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临床试验/NCT04345640
NCT04345640Unknown不适用

The Spectrum and Profile of COVID-19 Infection and Its Impact on Liver - The Pan Asia-Pacific Prospective Multi-centre Observational Study (APCOLIS STUDY)

Institute of Liver and Biliary Sciences, India1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2020年4月10日最近更新:
适应症

试验速览

阶段
不适用
入组人数
1,000
试验地点
1
主要终点
Spontaneous recovery or death in both groups

研究概览

简要总结

To address the existing deficiencies in the knowledge regarding liver involvement and spectrum of clinical presentation and the impact of COVID-19 infection in patients of liver disease was planned. The present study will be a hospital based and the cases of confirmed COVID-19 infection will be evaluated in relation to liver involvement irrespective of pre-existing liver disease. The primary objective was to address the clinical presentation, biochemical alteration and outcomes of COVID-19 infection in subjects with chronic hepatitis, cirrhosis in comparison to those having infection in the absence of pre-existing liver disease

研究设计

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

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients of COVID-19 positive
  • Age 18-70 years

排除标准

  • No Valid consent

结局指标

主要结局

Spontaneous recovery or death in both groups

时间窗: 90 days

次要结局

  • Improvement in severity assessment Indices Acute Physiology And Chronic Health Evaluation (APACHE) scores II in both groups(90 days)
  • Duration of prior as well as present decompensation in both groups(90 days)
  • Severity of prior as well as present decompensation in both groups(90 days)
  • Improvement in severity assessment Indices Chronic Liver Failure-Sequential Organ Failure Assessment (CLIF SOFA) scores in both groups.(90 days)
  • Improvement in severity assessment Indices Model for End Stage Liver Disease (MELD) scores in both groups(90 days)
  • Improvement in severity assessment Indices Child-Turcotte-Pugh (CTP) scores in both groups(90 days)
  • Improvement in severity assessment Indices Sequential Organ Failure Assessment (SOFA) scores in both groups(90 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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