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

University Hospital, Clermont-Ferrand

Status: Unknown

Conditions: Covid19

Treatments: Other: nasopharyngeal swabbing procedure (conventionnal swabbing first); Other: nasopharyngeal swabbing procedure (self swabbing first)

Study type: Interventional

Funder types: Other

Identifiers

NCT04831853

RBHP 2020 MOISSET 2

2020-A02913-36 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Exclusion criteria

• Contra-indication to nasopharyngeal swabbing
• Refusal to participate
• Pregnant women

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

Supervised self-swabbing followed by conventional swabbing

Experimental group

Description:

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

Treatment:

Other: nasopharyngeal swabbing procedure (self swabbing first)

Conventional swabbing followed by supervised self-swabbing

Experimental group

Description:

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

Treatment:

Other: nasopharyngeal swabbing procedure (conventionnal swabbing first)