Self- Versus Conventional-swabbing for COVID-19 Screening (COVISWAB) (COVISWAB)
2. April 2021 aktualisiert von: University Hospital, Clermont-Ferrand
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.
Studienübersicht
Status
Unbekannt
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Voraussichtlich)
400
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Clermont-Ferrand, Frankreich, 63000
- CHU de Clermont-Ferrand
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Ja
Studienberechtigte Geschlechter
Alle
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Diagnose
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: 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
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Patient realises the nasal swabbing himself first, then undergoes conventionnal swabbing
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Experimental: Conventional swabbing followed by supervised self-swabbing
the subject will undergo conventional nasopharyngeal swabbing performed by a trained healthcare professional first.
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patient undergoes conventionnal swabbing first then realises the nasal swabbing himself
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Non-inferiority of self-swabbing compared to conventional swabbing concerning diagnosis sensitivity
Zeitfenster: 5 minutes after the end of the procedure of nasopharyngeal swabbing
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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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Correlation between age, sex and swabbing-induced pain
Zeitfenster: 5 minutes after the end of the procedure
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Score on the pain numeric rating scale (0 to 10; higher scores meaning more pain)
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5 minutes after the end of the procedure
|
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Correlation between eye color and swabbing-induced pain
Zeitfenster: 5 minutes after the end of the procedure
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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)
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5 minutes after the end of the procedure
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Correlation between eye color and swabbing-induced discomfort
Zeitfenster: 5 minutes after the end of the procedure
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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)
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5 minutes after the end of the procedure
|
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Correlation between symptoms (fever, headache, asthenia, anosmia, agueusia, cough, dyspnea, muscle pain, sore throat, diarrhea) and swabbing-induced pain
Zeitfenster: 5 minutes after the end of the procedure
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symptoms self-reported by the subject and pain score on numeric rating scale (0 to 10; higher scores meaning more pain)
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5 minutes after the end of the procedure
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Correlation between body mass index and swabbing-induced pain
Zeitfenster: 5 minutes after the end of the procedure
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symptoms self-reported by the subject and pain score on numeric rating scale (0 to 10; higher scores meaning more pain)
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5 minutes after the end of the procedure
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Correlation between anticipated pain and actual pain
Zeitfenster: 5 minutes after the end of the procedure
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anticipated and actual pain self-reported on numeric rating scale (0 to 10; higher scores meaning more pain)
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5 minutes after the end of the procedure
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Correlation between anticipated discomfort and actual discomfort.
Zeitfenster: 5 minutes after the end of the procedure
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anticipated and actual discomfort self-reported on numeric rating scale (0 to 10; higher scores meaning more pain)
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5 minutes after the end of the procedure
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Richness assessment for respiratory cells
Zeitfenster: Day 0
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Ct value of beta-globin gene
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Day 0
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Non-inferiority of self-swabbing compared to conventional swabbing concerning pain
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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).
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5 minutes after the end of the procedure of nasopharyngeal swabbing
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Ermittler
- Hauptermittler: Xavier MOISSET, University Hospital, Clermont-Ferrand
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Voraussichtlich)
1. April 2021
Primärer Abschluss (Voraussichtlich)
1. Oktober 2021
Studienabschluss (Voraussichtlich)
1. Dezember 2021
Studienanmeldedaten
Zuerst eingereicht
1. April 2021
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
2. April 2021
Zuerst gepostet (Tatsächlich)
5. April 2021
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
5. April 2021
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
2. April 2021
Zuletzt verifiziert
1. März 2021
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- RBHP 2020 MOISSET 2
- 2020-A02913-36 (Andere Kennung: ANSM)
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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