Central Bohemian Region based in Prague, Czech Republic

UNKNOWN

Sponsor Role collaborator

Institute of Health Information and Statistics of the Czech Republic

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Roman Prymula, Prof.

Role: PRINCIPAL_INVESTIGATOR

Ministry of Health, Czech Republic

Jarmila Rážová, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Ministry of Health, Czech Republic

Ladislav Dušek, Prof.

Role: PRINCIPAL_INVESTIGATOR

Institute of Health Information and Statistics of the Czech Republic

Dalibor Valík, Prof.

Role: PRINCIPAL_INVESTIGATOR

Masaryk Memorial Cancer Institute

Locations

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Institute of Health Information and Statistics of the Czech Republic

Prague, , Czechia

Site Status

Countries

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Czechia

Other Identifiers

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UZIS 2020/2

Identifier Type: -

Identifier Source: org_study_id

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