此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

COVID-19 Disease Duration and GIT Manifestations. A New Disease Severity Classification. An Egyptian Experience

2020年9月19日 更新者:Mona Hegazy、Cairo University

Corona Virus (COVID-19) Disease Duration and Gastrointestinal Tract (GIT) Manifestations; Can be New Disease Severity Classification. A Pilot Egyptian Single National Center Experience

The present study conducted to correlate symptoms not only constitutional and respiratory, but GIT as a principle presentation, with laboratory markers and COVID-19 severe acute respiratory syndrome (SARS-COV2) disease outcomes, as the duration of symptoms varies substantially between patients; the investigators undertook this study to determine the optimal time to predict COVID-19 outcomes based on real-time experience.

研究概览

地位

完全的

详细说明

This observational retrospective cohort single center national study was conducted on patients who tested positive COVID-19 infection by the polymerase chain reaction (PCR) of nasopharyngeal sample in the period from first June to the med of July 2020. Patients were recruited from Kasr Al-Aini School of medicine, COVID-19 out-patient clinic, Cairo University hospitals.

The diagnosis and classification of severity of COVID-19 infection were made according to the clinical management of COVID-19, released by the World Health Organization (WHO), mild and moderate case were recruited, the treatment protocol used was according to the Egyptian ministry of health treatment recommendations, which met in part the criteria that was later on published by the national institute of health, Mild and moderate cases once diagnosed by PCR received hydroxychloroquine 400 mg twice daily first day and maintained on 200 mg twice daily for 6 days in mild cases and 10 days in moderate cases. Also they received anticoagulants, vitamin c and zinc. In case of secondary bacterial infection, empiric antibiotics are started till result of sputum culture and sensitivity. Steroids were initiated in hypoxic cases that required supplemental oxygen and in cases of persistent symptoms.

Any adult patient (age ≥18 years) suffering from mild or moderate COVID-19 infection was included in this study. While severe cases according to WHO classifications and patients aged less than18 were excluded from the study.

研究类型

观察性的

注册 (实际的)

199

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

      • Cairo、埃及
        • Faculty of Medicine Cairo University

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

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Patients was recruited from COVID19 out-patient clinic, Cairo University hospitals. Severity Classification made according to the WHO (13) and Egyptian ministry of health treatment recommendations (14) Clinical data was collected including patient demographics (age, gender, weight and height, body mass index, comorbid conditions (e.g.diabetes mellitus, chronic pulmonary disease), vital signs. Clinical symptoms were recorded using yes/no checklist about constitutional symptoms, respiratory symptoms, loss of taste, loss of smell and gastrointestinal symptoms.The patients were followed up daily; by telehealth through phone calls and commercial video chat platforms, till symptoms offset. Laboratory assessment was collected within 24 hours of symptoms onset (complete blood picture, kidney and liver biochemistry, random blood sugar, serum C-reactive protein, D-dimer, ferritin, lipid profile, and lactate dehydrogenase). CT chest was performed and its result was recorded

描述

Inclusion Criteria:

  • Mild and moderate COVID-19 patients:

Exclusion Criteria:

  • Age less than 18 years
  • Severe COVID-19 patients: with dyspnea, hypoxia, or >50 percent lung involvement on imaging within 24 to 48 hours
  • Critical COVID-19 patients: with respiratory failure, shock, or multiorgan dysfunction

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:队列
  • 时间观点:追溯

队列和干预

团体/队列
干预/治疗
Group 1
Duration of COVID-19 symptoms less than 12 days
hydroxychloroquine 400 mg twice daily first day and maintained on 200 mg twice daily for 6 days in mild cases and 10 days in moderate cases. Also they received anticoagulants, vitamin c and zinc. In case of secondary bacterial infection, empiric antibiotics are started
其他名称:
  • 皮质类固醇
  • 抗凝物
  • 抗生素
  • vitamin c pill
  • zinc pill
Group 2
Duration of COVID-19 symptoms equal or more than 12 days
hydroxychloroquine 400 mg twice daily first day and maintained on 200 mg twice daily for 6 days in mild cases and 10 days in moderate cases. Also they received anticoagulants, vitamin c and zinc. In case of secondary bacterial infection, empiric antibiotics are started
其他名称:
  • 皮质类固醇
  • 抗凝物
  • 抗生素
  • vitamin c pill
  • zinc pill

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
COVID-19 disease spectrum and duration
大体时间:july 2020 to june 2020
The investigators tried to correlate disease severity with disease duration
july 2020 to june 2020
GIT manifestations among COVID-19 patients
大体时间:july 2020 to june 2020
spectrum of GIT manifestations in COVID-19 patients was investigated
july 2020 to june 2020

次要结果测量

结果测量
措施说明
大体时间
Non-communicable disease and COVID-19
大体时间:july 2020 to june 2020
The link between non-communicable disease (including diabetes, hypertension and Hypercholesterolemia) severity and COVID-19 prognosis
july 2020 to june 2020
Seasonal change and COVID-19
大体时间:july 2020 to june 2020
the investigators studied the Impact of weather climate on COVID-19 presentations (higher incidence of diarrhea in COVID-19 patients in summer) and outcomes
july 2020 to june 2020
Possible region specific classification for COVID-19 disease
大体时间:july 2020 to june 2020
The investigators tried to find new Egyptian classification fro COVID-19 disease severity
july 2020 to june 2020

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

  • 首席研究员:Mona M Hegazy, MD、Professor of Internal Medicine Hepatology & gastroenterology Unit. Faculty of medicine Cairo University
  • 研究主任:Ahmed M Abdul Ghani, MD、Lecturer of Internal Medicine Hepatology & gastroenterology Unit. Faculty of medicine Cairo University
  • 学习椅:Rania M Lithy, MD、Lecturer of Endemic medicine and hepatogastroenterology. Faculty of medicine Cairo University
  • 学习椅:Hoda M abdel-Hamid, MD、Lecturer of Respiratory medicine. Faculty of medicine Cairo University
  • 学习椅:Mahmoud Wahba, MD、Lecturer of Internal Medicine Division of Gastroenterology, Kasr Alainy . Faculty of Medicine, Cairo University
  • 学习椅:Omar Ashoush, MD、Lecturer of Internal Medicine Hepatology & gastroenterology Unit. Faculty of medicine Cairo University
  • 学习椅:Mohamed Tharwat Hegazy, MD、Lecturer of Internal Medicine Department, Rheumatology and Clinical Immunology unit, Faculty of Medicine, Cairo University

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。

一般刊物

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1日

初级完成 (实际的)

2020年7月15日

研究完成 (实际的)

2020年7月15日

研究注册日期

首次提交

2020年9月12日

首先提交符合 QC 标准的

2020年9月17日

首次发布 (实际的)

2020年9月18日

研究记录更新

最后更新发布 (实际的)

2020年9月22日

上次提交的符合 QC 标准的更新

2020年9月19日

最后验证

2020年9月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

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.

订阅