Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04874740 |
Other study ID # |
2/IK-FNO/2021 |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
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 |
Health authority |
|
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.