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

2 de abril de 2021 actualizado por: 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.

Descripción general del estudio

Estado

Desconocido

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

400

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Diagnóstico
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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
Otro: nasopharyngeal swabbing procedure (self swabbing first)
Patient realises the nasal swabbing himself first, then undergoes conventionnal swabbing
Experimental: Conventional swabbing followed by supervised self-swabbing
the subject will undergo conventional nasopharyngeal swabbing performed by a trained healthcare professional first.
Otro: nasopharyngeal swabbing procedure (conventionnal swabbing first)
patient undergoes conventionnal swabbing first then realises the nasal swabbing himself

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Non-inferiority of self-swabbing compared to conventional swabbing concerning diagnosis sensitivity
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Correlation between age, sex and swabbing-induced pain
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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.
Periodo de tiempo: 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
Periodo de tiempo: Day 0
Ct value of beta-globin gene
Day 0
Non-inferiority of self-swabbing compared to conventional swabbing concerning pain
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

University Hospital, Clermont-Ferrand

Investigadores

  • Investigador principal: Xavier MOISSET, University Hospital, Clermont-Ferrand

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Anticipado)

1 de abril de 2021

Finalización primaria (Anticipado)

1 de octubre de 2021

Finalización del estudio (Anticipado)

1 de diciembre de 2021

Fechas de registro del estudio

Enviado por primera vez

1 de abril de 2021

Primero enviado que cumplió con los criterios de control de calidad

2 de abril de 2021

Publicado por primera vez (Actual)

5 de abril de 2021

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

5 de abril de 2021

Última actualización enviada que cumplió con los criterios de control de calidad

2 de abril de 2021

Última verificación

1 de marzo de 2021

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • RBHP 2020 MOISSET 2
  • 2020-A02913-36 (Otro identificador: ANSM)

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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