Hydroxy Chloroquine and Covid in RA Patients (Covid-19)
Clinical Course of COVID-19 in Patients With Rheumatoid Arthritis Treated With or Without Hydroxychloroquine: a Case-control Study
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Study settings & sample:
This is an observational, retrospective -case-control, single-center study. This study will include patients who meet the inclusion criteria followed in the Department of Rheumatology and Rehabilitation, Tanta University Hospital, Tanta, Egypt.
Data will be taken from the medical records of patients with rheumatoid arthritis in the outpatient clinic of the Rheumatology and Rehabilitation Department, Tanta University Hospital, Tanta, Egypt. All patients will sign the informed consent form authorizing the collection of these data.
Group classification A) Patients with rheumatoid arthritis using hydroxychloroquine as a part of their treatment regimen.
b) Patients with rheumatoid arthritis not using hydroxychloroquine as a part of their treatment regimen.
Data will be collected and analyzed from patient medical records. It will include the following:
- Epidemiologic, demographic, and clinical data.
- Severity of rheumatoid arthritis.
- Rheumatoid arthritis activity state using the Clinical Disease Activity Index
- Dose and duration of hydroxychloroquine
- Need for hospitalization, length of hospital stay, and ICU admission including the need for mechanical ventilation.
- Duration from the start of symptoms until clinical cure.
- Severity of COVID-19 disease according to the World Health Organization interim guidance
- Prognosis.
Laboratory investigations and imaging:
- Complete blood count.
- Renal and liver function tests.
- Random blood sugar.
- Lactate dehydrogenase, D-dimer.
- Serum ferritin, C-reactive protein,
- Chest radiographs or CT scan
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Ubicaciones de estudio
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Tanta, Egipto, 31527
- Reclutamiento
- Tanta University Hospital
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Contacto:
- Mohammed Hassan Abu-Zaid, PhD
- Número de teléfono: +201006773622
- Correo electrónico: drmhassan113@yahoo.com
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Contacto:
- Samar A Tabra, PhD
- Número de teléfono: +201007501572
- Correo electrónico: dr_stabra_113@yahoo.com
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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
To Evaluaye the clinical course of COVID-19 in a cohort of patients with rheumatoid arthritis treated with or without hydroxychloroquine:
Data will be taken from the medical records of patients with rheumatoid arthritis in the outpatient clinic of the Rheumatology and Rehabilitation department, Tanta University hospital, Tanta, Egypt.
A) Patient with rheumatoid arthritis using hydroxychloroquine as a part of their treatment regimen.
b) Patient with rheumatoid arthritis not using hydroxychloroquine as a part of their treatment regimen.
Primary Outcome Measures:
1. Impact of hydroxychloroquine on the clinical course of Covid-19 in the hydroxychloroquine group compared to the non- hydroxychloroquine group.
Data will be collected and analyzed from patient medical records.
Descripción
Inclusion Criteria:
- Adult patients with rheumatoid arthritis superinfected with Covid-19
Exclusion Criteria:
- Insufficient data are available in the medical record.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Control de caso
- Perspectivas temporales: Retrospectivo
Cohortes e Intervenciones
Grupo / Cohorte |
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Experimental
Patient with rheumatoid arthritis using hydroxychloroquine as a part of their treatment regimen.
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Active Comparator
Patient with rheumatoid arthritis not using hydroxychloroquine as a part of their treatment regimen
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Number of patients in need for hospitalization
Periodo de tiempo: through study completion an average 12 weeks
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Estimate number of patients in need for hospitalization
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through study completion an average 12 weeks
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Length of hospitalization and ICU admission
Periodo de tiempo: through study completion an average 12 weeks
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Calculate the number of days that the patients stayed at the hospital and how many patients admitted to ICU
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through study completion an average 12 weeks
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The need for mechanical ventilation
Periodo de tiempo: through study completion an average 12 weeks
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Calculate the number of patients who received mechanical ventilation
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through study completion an average 12 weeks
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Severity of COVID-19 disease
Periodo de tiempo: through study completion an average 12 weeks
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WHO clinical management Covid19 interim guidance disease severity Algorithm
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through study completion an average 12 weeks
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Asem Elfert, Prof, Tanta University Faculty of Medicine
Publicaciones y enlaces útiles
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
Palabras clave
Otros números de identificación del estudio
- 002 (University of CT Health Center)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (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.
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