Clinical trial NCT04453280: Antibody Detection in COVID-19 Cured Patients (SARS-CoV-2-CZ-Immunity)
Official title: Antibody Detection in COVID-19 Cured Patients (SARS-CoV-2-CZ-Immunity)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID
SARS-CoV-2
Keywords: SARS-CoV-2
antibody
humoral immunity
Lead sponsor: Institute of Health Information and Statistics of the Czech Republic
Sponsor class: OTHER_GOV
Collaborators: name: Ministry of Health, Czech Republic
name: Masaryk University
name: Institute for Clinical and Experimental Medicine
name: Brno University Hospital
name: St. Anne's University Hospital Brno, Czech Republic
name: Masaryk Memorial Cancer Institute
name: Regional Public Health Office of the South Moravian Region based in Brno, Czech Republic
name: Public Health Office of the Capital City of Prague, Czech Republic
name: Regional Public Health Office of the Central Bohemian Region based in Prague, Czech Republic
First posted: 2020-07-01
Enrollment: 695
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: Determination of the concentration of anti-SARS-CoV-2 antibodies in relation to the categories of cured patients.
timeFrame: May 2020
Secondary outcomes:
measure: Determination of the concentration of anti-SARS-CoV-2 antibodies in relation to the age and to the severity of the disease.
timeFrame: June 2020
measure: The quantification of the dependence of the change in the concentration of anti-SARS-CoV-2 antibodies.
timeFrame: June 2020
Other outcomes:
measure: The identification of potential donors of convalescent plasma.
timeFrame: June2020
Locations:
city: Prague
country: Czechia
facility: Institute of Health Information and Statistics of the Czech Republic
Study officials:
affiliation: Ministry of Health, Czech Republic
name: Roman Prymula, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Ministry of Health, Czech Republic
name: Jarmila Rážová, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute of Health Information and Statistics of the Czech Republic
name: Ladislav Dušek, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Masaryk Memorial Cancer Institute
name: Dalibor Valík, Prof.
role: PRINCIPAL_INVESTIGATOR
References: