- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04460690
Rapid, Onsite COVID-19 Detection
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Virtually all COVID-19 RNA assays require centralized laboratories. Samples collected in locations including public testing sites, workplaces, nursing homes, and residential housing are transported to centralized laboratories for testing, leading to lengthy delays in results reporting. The window of maximal contagiousness is thought to be only a few days, so these delays create the risk of excess transmission. Current testing methods are painful, which encourages testing hesitancy. Rapid, onsite detection of SARS-CoV-2 RNA from non-invasive saliva could overcome these issues and provide a pathway to high-throughput detection of people at the greatest risk of SARS-CoV-2 transmission but the logistics of such a testing program require real-world prototyping.
The investigators have developed a simple test to detect high concentrations of SARS-CoV-2 in saliva with assays that require no specialized equipment and can be completed in one hour. This assay is not diagnostic for SARS-CoV-2; instead, it specifically identifies saliva samples that have high amounts of viral RNA that are correlated with live virus shedding. Many samples that would be identified as SARS-CoV-2 by diagnostic qRT-PCR would be negative with this saliva assay. Conversely, detection of RNA in saliva is a potential finding of clinical significance, so participants with that result will be contacted by a medical professional to discuss potential follow-up with their own health care provider, including a possible independent diagnostic testing.
Because the assay requires no specialized equipment, it can be performed at the site of sample collection using a portable laboratory that fits in the backseat of a car. The prototype testing will take place in a variety of settings that may include parking lots, workplaces, nursing homes and residential housing. Participants will be asked to consent to provide a saliva sample that will be tested for SARS-CoV-2 RNA levels consistent with live virus shedding. The consent document will explicitly state that this is not a diagnostic test for SARS-CoV-2 but that a potential finding of clinical significance should be discussed with a medical professional. Participants can opt-out of receiving any results at the time of consent and can provide samples for the sole purpose of contributing to community surveillance and assay development. Paper consent forms will be reviewed and signed and held by team members in a secure location (locked box at the collection site) until taken back to the AIDS Vaccine Research Laboratory for storage. Participants will then spit into a coded vessel (e.g., cup or tube). Samples should be at least 1ml (~¼ teaspoon) and will be assayed for the presence of SARS-CoV-2 RNA using the aforementioned detection assay; the presence of high concentrations of SARS-CoV-2 RNA is indicated by a colorimetric change from pink to yellow/orange.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Wisconsin
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Madison, Wisconsin, Estados Unidos, 53711
- University of Wisconsin
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Willing to provide informed consent
- Willing to provide informed consent and spit into a vessel
- Individuals at least 5 years of age and have a parent or legal guardian present to consent if under 18 years
- Adult participants must have decision-making capacity to provide consent on their own behalf.
- Participants must be able to speak English
Exclusion Criteria:
- Under 18 years of age with no parent or legal guardian present or under the age of 5 yrs
- Participants must not have visual or hearing impairments, or low literacy, that would prevent them from reading the consent form and interacting with a member of the research team to ask questions and receive responses during the consent process
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Diagnóstico
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Rapid Onsite COVID-29 Testing
Community participants provide a saliva sample for a simple test to detect high concentrations of SARS-CoV-2 in saliva with assays that require no specialized equipment and can be completed in one hour.
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saliva assay test for high concentrations of SARS-CoV-2
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Number of Samples Tested
Periodo de tiempo: 15 minutes
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samples are tested and consistently shown that the assay can detect SARS-CoV-2 safely, consistently and accurately at multiple locations using the mobile laboratory.
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15 minutes
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Safety: Number of Participants Who Tested Positive for COVID-19
Periodo de tiempo: up to 2 months
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Feasibility is determined when at least 10000 samples are tested and consistently shown that the assay can detect SARS-CoV-2 safely, consistently and accurately at multiple locations using the mobile laboratory.
This testing protocol will be considered safe if COVID-19 rates of those performing the tests do not significantly exceed those of the communities in which the tests are being performed.
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up to 2 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: David O'Connor, PhD, University of Wisconsin, Madison
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2020-0855
- A536300 (Otro identificador: UW Madison)
- SMPH/PATHOL-LAB MED/ANAT PATH (Otro identificador: UW Madison)
- 5P51OD011106-59 (Subvención/contrato del NIH de EE. UU.)
- Protocol Version 8/30/2020 (Otro identificador: UW Madison)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Marco de tiempo para compartir IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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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