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临床试验/NCT04554979
NCT04554979已完成不适用

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

Cairo University1 个研究点 分布在 1 个国家目标入组 199 人开始时间: 2020年6月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
199
试验地点
1
主要终点
COVID-19 disease spectrum and duration

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Mild and moderate COVID-19 patients:

排除标准

  • 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

研究组 & 干预措施

Group 1

Duration of COVID-19 symptoms less than 12 days

干预措施: Hydroxychloroquine Pill (Drug)

Group 2

Duration of COVID-19 symptoms equal or more than 12 days

干预措施: Hydroxychloroquine Pill (Drug)

结局指标

主要结局

COVID-19 disease spectrum and duration

时间窗: july 2020 to june 2020

The investigators tried to correlate disease severity with disease duration

GIT manifestations among COVID-19 patients

时间窗: july 2020 to june 2020

spectrum of GIT manifestations in COVID-19 patients was investigated

次要结局

  • Non-communicable disease and COVID-19(july 2020 to june 2020)
  • Possible region specific classification for COVID-19 disease(july 2020 to june 2020)
  • Seasonal change and COVID-19(july 2020 to june 2020)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mona Hegazy

Professor of Internal Medicine Hepatology & gastroenterology Unit Faculty of medicine

Cairo University

研究点 (1)

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