Self- Versus Conventional-swabbing for COVID-19 Screening (COVISWAB) (COVISWAB)
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.
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
-
-
-
Clermont-Ferrand、フランス、63000
- CHU de Clermont-Ferrand
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：診断
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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
|
Patient realises the nasal swabbing himself first, then undergoes conventionnal swabbing
|
|
実験的：Conventional swabbing followed by supervised self-swabbing
the subject will undergo conventional nasopharyngeal swabbing performed by a trained healthcare professional first.
|
patient undergoes conventionnal swabbing first then realises the nasal swabbing himself
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Non-inferiority of self-swabbing compared to conventional swabbing concerning diagnosis sensitivity
時間枠：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.
|
5 minutes after the end of the procedure of nasopharyngeal swabbing
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Correlation between age, sex and swabbing-induced pain
時間枠：5 minutes after the end of the procedure
|
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
時間枠：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)
|
5 minutes after the end of the procedure
|
|
Correlation between eye color and swabbing-induced discomfort
時間枠：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)
|
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
時間枠：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)
|
5 minutes after the end of the procedure
|
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Correlation between body mass index and swabbing-induced pain
時間枠：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)
|
5 minutes after the end of the procedure
|
|
Correlation between anticipated pain and actual pain
時間枠：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)
|
5 minutes after the end of the procedure
|
|
Correlation between anticipated discomfort and actual discomfort.
時間枠：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)
|
5 minutes after the end of the procedure
|
|
Richness assessment for respiratory cells
時間枠：Day 0
|
Ct value of beta-globin gene
|
Day 0
|
|
Non-inferiority of self-swabbing compared to conventional swabbing concerning pain
時間枠：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
|
5 minutes after the end of the procedure of nasopharyngeal swabbing
|
|
Non-inferiority of self-swabbing compared to conventional swabbing concerning pain discomfort
時間枠：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
|
5 minutes after the end of the procedure of nasopharyngeal swabbing
|
|
Non-inferiority of self-swabbing compared to conventional swabbing concerning acceptability
時間枠：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).
|
5 minutes after the end of the procedure of nasopharyngeal swabbing
|
協力者と研究者
捜査官
- 主任研究者：Xavier MOISSET、University Hospital, Clermont-Ferrand
研究記録日
主要日程の研究
研究開始 (予想される)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- RBHP 2020 MOISSET 2
- 2020-A02913-36 (その他の識別子：ANSM)
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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