Antibody Detection in COVID-19 Cured Patients (SARS-CoV-2-CZ-Immunity)
SARSCoV2CZImun
1 other identifier
observational
695
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 18, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 3, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 3, 2020
CompletedFirst Submitted
Initial submission to the registry
June 30, 2020
CompletedFirst Posted
Study publicly available on registry
July 1, 2020
CompletedJuly 1, 2020
June 1, 2020
16 days
June 30, 2020
June 30, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Determination of the concentration of anti-SARS-CoV-2 antibodies in relation to the age and 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.
June 2020
Other Outcomes (1)
The identification of potential donors of convalescent plasma.
June2020
Study Arms (2)
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
Cohort 2 - South Moravian Region
A population cohort of cured patients based on epidemiologically defined demographic parameters - South Moravian Region population.
Interventions
Plasma sampling will be collected and archived for subsequent quantitative analysis of anti-SARS-CoV-2 antibodies - IgG, IgM and IgA.
The rapid test detects the presence of antibodies against SARS-CoV-2 by the immunochromatographic reaction.
Eligibility Criteria
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.
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Institute of Health Information and Statistics of the Czech Republiclead
- Ministry of Health, Czech Republiccollaborator
- Masaryk Universitycollaborator
- Institute for Clinical and Experimental Medicinecollaborator
- Brno University Hospitalcollaborator
- St. Anne's University Hospital Brno, Czech Republiccollaborator
- Masaryk Memorial Cancer Institutecollaborator
- Regional Public Health Office of the South Moravian Region based in Brno, Czech Republiccollaborator
- Public Health Office of the Capital City of Prague, Czech Republiccollaborator
- Regional Public Health Office of the Central Bohemian Region based in Prague, Czech Republiccollaborator
Study Sites (1)
Institute of Health Information and Statistics of the Czech Republic
Prague, 128 01, Czechia
Biospecimen
Blood plasma sampling will be archived in the biobank for subsequent quantitative analyses.
Study Officials
- 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
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 30, 2020
First Posted
July 1, 2020
Study Start
May 18, 2020
Primary Completion
June 3, 2020
Study Completion
June 3, 2020
Last Updated
July 1, 2020
Record last verified: 2020-06