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

Completed

• Conditions: Transplantation, Kidney; COVID-19 Pandemic
• Interventions: Other: No intervention

• Registration Number: NCT04874740
• Lead Sponsor: University Hospital Ostrava

Brief 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.

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 Timeline

• Study Start: 2021-04-30
• Study First Submitted: 2021-04-30
• Study First Submitted QC: 2021-04-30
• Study First Posted: 2021-05-06
• Primary Completion: 2022-10-30
• Study Completion: 2022-10-30
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-06
• Last Update Posted: 2022-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Kidney transplant recipients	No intervention	Collection of data from kidney transplant patients at regular outpatient check-ups.

Primary Outcome Measures

Name	Time	Method
Number of Participants with positive anti-SARS-CoV-2 antibodies (one or more)	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).

Secondary Outcome Measures

Name	Time	Method
Number od Participants with change of baseline of anti-SARS-COV-2 antibodies	From May 1, 2021 to September 30, 2022	Development of antibodies in the observed period during follow up.
Number of Participants with positive anti-SARS-COV-2 antibodies in groups divided by age, sex, blood type.	Between 18 January 2020 and 30 September 2022	Seroprevalence depending on age, sex, blood type, time of measurement, time since transplantation, residence, type of immunosuppression.

Trial Locations

Locations (1)

University Hospital Ostrava; 🇨🇿 Ostrava, Czechia