Document text
Principal Investigator: Jochen Reiser
Organization: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
Fiscal Year: 2020
Award: $459,623
Funding agency: National Institute of Diabetes and Digestive and Kidney Diseases
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.
Terms: <2019 novel coronavirus><2019-nCoV><Academic Medical Centers><Active Follow-up><Acute><Acute Kidney Failure><Acute Kidney Insufficiency><Acute Renal Failure><Acute Renal Failure with Renal Papillary Necrosis><Acute Renal Insufficiency><Address><African American><Afro American><Afroamerican><Alaska Indian><Alaska Native><Alaskan American><Alaskan Indian><Alaskan Native><Alaskan Native American><American Indian><American Indians><Angiotensin Converting Enzyme><Angiotensin I-Converting Enzyme><Asians><Assay><Asses><Back><Bioassay><Biologic Assays><Biological Assay><Biological Markers><Black Populations><Blood Serum><Blood Tests><Body Tissues><CD143 Antigens><COVID><COVID-19><COVID-19 epidemic><COVID-19 pandemic><COVID19><COVID19 epidemic><COVID19 pandemic><CRG-2><CXCL10><CXCL10 gene><California><Carboxycathepsin><Cell Body><Cells><Clinical><CoV disease><Cohort Studies><Collection><Communities><Computerized Medical Record><Concurrent Studies><Consent><Creatinine><Custom><DNA><DNA Methylation><Data><Data Analyses><Data Analysis><Data Coordinating Center><Data Coordination Center><Demographic Factors><Deoxyribonucleic Acid><Detection><Diagnosis><Dipeptidyl Peptidase A><Disease><Disorder><Donkey><Dorsum><Electronic Health Record><Electronic Medical Record><Enrollment><Epidemiological data><Epidemiology data><Equus asinus><Ethnic Origin><Ethnicity><Evolution><FSGS><Focal Segmental Glomerulosclerosis><Focal segmental glomerular sclerosis><Geography><Health Status><Hematologic Tests><Hematological Tests><Hematology Testing><High Prevalence><History><Home><Home environment><Human><IFI10><INP10><IP-10><Illinois><Incidence><Individual><Infection><Injury to Kidney><Island><Kidney><Kidney Diseases><Kidney Tubules><Kidney Urinary System><Kininase A><Kininase II><LCN2><LCN2 gene><Level of Health><Lipocalin 2><Low Prevalence><MAC393 antigen><MOB-1><Michigan><Minority><Modern Man><Multi-center studies><Multicenter Studies><NGAL><Native Hawaiian><Needles><Nephropathy><Neutrophil Gelatinase-Associated Lipocalin><Oncogenic Lipocalin 24P3><Out-patients><Outpatients><Parents><Participant><Patients><Peptidyl-Dipeptidase A><Phase><Phone><Population><Population Density><Prevalence><Prospective Studies><Prospective cohort><Proteins><Proteinuria><Publishing><Questionnaires><Race><Racial Group><Racial Stocks><Receptor Protein><Recording of previous events><Renal Disease><Renal tubule structure><Reporting><Research><Research Design><Risk><Risk Factors><Running><SARS-CoV-2><SARS-CoV2><SARS-associated coronavirus 2><SARS-coronavirus-2><SARS-related coronavirus 2><SCYB10><SGP-2 protein><SGP2><SP 40,40 protein><Sampling><Serum><Severe acute respiratory syndrome coronavirus 2><Ships><Site><Social Distance><Specific qualifier value><Specified><Sterility><Study Type><Symptoms><TRPM-2 protein><TRPM2><Telephone><Temperature><Test Result><Testing><Time><Tissues><Universities><University Medical Centers><Urine><Urine Urinary System><Uterocalin><Variant><Variation><Viral Diseases><Virus><Virus Diseases><Wuhan coronavirus><X-ray-inducible protein 8><XIP8 protein><active followup><acute kidney injury><apoJ protein><apolipoprotein J><base><bio-markers><biologic marker><biomarker><black American><cell free DNA><cell free circulating DNA><clusterin><co-morbid><co-morbidity><cohort><comorbidity><complement lysis inhibitor><complement-associated protein SP-40,40 protein><corona virus disease><corona virus disease 2019><corona virus disease 2019 epidemic><corona virus disease 2019 pandemic><coronavirus disease><coronavirus disease 2019><coronavirus disease 2019 epidemic><coronavirus disease 2019 pandemic><cytokine release syndrome><cytokine storm><damage to kidney><data interpretation><demographics><electronic health care record><electronic healthcare record><enroll><epidemiologic data><ethnic diversity><ethnically diverse><follow up><follow-up><followed up><followup><gIP-10><high risk><infection risk><innovative technologies><ionizing radiation-induced protein-8><kidney damage><kidney disorder><kidney injury><novel><oriental><prospective><receptor><renal><renal damage><renal disorder><renal injury><renal tubule><screening><standard of care><sterile><study design><sulfated glycoprotein 2><testosterone-repressed prostate message-2 protein><urinary><viral RNA><viral infection><virus RNA><virus infection><virus-induced disease>