NCT04361448

Brief Summary

The performance of 3 different sampling methods (2 nasopharyngeal swabs, 1 oropharyngeal swab) for the detection of SARS-CoV-2 with real-time reverse transcriptase polymerase chain reaction will be compared.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable covid19

Timeline
Completed

Started Apr 2020

Shorter than P25 for not_applicable covid19

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

April 20, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

April 20, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 24, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

February 15, 2021

Status Verified

February 1, 2021

Enrollment Period

2 months

First QC Date

April 20, 2020

Last Update Submit

February 11, 2021

Conditions

Covid-19SARS-CoV-2DiagnosisPolymerase Chain Reaction

Outcome Measures

Primary Outcomes (1)

  • sensitivity

    sensitivity of each sampling method for the detection of SARS-CoV-2 by RT-PCR

    1 month

Study Arms (1)

Health Care Workers with Covid-19 symptoms

OTHER

3 samples (2 nasopharyngeasl swabs, 1 oropharyngeal swab) willl be taken from each volunteer

Other: samling of oropharynx and nasopharynx

Interventions

samling of oropharynx and nasopharynxOTHER

Three different swabs will be taken of each participant: 1 oropharyngeal swab and 2 nasopharyngeal swabs

Health Care Workers with Covid-19 symptoms

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • health care workers with symptoms suspicious for Covid-19

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jessa Hospital

Hasselt, 3500, Belgium

Location

MeSH Terms

Conditions

COVID-19Disease

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Reinoud Cartuyvels

    Jessa Hospital, Hasselt, Belgium

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Each participant get study number. Samples will be identified by the study number.
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Beside the regular sampling method of 1 nasopharyngeal swab, 2 extra swabs will be taken in each volunteer. Performance of the 3 methods for laboratory diagnosis by PCR of Covid-19 will be compared.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 20, 2020

First Posted

April 24, 2020

Study Start

April 20, 2020

Primary Completion

June 30, 2020

Study Completion

June 30, 2020

Last Updated

February 15, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)