Covid19
Conditions
Keywords
SARS-CoV-2, COVID-19, Nasopharyngeal swabbing, Self-swabbing, pain, Sensitivity
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.
Interventions
OTHERnasopharyngeal swabbing procedure (self swabbing first)
Patient realises the nasal swabbing himself first, then undergoes conventionnal swabbing
OTHERnasopharyngeal swabbing procedure (conventionnal swabbing first)
patient undergoes conventionnal swabbing first then realises the nasal swabbing himself
Sponsors
University Hospital, Clermont-Ferrand
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Randomized sequence of supervised self-swabbing and conventional swabbing for SARS-CoV-2 screening
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Non-inferiority of self-swabbing compared to conventional swabbing concerning diagnosis sensitivity | 5 minutes after the end of the procedure of nasopharyngeal swabbing | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between eye color and swabbing-induced pain | 5 minutes after the end of the procedure | 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) |
| Correlation between eye color and swabbing-induced discomfort | 5 minutes after the end of the procedure | 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) |
| Correlation between symptoms (fever, headache, asthenia, anosmia, agueusia, cough, dyspnea, muscle pain, sore throat, diarrhea) and swabbing-induced pain | 5 minutes after the end of the procedure | symptoms self-reported by the subject and pain score on numeric rating scale (0 to 10; higher scores meaning more pain) |
| Correlation between body mass index and swabbing-induced pain | 5 minutes after the end of the procedure | symptoms self-reported by the subject and pain score on numeric rating scale (0 to 10; higher scores meaning more pain) |
| Correlation between anticipated pain and actual pain | 5 minutes after the end of the procedure | anticipated and actual pain self-reported on numeric rating scale (0 to 10; higher scores meaning more pain) |
| Correlation between age, sex and swabbing-induced pain | 5 minutes after the end of the procedure | Score on the pain numeric rating scale (0 to 10; higher scores meaning more pain) |
| Richness assessment for respiratory cells | Day 0 | Ct value of beta-globin gene |
| Non-inferiority of self-swabbing compared to conventional swabbing concerning pain | 5 minutes after the end of the procedure of nasopharyngeal swabbing | 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 |
| Non-inferiority of self-swabbing compared to conventional swabbing concerning pain discomfort | 5 minutes after the end of the procedure of nasopharyngeal swabbing | 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 |
| Non-inferiority of self-swabbing compared to conventional swabbing concerning acceptability | 5 minutes after the end of the procedure of nasopharyngeal swabbing | 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). |
| Correlation between anticipated discomfort and actual discomfort. | 5 minutes after the end of the procedure | anticipated and actual discomfort self-reported on numeric rating scale (0 to 10; higher scores meaning more pain) |
Countries
France
Contacts
Primary ContactLise LACLAUTRE
Outcome results
None listed