Clinical trial NCT04831853: Self- Versus Conventional-swabbing for COVID-19 Screening (COVISWAB)
Official title: Comparison for Sensitivity and Tolerance of Self-swabbing and Conventional Nasopharyngeal Swabbing for SARS-CoV-2 Detection for Pain, Discomfort and Acceptability: a Randomized Controlled Non-inferiority Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Covid19
Keywords: SARS-CoV-2
COVID-19
Nasopharyngeal swabbing
Self-swabbing
pain
Sensitivity
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2021-04-05
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized sequence of supervised self-swabbing and conventional swabbing for SARS-CoV-2 screening
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Non-inferiority of self-swabbing compared to conventional swabbing concerning diagnosis sensitivity
timeFrame: 5 minutes after the end of the procedure of nasopharyngeal swabbing
Secondary outcomes:
measure: Correlation between age, sex and swabbing-induced pain
timeFrame: 5 minutes after the end of the procedure
measure: Correlation between eye color and swabbing-induced pain
timeFrame: 5 minutes after the end of the procedure
measure: Correlation between eye color and swabbing-induced discomfort
timeFrame: 5 minutes after the end of the procedure
measure: Correlation between symptoms (fever, headache, asthenia, anosmia, agueusia, cough, dyspnea, muscle pain, sore throat, diarrhea) and swabbing-induced pain
timeFrame: 5 minutes after the end of the procedure
measure: Correlation between body mass index and swabbing-induced pain
timeFrame: 5 minutes after the end of the procedure
measure: Correlation between anticipated pain and actual pain
timeFrame: 5 minutes after the end of the procedure
measure: Correlation between anticipated discomfort and actual discomfort.
timeFrame: 5 minutes after the end of the procedure
measure: Richness assessment for respiratory cells
timeFrame: Day 0
measure: Non-inferiority of self-swabbing compared to conventional swabbing concerning pain
timeFrame: 5 minutes after the end of the procedure of nasopharyngeal swabbing
measure: Non-inferiority of self-swabbing compared to conventional swabbing concerning pain discomfort
timeFrame: 5 minutes after the end of the procedure of nasopharyngeal swabbing
measure: Non-inferiority of self-swabbing compared to conventional swabbing concerning acceptability
timeFrame: 5 minutes after the end of the procedure of nasopharyngeal swabbing
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Xavier MOISSET
role: PRINCIPAL_INVESTIGATOR
References: