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Self- Versus Conventional-swabbing for COVID-19 Screening (COVISWAB) (COVISWAB)

2. april 2021 opdateret af: 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.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

400

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Frankrig
      • Clermont-Ferrand, Frankrig, 63000
        • CHU de Clermont-Ferrand

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Diagnostisk
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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
Andet: nasopharyngeal swabbing procedure (self swabbing first)
Patient realises the nasal swabbing himself first, then undergoes conventionnal swabbing
Eksperimentel: Conventional swabbing followed by supervised self-swabbing
the subject will undergo conventional nasopharyngeal swabbing performed by a trained healthcare professional first.
Andet: nasopharyngeal swabbing procedure (conventionnal swabbing first)
patient undergoes conventionnal swabbing first then realises the nasal swabbing himself

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Non-inferiority of self-swabbing compared to conventional swabbing concerning diagnosis sensitivity
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Correlation between age, sex and swabbing-induced pain
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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 body mass index and swabbing-induced pain
Tidsramme: 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
Tidsramme: 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.
Tidsramme: 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
Tidsramme: Day 0
Ct value of beta-globin gene
Day 0
Non-inferiority of self-swabbing compared to conventional swabbing concerning pain
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University Hospital, Clermont-Ferrand

Efterforskere

  • Ledende efterforsker: Xavier MOISSET, University Hospital, Clermont-Ferrand

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Forventet)

1. april 2021

Primær færdiggørelse (Forventet)

1. oktober 2021

Studieafslutning (Forventet)

1. december 2021

Datoer for studieregistrering

Først indsendt

1. april 2021

Først indsendt, der opfyldte QC-kriterier

2. april 2021

Først opslået (Faktiske)

5. april 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. april 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. april 2021

Sidst verificeret

1. marts 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • RBHP 2020 MOISSET 2
  • 2020-A02913-36 (Anden identifikator: ANSM)

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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