Seroprevalence of the Anti-SARS-CoV-2 Antibodies (Causing COVID-19) in Kidney Transplant Recipients in Severely Affected Region

COVID-19 Pandemic Clinical Trial

— SECOVtx  

Official title:

Seroprevalence of the Anti-SARS-CoV-2 Antibodies in Kidney Transplant Recipients in Severely Affected Region

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04874740
• Other study ID #: 2/IK-FNO/2021
• Status: Completed
• Start date: April 30, 2021
• Est. completion date: October 30, 2022

Study information

• Verified date: December 2022
• Source: University Hospital Ostrava
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: October 30, 2022
• Est. primary completion date: October 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• disagreement with participation in the study and data analysis

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Pandemic
• Transplantation, Kidney

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
Czechia	University Hospital Ostrava	Ostrava

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Ostrava

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Between 18 January 2020 and 30 September 2022
Secondary	Number od Participants with change of baseline of anti-SARS-COV-2 antibodies	Development of antibodies in the observed period during follow up.	From May 1, 2021 to September 30, 2022
Secondary	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.	Between 18 January 2020 and 30 September 2022