COVIDSARSCoV2CZImunNCT04453280
Antibody Detection in COVID-19 Cured Patients (SARS-CoV-2-CZ-Immunity)
An observational study of COVID and SARS-CoV-2, run by Institute of Health Information and Statistics of the Czech Republic at 1 site in Czechia.
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. Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- COVID, SARS-CoV-2
- What is being tested?
- Quantitative analysis of anti-SARS-CoV-2-antibodies and SARS-CoV-2 diagnostic rapid test
- How many people
- 695 participants
- Where
- 1 siteCzechia
- Study dates
- 18 May 2020to 3 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Czechia1 site
Institute of Health Information and Statistics of the Czech Republic
Prague, 128 01
About this study
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.
Read the 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.
- Conditions
- COVID, SARS-CoV-2
- Being tested
- Quantitative analysis of anti-SARS-CoV-2-antibodies, SARS-CoV-2 diagnostic rapid test
- Keywords
- SARS-CoV-2, antibody, humoral immunity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantitative analysis of anti-SARS-CoV-2-antibodiesDiagnostic test
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 testDiagnostic test
The rapid test detects the presence of antibodies against SARS-CoV-2 by the immunochromatographic reaction.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Quantitative analysis of anti-SARS-CoV-2-antibodies; Diagnostic Test: SARS-CoV-2 diagnostic rapid test | |
| Cohort 2 - South Moravian Region | A population cohort of cured patients based on epidemiologically defined demographic parameters - South Moravian Region population. Receives: Diagnostic Test: Quantitative analysis of anti-SARS-CoV-2-antibodies |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 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)
Measured: June 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2020
- Study start18 May 2020
- Primary completion3 Jun 2020
- Study completion3 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVIDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 695 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Health Information and Statistics of the Czech Republic
- Sponsor type
- Other government
- Collaborators
- Ministry of Health, Czech Republic, 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
- Responsible party
- Sponsor
- Investigators
- Roman Prymula, Prof., Principal investigator, Ministry of Health, Czech RepublicJarmila Rážová, M.D., Ph.D., Principal investigator, Ministry of Health, Czech RepublicLadislav Dušek, Prof., Principal investigator, Institute of Health Information and Statistics of the Czech RepublicDalibor Valík, Prof., Principal investigator, Masaryk Memorial Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04453280
- Sponsor's protocol ID
- UZIS 2020/2
- Acronym
- SARSCoV2CZImun
- Status last verified
- Jun 2020
- First submitted
- 30 Jun 2020
- Last updated
- 1 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is not yet known if there will be a plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibody Detection in COVID-19 Cured Patients (SARS-CoV-2-CZ-Immunity)
- ClinicalTrials.gov ID
- NCT04453280
- Acronym / sponsor ID
- SARSCoV2CZImun / UZIS 2020/2
- Conditions
- COVID, SARS-CoV-2
- Keywords
- SARS-CoV-2, antibody, humoral immunity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 695 participants (actual)
- Lead sponsor
- Institute of Health Information and Statistics of the Czech RepublicOther government
- Collaborators
- Ministry of Health, Czech Republic, 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
- Study start
- 18 May 2020 (actual)
- Primary completion
- 3 Jun 2020 (actual)
- Study completion
- 3 Jun 2020 (actual)
- First posted
- 1 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 - Prague and Central Bohemian Region | – | Diagnostic Test: Quantitative analysis of anti-SARS-CoV-2-antibodies, Diagnostic Test: SARS-CoV-2 diagnostic rapid testA population cohort of cured patients based on epidemiologically defined demographic parameters - Prague and Central Bohemian Region population |
| Cohort 2 - South Moravian Region | – | Diagnostic Test: Quantitative analysis of anti-SARS-CoV-2-antibodiesA population cohort of cured patients based on epidemiologically defined demographic parameters - South Moravian Region population. |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quantitative analysis of anti-SARS-CoV-2-antibodiesPlasma sampling will be collected and archived for subsequent quantitative analysis of anti-SARS-CoV-2 antibodies - IgG, IgM and IgA. | Diagnostic test | Cohort 1 - Prague and Central Bohemian Region, Cohort 2 - South Moravian Region |
| SARS-CoV-2 diagnostic rapid testThe rapid test detects the presence of antibodies against SARS-CoV-2 by the immunochromatographic reaction. | Diagnostic test | Cohort 1 - Prague and Central Bohemian Region |
Primary outcome
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.
2 secondary outcomes
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 quantification of the dependence of the change in the concentration of anti-SARS-CoV-2 antibodies.
Time frame: June 2020
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2020.
- Individual participant dataSharing planned: Undecided. It is not yet known if there will be a plan to make IPD available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roman Prymula, Prof. principal investigator
Ministry of Health, Czech Republic
Jarmila Rážová, M.D., Ph.D. principal investigator
Ministry of Health, Czech Republic
Ladislav Dušek, Prof. principal investigator
Institute of Health Information and Statistics of the Czech Republic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID and SARS-CoV-2, run by Institute of Health Information and Statistics of the Czech Republic at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of the concentration of anti-SARS-CoV-2 antibodies in relation to the categories of cured patients. (time frame: May 2020). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2020.