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

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.

Study Overview

• Status: Completed
• Conditions: COVID; SARS-CoV-2
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 695

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	May 2020

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	June 2020
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)	June 2020

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	June2020

Collaborators and Investigators

• Sponsor: Institute of Health Information and Statistics of the Czech Republic
• Collaborators: Institute for Clinical and Experimental Medicine; Brno University Hospital; Masaryk University; St. Anne's University Hospital Brno, Czech Republic; Masaryk Memorial Cancer Institute; Ministry of Health, Czech Republic; 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: 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

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 18, 2020
• Primary Completion (ACTUAL): June 3, 2020
• Study Completion (ACTUAL): June 3, 2020

Study Registration Dates

• First Submitted: June 30, 2020
• First Submitted That Met QC Criteria: June 30, 2020
• First Posted (ACTUAL): July 1, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 1, 2020
• Last Update Submitted That Met QC Criteria: June 30, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: SARS-CoV-2; antibody; humoral immunity
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunologic Factors; Antibodies
• Other Study ID Numbers: UZIS 2020/2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: It is not yet known if there will be a plan to make IPD available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No