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
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Non-inferiority of self-swabbing compared to conventional swabbing concerning diagnosis sensitivity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Any subject coming for nasopharyngeal swabbing for SARS-CoV-2 screening
- •Fluent in French (both oral and written)
- •Able to give an eclaired consent
排除标准
- •Contra-indication to nasopharyngeal swabbing
- •Refusal to participate
- •Pregnant women
研究组 & 干预措施
Supervised self-swabbing followed by conventional swabbing
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
干预措施: nasopharyngeal swabbing procedure (self swabbing first) (Other)
Conventional swabbing followed by supervised self-swabbing
the subject will undergo conventional nasopharyngeal swabbing performed by a trained healthcare professional first.
干预措施: nasopharyngeal swabbing procedure (conventionnal swabbing first) (Other)
结局指标
主要结局
Non-inferiority of self-swabbing compared to conventional swabbing concerning diagnosis sensitivity
时间窗: 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.
次要结局
- Non-inferiority of self-swabbing compared to conventional swabbing concerning acceptability(5 minutes after the end of the procedure of nasopharyngeal swabbing)
- Correlation between body mass index and swabbing-induced pain(5 minutes after the end of the procedure)
- Non-inferiority of self-swabbing compared to conventional swabbing concerning pain(5 minutes after the end of the procedure of nasopharyngeal swabbing)
- 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)
- Correlation between anticipated pain and actual pain(5 minutes after the end of the procedure)
- Correlation between anticipated discomfort and actual discomfort.(5 minutes after the end of the procedure)
- Correlation between age, sex and swabbing-induced pain(5 minutes after the end of the procedure)
- Correlation between eye color and swabbing-induced pain(5 minutes after the end of the procedure)
- Correlation between eye color and swabbing-induced discomfort(5 minutes after the end of the procedure)
- Richness assessment for respiratory cells(Day 0)
- Non-inferiority of self-swabbing compared to conventional swabbing concerning pain discomfort(5 minutes after the end of the procedure of nasopharyngeal swabbing)