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

Study Overview
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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.

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.

Official Title
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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

Conditions
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Covid19

Intervention / Treatment
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* Other: nasopharyngeal swabbing procedure (self swabbing first)
* Other: nasopharyngeal swabbing procedure (conventionnal swabbing first)


Participation Criteria
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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 Exclusion Criteria: Contra-indication to nasopharyngeal swabbing Refusal to participate Pregnant women

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized sequence of supervised self-swabbing and conventional swabbing for SARS-CoV-2 screening
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supervised self-swabbing followed by conventional swabbing<br>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 | Other: nasopharyngeal swabbing procedure (self swabbing first)<br>* Patient realises the nasal swabbing himself first, then undergoes conventionnal swabbing<br>|
| Experimental: Conventional swabbing followed by supervised self-swabbing<br>the subject will undergo conventional nasopharyngeal swabbing performed by a trained healthcare professional first. | Other: nasopharyngeal swabbing procedure (conventionnal swabbing first)<br>* patient undergoes conventionnal swabbing first then realises the nasal swabbing himself<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-inferiority of self-swabbing compared to conventional swabbing concerning diagnosis sensitivity | assessed using consistency of COVID-19 RT-PCR results for both sampling modalities (Self- swabbing versus conventional-swabbing). If non-inferiority is confirmed on this criterion, pain will be tested. | 5 minutes after the end of the procedure of nasopharyngeal swabbing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between age, sex and swabbing-induced pain | Score on the pain numeric rating scale (0 to 10; higher scores meaning more pain) | 5 minutes after the end of the procedure | 
| Correlation between eye color and swabbing-induced pain | Eye-color self-reported by the subject on a validated 14 item scale and pain score on the numeric rating scale (NRS) (0 to 10; higher scores meaning more pain) | 5 minutes after the end of the procedure | 
| Correlation between eye color and swabbing-induced discomfort | Eye-color self-reported by the subject on a validated 14 item scale and discomfort score on numeric rating scale (0 to 10; higher scores meaning more discomfort) | 5 minutes after the end of the procedure | 
| Correlation between symptoms (fever, headache, asthenia, anosmia, agueusia, cough, dyspnea, muscle pain, sore throat, diarrhea) and swabbing-induced pain | symptoms self-reported by the subject and pain score on numeric rating scale (0 to 10; higher scores meaning more pain) | 5 minutes after the end of the procedure | 
| Correlation between body mass index and swabbing-induced pain | symptoms self-reported by the subject and pain score on numeric rating scale (0 to 10; higher scores meaning more pain) | 5 minutes after the end of the procedure | 
| Correlation between anticipated pain and actual pain | anticipated and actual pain self-reported on numeric rating scale (0 to 10; higher scores meaning more pain) | 5 minutes after the end of the procedure | 
| Correlation between anticipated discomfort and actual discomfort. | anticipated and actual discomfort self-reported on numeric rating scale (0 to 10; higher scores meaning more pain) | 5 minutes after the end of the procedure | 
| Richness assessment for respiratory cells | Ct value of beta-globin gene | Day 0 | 
| Non-inferiority of self-swabbing compared to conventional swabbing concerning pain | assessed using a Numerical Rating Scale (0 indicating no pain and 10 the worst imaginable pain). If non-inferiority is confirmed on this criterion, discomfort will be tested | 5 minutes after the end of the procedure of nasopharyngeal swabbing | 
| Non-inferiority of self-swabbing compared to conventional swabbing concerning pain discomfort | assessed using a Numerical Rating Scale (0 indicating no discomfort and 10 the worst imaginable discomfort). If non-inferiority is confirmed on this criterion, acceptability will be tested | 5 minutes after the end of the procedure of nasopharyngeal swabbing | 
| Non-inferiority of self-swabbing compared to conventional swabbing concerning acceptability | assessed using a Numerical Rating Scale (0 indicating that the procedure is not acceptable at all and 10 that the procedure is perfectly well accepted). | 5 minutes after the end of the procedure of nasopharyngeal swabbing | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SARS-CoV-2, COVID-19, Nasopharyngeal swabbing, Self-swabbing, pain, Sensitivity