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临床试验/NCT04459351
NCT04459351Unknown不适用

PHenotyping patiENts Admitted to Hospital With cOvid-19 Infection and idenTifYing Prognostic markErs

Chelsea and Westminster NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2020年6月19日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
500
试验地点
1
主要终点
Identification of blood biomarkers which correlate with disease severity

研究概览

简要总结

PHENOTYPE is an investigator-led, observational cohort study which aims to explore the long-term outcomes of patients with COVID-19 infection and to identify potential risk factors and biomarkers that can prognosticate disease severity and trajectory.

详细描述

In 2019, a novel coronavirus, SARS-CoV-2 was first identified in Wuhan, China. SARS-CoV-2 infection, denominated COVID-19, causes a predominantly respiratory illness, which varies from mild respiratory symptoms to multi-organ failure and death. In March 2020, COVID-19 was designated pandemic status and as of May 2020 there have been more than 3.7 million cases reported worldwide and 257,000 deaths attributed. In the UK, COVID-19 has caused more than 30,000 deaths to date.

Although respiratory symptoms are the commonest presentation, numerous systemic complications of COVID-19 have been identified, including those affecting the cardiovascular, neurological, gastroenterological, and renal systems. The long-term impact of these complications on survivors and the risk factors for long term sequelae is not presently known. It is likely that increased frailty and psychological sequelae will be significant, which could lead to a persistent reduction in quality of life, as observed in the previous SARS pandemic.

This cohort study aims to evaluate the respiratory, cardiac, renal and psychological outcomes of patients diagnosed with COVID-19 infection and determine the pathophysiological mechanisms that contribute to disease severity and disease burden.

研究设计

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

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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Identification of blood biomarkers which correlate with disease severity

时间窗: Based on clinical need - Up to 1 year follow up.

Relationship between changes in markers of inflammation (CRP, D dimer, ferritin, fibrinogen, pro-calcitonin) and pulmonary, renal and cardiac complications post hospitalisation for Covid-19 infection.

Identification of baseline characteristics which correlate with disease severity

时间窗: Based on clinical need - Up to 1 year follow up.

The primary purpose is to characterise the different presentations and features of COVID-19 and outcomes.

Genomic analysis of blood samples to look for genetic susceptibility to severe disease presentations

时间窗: Based on clinical need - Up to 1 year follow up.

Genomic, proteomic and transcriptomic analysis of blood samples to look for genetic susceptibility to severe disease presentations and to identify new biomarkers that predict disease severity or disease trajectory

次要结局

  • Change in frailty and quality of life scores(Based on clinical need - Up to 1 year follow up.)
  • Relationship between serum markers and clinical outcomes(Based on clinical need - Up to 1 year follow up.)
  • Incidence(Based on clinical need - Up to 1 year follow up.)
  • Change in respiratory symptom scores(Based on clinical need - Up to 1 year follow up.)

研究者

发起方
Chelsea and Westminster NHS Foundation Trust
申办方类型
Other
责任方
Sponsor

研究点 (1)

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