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Antibody Detection in COVID-19 Cured Patients (SARS-CoV-2-CZ-Immunity) (SARSCoV2CZImun)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04453280
Recruitment Status : Completed
First Posted : July 1, 2020
Last Update Posted : July 1, 2020
Sponsor:
Collaborators:
Ministry of Health, Czech Republic
Faculty of Medicine, 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
Information provided by (Responsible Party):
Institute of Health Information and Statistics of the Czech Republic

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.

Condition or disease Intervention/treatment
COVID SARS-CoV-2 Diagnostic Test: Quantitative analysis of anti-SARS-CoV-2-antibodies Diagnostic Test: SARS-CoV-2 diagnostic rapid test

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.

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Study Type : Observational
Actual Enrollment : 695 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Antibody Detection in COVID-19 Cured Patients (SARS-CoV-2-CZ-Immunity)
Actual Study Start Date : May 18, 2020
Actual Primary Completion Date : June 3, 2020
Actual Study Completion Date : June 3, 2020

Resource links provided by the National Library of Medicine


Group/Cohort 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: 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.

Diagnostic Test: SARS-CoV-2 diagnostic rapid 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.
Diagnostic Test: 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.




Primary Outcome Measures :
  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 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. [ 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 Outcome Measures:
  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.


Biospecimen Retention:   Samples Without DNA
Blood plasma sampling will be archived in the biobank for subsequent quantitative analyses.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   8 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04453280


Locations
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Czechia
Institute of Health Information and Statistics of the Czech Republic
Prague, Czechia, 128 01
Sponsors and Collaborators
Institute of Health Information and Statistics of the Czech Republic
Ministry of Health, Czech Republic
Faculty of Medicine, 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
Investigators
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Principal Investigator: Roman Prymula, Prof. Ministry of Health, Czech Republic
Principal Investigator: Jarmila Rážová, M.D., Ph.D. Ministry of Health, Czech Republic
Principal Investigator: Ladislav Dušek, Prof. Institute of Health Information and Statistics of the Czech Republic
Principal Investigator: Dalibor Valík, Prof. Masaryk Memorial Cancer Institute
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Responsible Party: Institute of Health Information and Statistics of the Czech Republic
ClinicalTrials.gov Identifier: NCT04453280    
Other Study ID Numbers: UZIS 2020/2
First Posted: July 1, 2020    Key Record Dates
Last Update Posted: July 1, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: It is not yet known if there will be a plan to make IPD available.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institute of Health Information and Statistics of the Czech Republic:
SARS-CoV-2
antibody
humoral immunity
Additional relevant MeSH terms:
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Antibodies
Immunologic Factors
Physiological Effects of Drugs