The KIDCOV Study: Assessment of Kidney Injury and Associated Risk Factors for SARS-CoV-2
KIDCOV 研究:评估 SARS-CoV-2 肾损伤及相关风险因素
基本信息
- 批准号:10216618
- 负责人:
- 金额:$ 45.96万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2017
- 资助国家:美国
- 起止时间:2017-04-01 至 2022-03-31
- 项目状态:已结题
- 来源:
- 关键词:2019-nCoVAcademic Medical CentersAcuteAcute Kidney FailureAcute Renal Failure with Renal Papillary NecrosisAddressAfrican AmericanAlaska NativeAmerican IndiansAsiansAssesBackBiological AssayBiological MarkersBlood TestsCOVID-19COVID-19 pandemicCXCL10 geneCaliforniaCellsClinicalCohort StudiesCollectionCommunitiesComputerized Medical RecordConsentCreatinineCustomDNADNA MethylationDataData AnalysesData Coordinating CenterDemographic FactorsDetectionDiagnosisDiseaseElectronic Health RecordEnrollmentEthnic OriginEvolutionFocal Segmental GlomerulosclerosisGeographyHealth StatusHigh PrevalenceHome environmentHumanIllinoisIncidenceIndividualInfectionInjury to KidneyIslandKidneyKidney DiseasesLCN2 geneLow PrevalenceMichiganMinorityMulticenter StudiesNative HawaiianNeedlesOutpatientsParentsParticipantPatientsPeptidyl-Dipeptidase APhasePopulationPopulation DensityPrevalenceProspective StudiesProspective cohortProteinsProteinuriaPublishingQuestionnairesRaceRecording of previous eventsRenal tubule structureReportingResearchResearch DesignRiskRisk FactorsRunningSamplingSerumShipsSiteSocial DistanceSpecific qualifier valueSterilitySymptomsTelephoneTemperatureTest ResultTestingTimeTissuesUniversitiesUrineVariantVirusVirus Diseasesbasecell free DNAcohortcomorbiditycoronavirus diseasecytokine release syndromedemographicsepidemiologic dataethnic diversityfollow-uphigh riskinfection riskinnovative technologiesnovelprospectivereceptorrenal damagescreeningstandard of caresulfated glycoprotein 2urinaryviral RNA
项目摘要
ABSTRACT
From early studies and published reports indicate kidney injury is one of the manifestations of COVID-19. The
human kidney is a direct target of the virus, as the angiotensin-converting enzyme 2 (ACE2), a putative receptor
for SARS-CoV-2, is highly expressed in the kidney tubules. As direct evidence of the virus localizing to the kidney,
SARS-CoV-2 viral RNA can be observed in urine and kidney tissue from patients with COVID-19. Kidney injury
can result in acute kidney injury in ~60% of hospitalized patients. The incidence, prevalence and risk factors
of kidney injury in patients with mild/ asymptomatic out-patient COVID-19 disease is as yet unknown. This
forms a large cohort of SARS-CoV-2 infected patients in the community world-wide.
We propose in this supplement to the parent RO1 that examines suPAR and other circulating factors in FSGS
disease, that urinary suPAR and other urine biomarkers that comprise a novel highly sensitive and quantitative
assay (the Kidney Injury Test), can provide an assessment of the incidence and prevalence of kidney damage
in COVID-19 by home-based urine testing, independent of any blood test requirement. In this study, we
are hypothesizing that risk of kidney injury in COVID-19 disease, also varies by race/ethnicity and other
demographic factors, is exacerbated by COVID-19 infection, and is more severe in those with a history of or risk
factors of kidney disease. We have made careful selection of 7 large academic medical center study sites, in
3 states, to address these questions in the KIDCOV prospective, multi-center study.
To test the hypothesis and to achieve the aim of the KIDCOV project, we will perform the study in three stages:.
In the first stage, we will enroll outpatient COVID-19 positive patients. COVID-19 positive patients will be enrolled
from academic medical centers in California (University of California, 5 campuses), Michigan (University of
Michigan) and Illinois (Rush University). Prospective matched cohorts of COVID positive and COVID negative
individuals, balanced by race/ethnicity, will be identified through EMRs and contacted by phone within 2 weeks of
screening to provide consent and complete a baseline questionnaire.
In the second stage, over the following 12 months, urine samples will be collected and shipped for the assessment
of specific urinary markers at UCSF central lab (cell-free DNA (cfDNA), methylation of cell-free DNA (mcf-DNA),
clusterin, CXCL10, protein and creatinine) to compute a validated Kidney Injury Test (KIT)-Score for sensitive
assessment of early kidney damage. Acute kidney injury markers, NGAL, KIM-1 and suPAR will also be
quantitated in urine as correlates of kidney damage with the KIT-Score.
In the final phase, data analysis will be done to compare the proportion of patients with kidney injury between the
COVID-19 positive and COVID-19 negative groups and identify groups at higher risk for kidney injury, with primary
focus on COVID19 status, history/risk factors of prior kidney disease, and geographic, demographic and ethnic
variation.
摘要
早期研究和已发表的报告表明,肾损伤是COVID-19的表现之一。的
人肾脏是病毒的直接靶点,因为血管紧张素转换酶2(ACE 2)是一种假定的受体
SARS-CoV-2在肾小管中高度表达。作为病毒定位于肾脏的直接证据,
在COVID-19患者的尿液和肾组织中可以观察到SARS-CoV-2病毒RNA。肾损伤
可导致约60%的住院患者发生急性肾损伤。发病率、患病率和危险因素
目前尚不清楚轻度/无症状门诊COVID-19疾病患者的肾损伤情况。这
在世界范围内的社区中形成了一个大的SARS-CoV-2感染患者队列。
我们建议在本补充的父RO 1,检查suPAR和其他循环因子在FSGS
疾病、尿suPAR和其它尿生物标志物,其包括新高度敏感和定量的
肾损伤试验(Kidney Injury Test)可以评估肾损伤的发生率和患病率
在COVID-19通过家庭尿液检测,独立于任何血液检测要求。本研究
假设COVID-19疾病中肾损伤的风险也因种族/民族和其他因素而异,
人口因素,因COVID-19感染而加重,在有COVID-19病史或风险的人群中更为严重
肾脏疾病的因素。我们精心挑选了7个大型学术医疗中心的研究地点,
在KIDCOV前瞻性多中心研究中解决这些问题。
为了验证假设并实现KIDCOV项目的目标,我们将分三个阶段进行研究:
在第一阶段,我们将招募门诊COVID-19阳性患者。COVID-19阳性患者将入组
来自加州(加州大学,5个校区)、密歇根大学(密歇根大学,
密歇根州)和伊利诺伊州(拉什大学)。COVID阳性和COVID阴性的前瞻性匹配队列
将通过EMR识别受试者(按种族/民族平衡),并在2周内通过电话联系
筛选以提供知情同意并完成基线问卷。
在第二阶段,在接下来的12个月内,将收集并运送尿液样本进行评估
在UCSF中心实验室的特定尿液标志物(无细胞DNA(cfDNA),无细胞DNA的甲基化(mcf-DNA),
clusterin、CXCL 10、蛋白质和肌酸酐)来计算经验证的肾损伤测试(KIT)-敏感性肾损伤的评分。
评估早期肾损伤。急性肾损伤标志物NGAL、KIM-1和suPAR也将被检测。
在尿中定量,作为肾损伤与KIT评分的相关性。
在最后阶段,将进行数据分析,以比较
COVID-19阳性和COVID-19阴性人群,并识别肾损伤风险较高的人群,
重点关注COVID 19状态、既往肾脏疾病史/风险因素以及地理、人口统计学和种族
变化量
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
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Jochen Reiser其他文献
Jochen Reiser的其他文献
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{{ truncateString('Jochen Reiser', 18)}}的其他基金
Role of proteolytic suPAR fragment in insulin dependent diabetes and kidney disease
蛋白水解suPAR片段在胰岛素依赖性糖尿病和肾脏疾病中的作用
- 批准号:
10654224 - 财政年份:2023
- 资助金额:
$ 45.96万 - 项目类别:
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