Molecular Characterization and Cellular Infection Capacity of Urinary Viral Particles Isolated From SARS-CoV-2 and Association With Proximal Tubular Dysfunction, in Hospitalized Patients With COVID-19
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- SARS-CoV 2 viruria and its correlation with proximal tubule dysfunction
研究概览
简要总结
The primary goal is to detect Severe Acute Respiratory Syndrome CoronaVirus 2 (SARS-CoV2) urine viral particles in patients in intensive care units, hospitalized for coronavirus Coronavirus Disease-19 (COVID-19) infection, and correlate the presence of the virus in the urine with proximal tubular dysfunction (defined by the association of at least 2 abnormalities: tubular proteinuria, renal phosphate leak, uricosuria, normoglycemic glycosuria, amino aciduria)
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
- •Person and / or trustworthy person who has received complete information on the organization of the research and who has not opposed their participation and the use of their data
- •Hospitalized for ≥ 48 hours and ≤ 10 days
- •SARS-CoV-2 positive nasopharyngeal sample
- •Severity criteria: Lung involvement described as compatible with SARS-CoV-2 on radiography or scanner and partial pressure of oxygne (PaO2) / Fraction of inspired oxygen (FiO2) ≤ 300 mmHg and / or respiratory rate (RR) ≥ 30 / min
排除标准
- •Known chronic kidney disease, or initial Glomerular Filtration Rate (GFR) <60 ml / min / 1.73m2 or Renal Transplant
- •Known proteinuria
- •Known proximal tubulopathy
- •Treatment with Forxiga
结局指标
主要结局
SARS-CoV 2 viruria and its correlation with proximal tubule dysfunction
时间窗: During the first 10 days of hospitalization
Is the detection of viral particles in urine associated with proximal tubule dysfunction, defined by two or more of the following : proteinuria, phosphate leak, aminoaciduria, hyperuricuria, and/or glycosuria
次要结局
- Capacity of infection of urine viral particles(During the first 10 days of hospitalization)
- Sequencing viral particles to identify possible compartmentalization of the virus(During the first 10 days of hospitalization)
研究者
Raphaël KORMANN
Principal investigator, Medical Doctor, Nephrologist
Central Hospital, Nancy, France