# The KIDCOV Study: Assessment of Kidney Injury and Associated Risk Factors for SARS-CoV-2

> **NIH NIH R01** · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · 2020 · $459,623

## Abstract

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 fac...

## Key facts

- **NIH application ID:** 10216618
- **Project number:** 3R01DK109720-04S1
- **Recipient organization:** UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
- **Principal Investigator:** Jochen Reiser
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $459,623
- **Award type:** 3
- **Project period:** 2017-04-01 → 2022-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10216618

## Citation

> US National Institutes of Health, RePORTER application 10216618, The KIDCOV Study: Assessment of Kidney Injury and Associated Risk Factors for SARS-CoV-2 (3R01DK109720-04S1). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10216618. Licensed CC0.

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