Characterization of Kidney Involvement in COVID-19 Disease: a French Multi-center Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 4
- 主要终点
- Kidney involvement in COVID-19 disease
研究概览
简要总结
Novel coronavirus disease (COVID-19) is a newly discovered contagious disease caused by SARS-CoV-2 virus, primarily manifesting as an acute respiratory illness with pneumonia, but can affect multiple organs such as kidney, heart, digestive tract, blood and nervous system. In previous reports of SARS and MERS-CoV infections, acute kidney injury was described in 5 to 15% of patients and was associated with a high mortality rate (60-90%). Recent reports showed renal abnormalities in COVID-9 infected patients. A recent Chinese study also reported that acute kidney injury was an independent risk factor for mortality. However, the exact mechanism of kidney involvement remains unclear: sepsis-related cytokine storm or direct cellular injury from the virus. Also, kidney involvement has not yet been well characterized: heavy albuminuria, hematuria or interstitial nephropathy alone.
A recent study identified viral RNA in kidney tissue and another study succeeded isolating SARS-CoV-2 from the urine sample of an infected patient. These data suggest that the kidney might be a target of this novel coronarivus.
The sponsor suggests characterizing kidney involvement in SARS-CoV-2 infection.
Study objectives are:
- To give an accurate characterization of kidney involvement in COVID-19
- To investigate the physiopathologic mechanism of kidney involvement in SARS-CoV-2 infection
- To identify risk factors for kidney involvement in in SARS-CoV-2 infection
- To evaluate the impact of kidney involvement in in SARS-CoV-2 infection
- To assess the long-term health effect of kidney injury on survivors of in SARS-CoV-2 infection
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
- 否
入选标准
- •Confirmed COVID-19 disease
- •Age > 18 years-old
排除标准
- •Age < 18 years-old
- •Pregnancy
- •Patient with tutor- or curatorship or in prison
- •Patients who had undergone renal replacement therapy (RRT) before admission
结局指标
主要结局
Kidney involvement in COVID-19 disease
时间窗: until 3 months after discharge or death
Rate of kidney involvement in COVID-19 disease characterized by clinical and biological data
次要结局
- To evaluate the impact of kidney involvement in SARS-CoV-2 infection(until 3 months after discharge or death)
- Physiopathologic mechanism of kidney involvement in SARS-CoV-2 infection(until 3 months after discharge or death)
- To identify risk factors for kidney involvement in in SARS-CoV-2 infection(until 3 months after discharge or death)
- To assess the long-term health effect of kidney injury on survivors of SARS-CoV-2 infection in case of AKI KDIGO 2 or 3(until 3 months after discharge)