NCT04880122

Brief Summary

This study aims to validate dried blood spots (DBS) for SARS-CoV-2 (Severe Acute Respiratory Syndrome 2) antibody detection in elderly individuals.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
440

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2020

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 5, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 10, 2021

Completed
Last Updated

May 10, 2021

Status Verified

May 1, 2021

Enrollment Period

2 months

First QC Date

May 5, 2021

Last Update Submit

May 6, 2021

Conditions

SARS-CoV-2 Acute Respiratory Disease

Keywords

serologydried blood spotelderlynursing home residentsCOVID-19antibodiesimmunoglobinsserosurveillancevaccinationenzyme-linked immunosorbent assay (ELISA)

Outcome Measures

Primary Outcomes (2)

  • Sensitivity and specificity of DBS for SARS-CoV-2 antibody detection

    Sensitivity and specificity analysis

    baseline (single timepoint)

  • Optimization of the cut-off for seropositivity.

    Optimization of the manufacturer recommended cut-off for seropositivity in DBS.

    baseline (single timepoint)

Study Arms (1)

Nursing home residents/staff members

EXPERIMENTAL

Matched venous blood/dried blood spots collection in a single arm.

Diagnostic Test: Dried blood spot and venous blood collection

Interventions

Dried blood spot and venous blood collectionDIAGNOSTIC_TEST

A paired venous blood and capillary blood sample (dried blood spot) were collected in every participant for validation purpose. Venous blood samples were analyzed using a chemiluminescent microparticle immunoassay ( the Architect i2000sr Plus system, Abbott), as a reference. Dried blood spots (EUROIMMUN, PerkinElmer Health Sciences Inc., Lübeck, Germany) or (Whatman™, GE Healthcare Sciences, Cardiff, UK) were analyzed by means of a SARS-CoV-2 IgG ELISA (EUROIMMUN, PerkinElmer Health Sciences Inc., Lübeck, Germany).

Nursing home residents/staff members

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • nursing home staff and residents

You may not qualify if:

  • Not applicable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghent University

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

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

Study Officials

  • Piet Cools

    University Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2021

First Posted

May 10, 2021

Study Start

August 1, 2020

Primary Completion

September 30, 2020

Study Completion

September 30, 2020

Last Updated

May 10, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)