COVID-19 PandemicSECOVtxNCT04874740
Seroprevalence of the Anti-SARS-CoV-2 Antibodies (Causing COVID-19) in Kidney Transplant Recipients in Severely Affected Region
An observational study of COVID-19 Pandemic and Transplantation, Kidney, run by University Hospital Ostrava at 1 site in Czechia.
Trial summary
Goal of this study is to evaluate the seroprevalence of anti-SARS-CoV-2 antibodies in patients after kidney transplantation who are one of the risk groups for the severe course of the infection and map the progression of the virus throughout this specific part of population, which is also important for possible future… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Pandemic, Transplantation, Kidney
- How many people
- 300 participants
- Where
- 1 siteCzechia
- Study dates
- 30 Apr 2021to 30 Oct 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients after any kidney transplantation, monitored regularly in the nephrology clinic of the University Hospital Ostrava.
Who may be able to join
- Age ≥ 18
- Recipient of a transplanted kidney
- Planned visit to the outpatient nephrology clinic of University Hospital Ostrava, Czech Republic, between 1.5. and 30.7.2021 for enrolment
- Planned blood collection and available results of blood tests from planned inspections from 18.1.2021.
- Signed consent to the use of anonymous data for scientific purposes and publications.
Who cannot join
- disagreement with participation in the study and data analysis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Seroprevalence of the Anti-SARS-CoV-2 Antibodies in Kidney Transplant Recipients in Severely Affected Region
Goal of this study is to evaluate the seroprevalence of anti-SARS-CoV-2 antibodies in patients after kidney transplantation who are one of the risk groups for the severe course of the infection and map the progression of the virus throughout this specific part of population, which is also important for possible future epidemics. We will evaluate the seroprevalence of anti-SARS-CoV-2 antibodies according to age and gender. We will compare seroprevalence in all measured antibodies types and we will also assess the development of antibodies level in positive patients.
Read the detailed description
The Czech Republic (Central Europe region) is one of the most affected countries in the World by COVID 19 pandemic. By 1st of March 2021, the SARS-COV-2 virus infection was proven in the Czech Republic in 1 247 051 thousand people, which is 11.7% of the population (11 627 per 100 000, in the USA 8743/100 000, in the UK 6300/100 000, in the Germany 2879/100 000, France 5379/100 000). The rapidly increasing number of people infected in October 2020 have led to adoption of strict countrywide epidemic measures, which are still largely ongoing. During first 2 months of 2021 was still serious spread of the virus in population with increasing numbers of infected persons.
The SARS-CoV-2 virus can be detected in the body by several ways. The presence of the virus can be directly confirmed by RT-PCR or by determination of viral antigen from a swab from the nasopharynx, throat, direct examination of sputum or aspirate from bronchoscopy, or rectum. Indirect methods of virus detection include the determination of antibodies in the blood. Antibodies can target several structures of the virus: spike protein (S), envelope, membrane or nucleocapsid (NP). The S protein is composed of S1 and S2 subunit. The S1 subunit contains receptor-binding domain (RBD) which is necessary for interaction and entering human cells. In practice, IgG, IgM and IgA antibodies against RBD and NP are usually detected.2,3 With regard of serious development of the COVID 19 epidemic situation in the Czech Republic, we decided to do this prevalence study. Our goal is to evaluate the seroprevalence of anti-SARS-CoV-2 antibodies in patients after kidney transplantation which is also important for possible future epidemics.
- Conditions
- COVID-19 Pandemic, Transplantation, Kidney
- Being tested
- No intervention
- Keywords
- COVID-19, Seroepidemiologic Studies, Kidney transplant
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Kidney transplant recipients | Collection of data from kidney transplant patients at regular outpatient check-ups. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with positive anti-SARS-CoV-2 antibodies (one or more)
Seroprevalence of anti-SARS-Cov 2 antibodies - in how many patients is positive at least one of the measured antibodies against SARS-Cov-2 virus (IgA, IgM or IgG against RBD, IgG against nucleocapsid).
Measured: Between 18 January 2020 and 30 September 2022
Secondary outcomes (2)
Number od Participants with change of baseline of anti-SARS-COV-2 antibodies
Development of antibodies in the observed period during follow up.
Measured: From May 1, 2021 to September 30, 2022
Number of Participants with positive anti-SARS-COV-2 antibodies in groups divided by age, sex, blood type.
Seroprevalence depending on age, sex, blood type, time of measurement, time since transplantation, residence, type of immunosuppression.
Measured: Between 18 January 2020 and 30 September 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2021
- Study start30 Apr 2021
- Primary completion30 Oct 2022
- Study completion30 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 PandemicStudies 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
- Other
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Ostrava
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jan Vaclavik, prof.,M.D., Study chair, University Hospital Ostrava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04874740
- Sponsor's protocol ID
- 2/IK-FNO/2021
- Acronym
- SECOVtx
- Status last verified
- Dec 2022
- First submitted
- 30 Apr 2021
- Last updated
- 7 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seroprevalence of the Anti-SARS-CoV-2 Antibodies in Kidney Transplant Recipients in Severely Affected Region
- ClinicalTrials.gov ID
- NCT04874740
- Acronym / sponsor ID
- SECOVtx / 2/IK-FNO/2021
- Conditions
- COVID-19 Pandemic, Transplantation, Kidney
- Keywords
- COVID-19, Seroepidemiologic Studies, Kidney transplant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University Hospital OstravaUniversity, hospital or other
- Study start
- 30 Apr 2021 (actual)
- Primary completion
- 30 Oct 2022 (actual)
- Study completion
- 30 Oct 2022 (actual)
- First posted
- 6 May 2021 (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.
Goal of this study is to evaluate the seroprevalence of anti-SARS-CoV-2 antibodies in patients after kidney transplantation who are one of the risk groups for the severe course of the infection and map the progression of the virus throughout this specific part of population, which is also important for possible future epidemics. We will evaluate the seroprevalence of anti-SARS-CoV-2 antibodies according to age and gender. We will compare seroprevalence in all measured antibodies types and we will also assess the development of antibodies level in positive patients.
Detailed description
The Czech Republic (Central Europe region) is one of the most affected countries in the World by COVID 19 pandemic. By 1st of March 2021, the SARS-COV-2 virus infection was proven in the Czech Republic in 1 247 051 thousand people, which is 11.7% of the population (11 627 per 100 000, in the USA 8743/100 000, in the UK 6300/100 000, in the Germany 2879/100 000, France 5379/100 000). The rapidly increasing number of people infected in October 2020 have led to adoption of strict countrywide epidemic measures, which are still largely ongoing. During first 2 months of 2021 was still serious spread of the virus in population with increasing numbers of infected persons.
The SARS-CoV-2 virus can be detected in the body by several ways. The presence of the virus can be directly confirmed by RT-PCR or by determination of viral antigen from a swab from the nasopharynx, throat, direct examination of sputum or aspirate from bronchoscopy, or rectum. Indirect methods of virus detection include the determination of antibodies in the blood. Antibodies can target several structures of the virus: spike protein (S), envelope, membrane or nucleocapsid (NP). The S protein is composed of S1 and S2 subunit. The S1 subunit contains receptor-binding domain (RBD) which is necessary for interaction and entering human cells. In practice, IgG, IgM and IgA antibodies against RBD and NP are usually detected.2,3 With regard of serious development of the COVID 19 epidemic situation in the Czech Republic, we decided to do this prevalence study. Our goal is to evaluate the seroprevalence of anti-SARS-CoV-2 antibodies in patients after kidney transplantation which is also important for possible future epidemics.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Kidney transplant recipients | – | Other: No interventionCollection of data from kidney transplant patients at regular outpatient check-ups. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients after any kidney transplantation, monitored regularly in the nephrology clinic of the University Hospital Ostrava.
Key inclusion criteria (5 listed)
- Age ≥ 18
- Recipient of a transplanted kidney
- Planned visit to the outpatient nephrology clinic of University Hospital Ostrava, Czech Republic, between 1.5. and 30.7.2021 for enrolment
- Planned blood collection and available results of blood tests from planned inspections from 18.1.2021.
- Signed consent to the use of anonymous data for scientific purposes and publications.
Key exclusion criteria (1 listed)
- disagreement with participation in the study and data analysis
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 |
|---|---|---|
| No interventionNo intervention | Other | Kidney transplant recipients |
Primary outcome
Number of Participants with positive anti-SARS-CoV-2 antibodies (one or more)
Time frame: Between 18 January 2020 and 30 September 2022
Seroprevalence of anti-SARS-Cov 2 antibodies - in how many patients is positive at least one of the measured antibodies against SARS-Cov-2 virus (IgA, IgM or IgG against RBD, IgG against nucleocapsid).
2 secondary outcomes
Number od Participants with change of baseline of anti-SARS-COV-2 antibodies
Time frame: From May 1, 2021 to September 30, 2022
Number of Participants with positive anti-SARS-COV-2 antibodies in groups divided by age, sex, blood type.
Time frame: Between 18 January 2020 and 30 September 2022
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 7 Dec 2022.
- Individual participant dataSharing planned: Undecided
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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.
Jan Vaclavik, prof.,M.D. study chair
University Hospital Ostrava
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-19 Pandemic and Transplantation, Kidney, run by University Hospital Ostrava 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 5 inclusion and 1 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 7 Dec 2022. 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?
Number of Participants with positive anti-SARS-CoV-2 antibodies (one or more) (time frame: Between 18 January 2020 and 30 September 2022). 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 7 Dec 2022.