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Hydroxy Chloroquine and Covid in RA Patients (Covid-19)

2020年9月7日 更新者:Mohammed Hassan Abu-Zaid、Tanta University

Clinical Course of COVID-19 in Patients With Rheumatoid Arthritis Treated With or Without Hydroxychloroquine: a Case-control Study

evaluation of the clinical course of COVID-19 in a cohort of patients with rheumatoid arthritis treated with or without hydroxychloroquine.

研究概览

地位

未知

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:

  1. Epidemiologic, demographic, and clinical data.
  2. Severity of rheumatoid arthritis.
  3. Rheumatoid arthritis activity state using the Clinical Disease Activity Index
  4. Dose and duration of hydroxychloroquine
  5. Need for hospitalization, length of hospital stay, and ICU admission including the need for mechanical ventilation.
  6. Duration from the start of symptoms until clinical cure.
  7. Severity of COVID-19 disease according to the World Health Organization interim guidance
  8. Prognosis.

Laboratory investigations and imaging:

  1. Complete blood count.
  2. Renal and liver function tests.
  3. Random blood sugar.
  4. Lactate dehydrogenase, D-dimer.
  5. Serum ferritin, C-reactive protein,
  6. Chest radiographs or CT scan

研究类型

观察性的

注册 (预期的)

80

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Tanta、埃及、31527
        • 招聘中
        • Tanta University Hospital
        • 接触:
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

取样方法

概率样本

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

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

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
Experimental
Patient with rheumatoid arthritis using hydroxychloroquine as a part of their treatment regimen.
Active Comparator
Patient with rheumatoid arthritis not using hydroxychloroquine as a part of their treatment regimen

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
Estimate number of patients in need for hospitalization
through study completion an average 12 weeks
Length of hospitalization and ICU admission
大体时间:through study completion an average 12 weeks
Calculate the number of days that the patients stayed at the hospital and how many patients admitted to ICU
through study completion an average 12 weeks
The need for mechanical ventilation
大体时间:through study completion an average 12 weeks
Calculate the number of patients who received mechanical ventilation
through study completion an average 12 weeks
Severity of COVID-19 disease
大体时间:through study completion an average 12 weeks
WHO clinical management Covid19 interim guidance disease severity Algorithm
through study completion an average 12 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 学习椅:Asem Elfert, Prof、Tanta University Faculty of medicine

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2020年6月15日

初级完成 (预期的)

2020年10月1日

研究完成 (预期的)

2020年11月1日

研究注册日期

首次提交

2020年7月7日

首先提交符合 QC 标准的

2020年7月13日

首次发布 (实际的)

2020年7月15日

研究记录更新

最后更新发布 (实际的)

2020年9月9日

上次提交的符合 QC 标准的更新

2020年9月7日

最后验证

2020年9月1日

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)?

未定

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

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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