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
研究概览
地位
条件
详细说明
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
研究类型
注册 (预期的)
联系人和位置
学习地点
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Tanta、埃及、31527
- 招聘中
- Tanta University Hospital
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接触:
- Mohammed Hassan Abu-Zaid, PhD
- 电话号码:+201006773622
- 邮箱:drmhassan113@yahoo.com
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接触:
- Samar A Tabra, PhD
- 电话号码:+201007501572
- 邮箱:dr_stabra_113@yahoo.com
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
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.
描述
Inclusion Criteria:
- Adult patients with rheumatoid arthritis superinfected with Covid-19
Exclusion Criteria:
- Insufficient data are available in the medical record.
学习计划
研究是如何设计的?
设计细节
- 观测模型:病例对照
- 时间观点:追溯
队列和干预
团体/队列 |
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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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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Number of patients in need for hospitalization
大体时间: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
大体时间: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
大体时间: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
大体时间: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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合作者和调查者
调查人员
- 学习椅:Asem Elfert, Prof、Tanta University Faculty of medicine
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 002 (University of CT Health Center)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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