- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04320732
Risk Factors for Community- and Workplace Transmission of COVID-19
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Summary The data collected will identify real-life risk factors for getting the COVID-19 diagnosis.
The Oslo University Hospital/University of Oslo web-based solution "nettskjema" will be used to collect data and consent forms.
The impact of knowing the risk factors for COVID-19 is tremendous because it can enable governments to conduct more targeted public health measurements than today to reduce the spread of the virus.
Detailed description Research into an ongoing COVID-19 outbreak is difficult because patients are isolated, and supplies of personal protective equipment (PPE) supplies are limited. The risk of transmission to study personal is non-negligible even when PPE is available.
A study design based on an electronic questionnaire and consent from delivered from the Oslo University Hospital/University of Oslo, GDPR (General Data Protection Regulation) compliant "TSD" service has therefore been chosen.
The study will be a case-control study based on a combined electronic consent form and questionnaire that the participants will fill in using a smartphone and electronic identification.
The groups that will be included are:
- Hospitalized and non-hospitalized patients/persons with COVID-19 at all stages of the disease and after the disease
- Hospitalized patients without COVID-19
- Healthcare personal or other groups with an increased risk of COVID-19
- Healthy volunteers
Participants may be followed with repeated questionnaires prospectively.
Biological samples Biological samples may hold crucial information about the susceptibility to COVID-19 and for susceptibility to the progression of the disease. It is within the scope of the study to analyze such samples from a limited number of participants which will be asked to provide such samples or hospitalized patients that have surplus material. The material will be analyzed with non-genetic methods most suitable to provide such information.
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Arne Søraas, MD, PhD
- Número de teléfono: +4790652904
- Correo electrónico: Arne.Vasli.Lund.Soraas@rr-research.no
Copia de seguridad de contactos de estudio
- Nombre: John Arne Dahl, PhD
- Correo electrónico: j.a.dahl@medisin.uio.no
Ubicaciones de estudio
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Oslo, Noruega, 0424
- Reclutamiento
- Oslo University Hospital
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Contacto:
- John A Dahl, PhD
- Número de teléfono: +4741456596
- Correo electrónico: j.a.dahl@medisin.uio.no
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
The study will be a combined retrospective and prospective case-control study based on a combined electronic consent form and questionnaire that the study groups will fill in using a smartphone and electronic identification.
The groups that will be included are:
- Hospitalized and non-hospitalized patients/persons with COVID-19 at all stages of the disease and after the disease
- Hospitalized patients without COVID-19
- Healthcare personal or other groups with an increased risk of COVID-19
- Healthy volunteers
Probability sampling will be conducted, but not solely.
Descripción
Inclusion Criteria:
- Norwegian adult
Exclusion Criteria:
- Unable to consent
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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Individuals with COVID-19 infection
Confirmed by routine laboratory diagnosis. All types of COVID-19 disease from asymptomatic carriers to hospitalized patients can be included. Only subjects >18 years old will be included in the study. |
No intervention, only prospective observation of behavior will be conducted by a questionnaire.
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Individuals tested for COVID-19 infection with negative test
Confirmed by routine laboratory diagnosis
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No intervention, only prospective observation of behavior will be conducted by a questionnaire.
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Healthy individuals
Recruitet from the general population
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No intervention, only prospective observation of behavior will be conducted by a questionnaire.
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Risk groups for COVID-19 exposure
Including, but not limited to healthcare workers.
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No intervention, only prospective observation of behavior will be conducted by a questionnaire.
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Patients admitted to hospital
Without COVID-19 infection.
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No intervention, only prospective observation of behavior will be conducted by a questionnaire.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Rate of COVID-19 infection
Periodo de tiempo: 1 year
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Diagnosed with serology or direct viral detection
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1 year
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- REK-124170
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan 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. .