- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04953247
Use of Compromised Lung Volume in Monitoring Usage of Steroid Therapy on Severe COVID-19
Descripción general del estudio
Estado
Descripción detallada
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Shanghai, Porcelana
- Zhongshan hospital, Fudan university
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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:
- (1) age 18-90 years
- (2) patients with severe or critical COVID-19.
Exclusion Criteria:
- (1) hematological or solid malignancies
- (2) patients with less than two CT scans during hospital stay
- (3) systemic corticosteroid or immunosuppressive therapy in the previous 6 weeks.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Methylprednisolone
As there was no consensus on the use of steroids in the early stage of the COVID-19 pandemic, all steroid therapies were initiated at the time of admission at the discretion of attending physicians on the basis of clinical symptoms and CT images. According to our previous experience, intravenous methylprednisolone at a dose of 1.0-1.5 mg/kg every 12 h was initiated for 5 days or until oxygen saturation improved, followed by gradual tapering by 0.5 mg/kg every 3-5 days. Standard care such as the use of antibiotics, ventilation, laboratory testing, and hemodynamic management were performed following the sixth edition of the Guidelines on the Diagnosis and Treatment of COVID-19 published by the National Health Commission of China. |
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Standard care
Standard care were performed following the sixth edition of the Guidelines on the Diagnosis and Treatment of COVID-19 published by the National Health Commission of China.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Changes in the percentage of compromised lung volume (Δ%CL) at different stages
Periodo de tiempo: 31 days
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According to different Hounsfield unit (HU) intervals in the quantitative chest CT scan, we divided each lung into nonaerated lung volume (%NNL, 100 to -100 HU), poorly aerated lung volume (%PAL, -101 to -500 HU), normally aerated lung volume (%NAL, -501 to -900 HU), and hyperinflated lung volume (%HI, -901 to -1000 HU) regions. The additional "compromised lung" volume (%CL) was considered as the sum of %PAL and %NNL (-500 to 100 HU). To monitor COVID-19 progression during the treatment process, we chose changes in the percentage of compromised lung volume (Δ%CL) at different stages (Δ%CL = %CL at different stages-baseline %CL) as the primary outcome. The negative value of Δ%CL thus reflected clinical improvement. |
31 days
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Changes in the percentage of NNL at different stages
Periodo de tiempo: 31 days
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According to different Hounsfield unit (HU) intervals in the quantitative chest CT scan, we divided each lung into nonaerated lung volume (%NNL, 100 to -100 HU), poorly aerated lung volume (%PAL, -101 to -500 HU), normally aerated lung volume (%NAL, -501 to -900 HU), and hyperinflated lung volume (%HI, -901 to -1000 HU) regions.
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31 days
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Changes in the percentage of PAL at different stages
Periodo de tiempo: 31 days
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According to different Hounsfield unit (HU) intervals in the quantitative chest CT scan, we divided each lung into nonaerated lung volume (%NNL, 100 to -100 HU), poorly aerated lung volume (%PAL, -101 to -500 HU), normally aerated lung volume (%NAL, -501 to -900 HU), and hyperinflated lung volume (%HI, -901 to -1000 HU) regions.
Under these circumstances, clinical improvement was reflected by the negative value of Δ%NNL and Δ%PAL, and the positive value of Δ%NAL.
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31 days
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Changes in the percentage of NAL at different stages
Periodo de tiempo: 31 days
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According to different Hounsfield unit (HU) intervals in the quantitative chest CT scan, we divided each lung into nonaerated lung volume (%NNL, 100 to -100 HU), poorly aerated lung volume (%PAL, -101 to -500 HU), normally aerated lung volume (%NAL, -501 to -900 HU), and hyperinflated lung volume (%HI, -901 to -1000 HU) regions.
Under these circumstances, clinical improvement was reflected by the negative value of Δ%NNL and Δ%PAL, and the positive value of Δ%NAL.
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31 days
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Changes in the percentage of HL at different stages
Periodo de tiempo: 31 days
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According to different Hounsfield unit (HU) intervals in the quantitative chest CT scan, we divided each lung into nonaerated lung volume (%NNL, 100 to -100 HU), poorly aerated lung volume (%PAL, -101 to -500 HU), normally aerated lung volume (%NAL, -501 to -900 HU), and hyperinflated lung volume (%HI, -901 to -1000 HU) regions.
Under these circumstances, clinical improvement was reflected by the negative value of Δ%NNL and Δ%PAL, and the positive value of Δ%NAL.
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31 days
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
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Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
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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
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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
- CLVMUST
Plan de datos de participantes individuales (IPD)
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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.
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