Performance of 3 Sampling Methods for the Detection of SARS-CoV-2 (COVID-19) With Real-time Reverse Transcriptase PCR

NCT ID: NCT04361448

Last Updated: 2021-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-20

Study Completion Date

2020-06-30

Brief Summary

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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.

Detailed Description

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Thirty volunteers will be recruited from health care workers suspicious for Covid-19, who consult the ocupational physician for Covid-19 testing.

For each volunteer, 3 swabs will be taken:

* Flocked eSwab (Copan, Italy) of the oropharynx
* Flocked nasopharyngeal eSwab (Copan, Italy) of the nasopharynx
* Dry flocked nasopharyngeal Swab, placed in lysis buffer Each swab will be tested for the presence of SARS-CoV-2 with an in-house reverse-transcriptase real-time PCR (Egene).

Performance of each method will be calculated.

Conditions

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Covid-19 SARS-CoV-2 Diagnosis Polymerase Chain Reaction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Each participant get study number. Samples will be identified by the study number.

Study Groups

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Health Care Workers with Covid-19 symptoms

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

Group Type OTHER

samling of oropharynx and nasopharynx

Intervention Type OTHER

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

Interventions

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samling of oropharynx and nasopharynx

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* health care workers with symptoms suspicious for Covid-19

Exclusion Criteria

* none
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Jessa Hospital

OTHER

Sponsor Role lead

Responsible Party

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Reinoud Cartuyvels

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Reinoud Cartuyvels

Role: PRINCIPAL_INVESTIGATOR

Jessa Hospital, Hasselt, Belgium

Locations

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Jessa Hospital

Hasselt, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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20.43

Identifier Type: -

Identifier Source: org_study_id

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