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临床试验/NCT04386564
NCT04386564已完成不适用

Prospective Parallel-Group Study of the Relationship Between Kidney Injury Severity and Severity of COVID-19

I.M. Sechenov First Moscow State Medical University1 个研究点 分布在 1 个国家目标入组 340 人开始时间: 2020年5月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
340
试验地点
1
主要终点
The effect of COVID-19 severity on the severity of renal failure

研究概览

简要总结

The authors hypothesize that the SARS-CoV-2 virus can affect the kidneys, causing them to be damaged. The present study aims to explain the mechanisms of kidney injury in patients diagnosed with COVID-19.

详细描述

In December 2019, an outbreak of the 2019 novel coronavirus disease (COVID-19) caused by the SARS coronavirus 2 (SARS-CoV-2) occurred in Wuhan, China. It has spread rapidly to other areas in China and worldwide. The most common manifestations of COVID-19 included fever, dry cough, dyspnea, myalgia, fatigue and radiographic evidence of pneumonia. Complications (acute respiratory distress syndrome, shock, acute cardiac injury, secondary infection, and acute kidney injury) and death may occur in severe cases. Recent reports showed that extrapulmonary symptoms (intestinal symptoms in 10-20% of patients) and renal failure in some patients may be associated with the interaction of the virus with angiotensin-converting enzyme 2 (ACE-2) receptors in other organs. It was suggested that ACE-2 expression in the kidneys can be the cause of kidney injury occurring in a number of patients with SARS-CoV-2.However, ACE-2 is not the only possible cause of kidney injury - sepsis-related cytokine storm can also lead to damage of kidney parenchyma.

The present study aims to explain the mechanisms of kidney injury in patients diagnosed with COVID-19.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Pneumonia confirmed by CT scans

排除标准

  • a history of chronic renal failure;
  • a history of kidney transplantation;
  • intake of substances with a history of renal toxicity (no later than a month before inclusion);
  • patients with a single kidney;
  • refusal of the patient to participate in the study;
  • absence of SARS-CoV-2 virus smear from the nasopharynx in PCR.

结局指标

主要结局

The effect of COVID-19 severity on the severity of renal failure

时间窗: 2 months

estimated glomerular filtration rate (eGFR), ml/min, in groups with mild, moderate and severe COVID-19

次要结局

  • Expression of ACE-2 receptors in the kidneys of patients with renal failure who died from COVID-19(2 months)
  • The expression of viral RNA in the urine with the severity of renal failure(2 months)
  • Estimation of the duration of urinary viral RNA isolation in patients undergoing COVID-19(2 months)
  • Assessment of the severity of renal impairment in patients who died from COVID-19(2 months)
  • The severity of microalbuminuria in patients with COVID-19 of different conditions and renal failure(2 months)

研究者

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

Dmitry Enikeev, MD, PhD

Deputy Director for Research

I.M. Sechenov First Moscow State Medical University

研究点 (1)

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