Self- Versus Conventional-swabbing for COVID-19 Screening (COVISWAB)

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-30

Study Completion Date

2021-12-31

Brief Summary

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Self-swabbing requires less personal protective equipment and could allow to test more people and even to do quick self-diagnosis if antigenic tests are available.

In a preliminary study on 190 medical students, the investigators have shown that self and conventional swabbing were identically well-accepted with equivalent level of pain and discomfort induced by swabbing. In a sub-group of this sample, the investigators have shown that the quality of the 2 sampling methods were equivalent.

The goal of this large study in the general population is to confirm these findings in an adequately powered study. Such results would allow to develop self-swabbing for large screening campaigns and eventually self-diagnosis using antigenic tests.

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Detailed Description

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All consecutive subjects coming to the 2 dedicated centers for COVID-19 screening in Clermont-Ferrand University hospital (one for medical students and one for the general population) will be asked to be included in the present study. They will be randomly assigned to either supervised self-swabbing followed by conventional swabbing led by a healthcare professional or the other way round.

All the subjects will have to complete a brief questionnaire including demographical characteristics (age, sex, height, weight, eye color), potential symptoms (asthenia, fever, anosmia…) anticipated pain and discomfort and previous nasopharyngeal swabbing experience. Pain, discomfort and overall acceptability of the procedure will be completed just after completion of the swabbing.

Conditions

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Covid19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized sequence of supervised self-swabbing and conventional swabbing for SARS-CoV-2 screening

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Supervised self-swabbing followed by conventional swabbing

the subjects will first benefit from a 5 minutes explanation on how to perform self-swabbing and will then performed the swabbing under the supervision of a trained healthcare professional

Group Type EXPERIMENTAL

nasopharyngeal swabbing procedure (self swabbing first)

Intervention Type OTHER

Patient realises the nasal swabbing himself first, then undergoes conventionnal swabbing

Conventional swabbing followed by supervised self-swabbing

the subject will undergo conventional nasopharyngeal swabbing performed by a trained healthcare professional first.

Group Type EXPERIMENTAL

nasopharyngeal swabbing procedure (conventionnal swabbing first)

Intervention Type OTHER

patient undergoes conventionnal swabbing first then realises the nasal swabbing himself

Interventions

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nasopharyngeal swabbing procedure (self swabbing first)

Patient realises the nasal swabbing himself first, then undergoes conventionnal swabbing

Intervention Type OTHER

nasopharyngeal swabbing procedure (conventionnal swabbing first)

patient undergoes conventionnal swabbing first then realises the nasal swabbing himself

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Any subject coming for nasopharyngeal swabbing for SARS-CoV-2 screening
* Fluent in French (both oral and written)
* Able to give an eclaired consent