NCT04874740

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 30, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

April 30, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 6, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2022

Completed
Last Updated

December 7, 2022

Status Verified

December 1, 2022

Enrollment Period

1.5 years

First QC Date

April 30, 2021

Last Update Submit

December 6, 2022

Conditions

Keywords

COVID-19Seroepidemiologic StudiesKidney transplant

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Number od Participants with change of baseline of anti-SARS-COV-2 antibodies

    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.

    Between 18 January 2020 and 30 September 2022

Study Arms (1)

Kidney transplant recipients

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

Other: No intervention

Interventions

No intervention

Kidney transplant recipients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients after any kidney transplantation, monitored regularly in the nephrology clinic of the University Hospital Ostrava.

You may qualify if:

  • 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.

You may not qualify if:

  • disagreement with participation in the study and data analysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Ostrava

Ostrava, 70852, Czechia

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Jan Vaclavik, prof.,M.D.

    University Hospital Ostrava

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2021

First Posted

May 6, 2021

Study Start

April 30, 2021

Primary Completion

October 30, 2022

Study Completion

October 30, 2022

Last Updated

December 7, 2022

Record last verified: 2022-12

Locations