- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04710836
NoRCoRP Assessment Clinic (NoRCoRP)
The Nottingham Recovery From COVID-19 Research Platform Assessment Clinic
Descripción general del estudio
Estado
Condiciones
Descripción detallada
The severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2 / COVID-19) pandemic, has affected over 13 million people, and caused significant worldwide mortality and morbidity. Frequent long-term respiratory complications include persistent breathlessness and fatigue, with potential for ongoing organising pneumonia and new pulmonary fibrosis as well as thromboembolic disease. Additional features seen in at least some patients post hospital include impaired musculoskeletal function, impaired renal function, neurological impairment, cardiac dysfunction and significant psychiatric morbidity.
The majority of patients with COVID-19 were not admitted to hospital, and the longer-term consequences of infection with SARS-CoV-2 in this much larger patient group are unknown. Whilst many patients had relatively mild disease and made a good recovery, a significant number have been left with symptoms similar to those who were admitted to hospital.
In setting up a post COVID-19 respiratory review clinic, we expect to generate new findings, support studies that have already been submitted for funding, to provide a focus for further grant funding, and to provide an infrastructure to support new clinical trials. We also expect the insights gained from research using this platform to be of value for service planning in the region and beyond. We will prioritise patients who were not admitted to hospital but who have been left with significant morbidity by establishing this new General Practitioner (GP) referral research clinic.
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Charlotte Bolton
- Número de teléfono: 54844 01159 691169
- Correo electrónico: charlotte.bolton@nottingham.ac.uk
Copia de seguridad de contactos de estudio
- Nombre: Alex Jenkins
- Correo electrónico: alex.jenkins@nottingham.ac.uk
Ubicaciones de estudio
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Nottingham, Reino Unido, NG5 1PB
- Reclutamiento
- Nottingham City Hospital
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Contacto:
- Charlotte Bolton
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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
Descripción
Inclusion Criteria:
- Adults (≥18 years) referred into the post COVID-19 respiratory outpatient clinic from primary care, following a swab, imaging or strong clinical diagnosis of COVID-19
- Adults discharged from hospital with a clinical diagnosis of COVID-19 (who are not included in the PHOSP-COVID study)
Exclusion Criteria:
- Children (<18 years) referred into the post COVID-19 respiratory outpatient clinic. This clinic is only open to adults and referrals for children will not be accepted
- Adults discharged from hospital with a clinical diagnosis of COVID-19 and have been included in the PHOSP-COVID study
- Patients unable to provide informed consent by themselves
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Number of participants with symptoms at presentation to the research clinic
Periodo de tiempo: September 2020 - August 2024
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Patient reported symptoms
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September 2020 - August 2024
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Short Physical Performance Battery
Periodo de tiempo: September 2020 - August 2024
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Assessment of functional capacity
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September 2020 - August 2024
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Quadricep muscle strength
Periodo de tiempo: September 2020 - August 2024
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Assessment of functional capacity using a handheld dynamometer
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September 2020 - August 2024
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Chalder's Fatigue Score
Periodo de tiempo: September 2020 - August 2024
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Assessment of fatigue using the Chalder 11-item fatigue questionnaire
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September 2020 - August 2024
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Number of participants with rehabilitation needs at presentation to clinic
Periodo de tiempo: September 2020 - August 2024
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Rehabilitation needs based on clinical assessment by a multidisciplinary team (musculoskeletal, cognitive and cardiopulmonary)
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September 2020 - August 2024
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EQ-5D-5L
Periodo de tiempo: September 2020 - August 2024
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Assessment of generic health status using the EQ-5D-5L questionnaire
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September 2020 - August 2024
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Montreal Cognitive Assessment
Periodo de tiempo: September 2020 - August 2024
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Assessment of cognitive state using the MoCA questionnaire
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September 2020 - August 2024
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Anxiety and Depression
Periodo de tiempo: September 2020 - August 2024
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Derived by completion of the Hospital Anxiety and Depression Scale (HADS) questionnaire
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September 2020 - August 2024
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Pittsburgh Sleep Quality Index
Periodo de tiempo: September 2020 - August 2024
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Assessment of sleep quality using the PSQI questionnaire
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September 2020 - August 2024
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Healthcare service needs following COVID-19 diagnosis
Periodo de tiempo: September 2020 - August 2032
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Monitoring of NHS records for incidence of re-presentation to primary or secondary care related to COVID-19 complications and survival.
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September 2020 - August 2032
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Biological markers of recovery from COVID-19
Periodo de tiempo: September 2020 - August 2032
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Assessment of blood taken for clinical purposes (where available) including renal function, liver function, full blood count, HbA1C, Brain natriuretic peptide, vitamin D, thyroid function, C-reactive protein (CRP), Creatine kinase for markers of COVID-19 recovery.
Batched inflammatory and metabolic markers as well as whole blood DNA will also be assessed from stored samples.
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September 2020 - August 2032
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Fried Frailty Index
Periodo de tiempo: September 2020 - August 2024
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Frailty assessment covering: shrinking, exhaustion, physical activity, slowness and weakness domains.
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September 2020 - August 2024
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Body composition
Periodo de tiempo: September 2020 - August 2024
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Body composition derived from bioelectrical impedance analysis to determine: body mass index, fat free mass index, fat free mass (kg), fat mass (kg).
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September 2020 - August 2024
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Charlotte Bolton, University of Nottingham & Nottingham University Hospitals NHS Trust
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
- 20RM056
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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