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

COVID Clinical Trial

— SARSCoV2CZImun  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04453280
• Other study ID #: UZIS 2020/2
• Status: Completed
• Start date: May 18, 2020
• Est. completion date: June 3, 2020

Study information

• Verified date: June 2020
• Source: Institute of Health Information and Statistics of the Czech Republic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 695
• Est. completion date: June 3, 2020
• Est. primary completion date: June 3, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID
• SARS-CoV-2

Intervention

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

Locations

Country	Name	City	State
Czechia	Institute of Health Information and Statistics of the Czech Republic	Prague

Sponsors (10)

Lead Sponsor

Collaborator

Institute of Health Information and Statistics of the Czech Republic

Brno University Hospital, Faculty of Medicine, Masaryk University, Institute for Clinical and Experimental Medicine, Masaryk Memorial Cancer Institute, 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

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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
Secondary	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