Covid19 Clinical Trial
— COVISWABOfficial 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
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.
Status | Not yet recruiting |
Enrollment | 400 |
Est. completion date | December 2021 |
Est. primary completion date | October 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | CHU de Clermont-Ferrand | Clermont-Ferrand |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Clermont-Ferrand |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Richness assessment for respiratory cells | Ct value of beta-globin gene | Day 0 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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