NCT04378686

Brief Summary

Starting in late 2019, the world is facing a pandemic with the SARS-CoV-2 virus. Patients with end-stage kidney disease and on treatment with renal replacement therapy are high risk patients, as they are unable to maximize social distancing. We plan to gather epidemiological data using two different diagnostic approaches. We will compare a symptom-driven screening, in combination with a nasopharyngeal swab plus computed tomography (clinical approach) against serological surveillance.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Typical duration for all trials

Geographic Reach
1 country

3 active sites

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

Study Start

First participant enrolled

April 23, 2020

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

May 5, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 7, 2020

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2022

Completed
Last Updated

July 3, 2024

Status Verified

July 1, 2024

Enrollment Period

2.6 years

First QC Date

May 5, 2020

Last Update Submit

July 1, 2024

Conditions

SARS-CoV 2End Stage Renal Failure on Dialysis

Keywords

nasopharyngeal swabChest CTserology

Outcome Measures

Primary Outcomes (1)

  • Antibodies against SARS-CoV-2

    serology to test for IgG and IgM antibodies against SARS-CoV-2

    one year

Study Arms (1)

ESKD

Patients with ESKD and on treatment with any form of dialysis

Other: dialysis

Interventions

dialysisOTHER

treatment with dialysis. This can be hemodialysis, hemodiafiltration, peritoneal dialysis

ESKD

Eligibility Criteria

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

Patients with end-stage kidney disease (ESKD) receiving renal replacement therapy

You may qualify if:

  • Patients with end-stage kidney disease (ESKD) receiving renal replacement therapy
  • Age 18 years or older
  • Treated at University Hospitals Leuven, or Jessa Ziekenhuis Hasselt
  • Providing informed consent

You may not qualify if:

  • Refusal to provide informed consent
  • Transfer to another dialysis unit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Jessa Ziekenhuis

Hasselt, Limburg, 3500, Belgium

Location

Sint Trudo

Sint-Truiden, Limburg, 3800, Belgium

Location

University Hospitals Leuven

Leuven, 3000, Belgium

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Interventions

Dialysis

Intervention Hierarchy (Ancestors)

Chemistry Techniques, AnalyticalInvestigative TechniquesChemical Phenomena

Study Officials

  • Bjorn Meijers, MD, PhD

    UZ Leuven

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 5, 2020

First Posted

May 7, 2020

Study Start

April 23, 2020

Primary Completion

December 12, 2022

Study Completion

December 12, 2022

Last Updated

July 3, 2024

Record last verified: 2024-07

Locations

BE(3)