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

Sponsor

University Hospital Ostrava (Other)

Overall Status

Recruiting

CT.gov ID

NCT04874740

Collaborator

(none)

300

Enrollment

Location

Anticipated Duration (Months)

16.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19 Pandemic Transplantation, Kidney	Other: No intervention

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

Study Type:

Observational

Anticipated Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Other

Official Title:

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

Actual Study Start Date :

Apr 30, 2021

Anticipated Primary Completion Date :

Oct 30, 2022

Anticipated Study Completion Date :

Oct 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Kidney transplant recipients Collection of data from kidney transplant patients at regular outpatient check-ups.	Other: No intervention No intervention

Arm

Intervention/Treatment

Kidney transplant recipients

Collection of data from kidney transplant patients at regular outpatient check-ups.

Other: No intervention

No intervention

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Ostrava	Ostrava		Czechia	70852

Sponsors and Collaborators

University Hospital Ostrava

Investigators

Study Chair: Jan Vaclavik, prof.,M.D., University Hospital Ostrava

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital Ostrava

ClinicalTrials.gov Identifier:

NCT04874740

Other Study ID Numbers:

2/IK-FNO/2021

First Posted:

May 6, 2021

Last Update Posted:

May 10, 2021

Last Verified:

May 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University Hospital Ostrava

COVID-19

Seroepidemiologic Studies

Kidney transplant

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of May 10, 2021