Official Title
The KIDCOV Study: ASSESSMENT of SARS-CoV-2 Without HOSPITALIZATION as a RISK FACTOR for ACUTE KIDNEY INJURY
Brief Summary

There is an unmet need to evaluate the impact of sub-clinical/mild COVID19 disease in the outpatient setting on prevalent and incident renal injury, as this data is currently unavailable. To capture the diversity of race/ethnic risk and COVID19 related municipal shelter-in-place guidance, the investigators will enroll COVID19-negative and COVID19-positive samples balanced by race/ethnicity from 3 different states, California, Michigan, and Illinois. Study endpoints will be assayed from urine samples mailed to the study team at 2, 6, and 12 months after their date of PCR test, with no requirement for these individuals to leave their homes to participate.

Detailed Description

KIDCOV is a longitudinal cohort study that will prospectively follow cohorts of
COVID19-negative and COVID19-positive adults for episodes of kidney injury over a 12-months
period. Study candidates will be identified via site-specific electronic medical records
(EMR) at seven academic medical centers in the U.S. within 4 weeks of a PCR-based test for
SARS-Cov2. Screen-positive individuals will be contacted by email or text and invited to
complete an online consent form documenting their willingness to participate. Participation
will involve completion of questionnaires and return of urine samples in mailed collection
kits at 2, 6, and 12 months after their date of PCR test. The primary endpoint will be the
urine-based KIT Score, based on the composite measurement of multiple DNA, protein and
metabolite urinary biomarkers (reference). Secondary endpoints include NGAL and KIM-1 urinary
biomarkers for kidney injury assessment.

Early detection of new or worsening kidney injury is urgently needed in order to implement
preventative measures and target therapeutics that can minimize excess post-COVID19 kidney
damage. A complete and standardized understanding of the trajectory and risk factors for
kidney injury associated with COVID19+ disease is critical to informing the design and
implementation of preventative and therapeutic strategies for COVID19-mediated kidney injury.

Recruiting
SARS-CoV Infection
COVID19
Corona Virus Infection
Acute Kidney Injury
Kidney Injury

Other: Urine Collection

A urine collection kit will be mailed to subjects' residence at 3 different timepoints over the course of 1 year to be returned to study team, upon which KIT score and other biomarkers will be assessed as outlined in the study design.

Eligibility Criteria

Inclusion Criteria:

- Result of PCR-based COVID-19 test conducted in the past 4 weeks posted in EMR of
participating AMC

- Age 18 years or older at enrollment

- Race/ethnicity, sex, age, and phone and/or home/email address provided

Exclusion Criteria:

- Failure of a candidate participant to give written informed consent to comply with the
study protocol

- Hospitalization up to 4 weeks after SARS-CoV-2 test

- History of kidney transplant

- History of dialysis

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
United States
Locations

UCSF
San Francisco, California, United States

Rush University
Chicago, Illinois, United States

University of Michigan
Ann Arbor, Michigan, United States

Contacts

Minnie Sarwal, M.D., Ph.D.
6503531532
minnie.sarwal@ucsf.edu

Tara Sigdel, PhD
4155023561
tara.sigdel@ucsf.edu

Minnie Sarwal, M.D., Ph.D., Principal Investigator
University of California, San Francisco

University of California, San Francisco
NCT Number
Keywords
SARS-CoV-2
Acute Kidney Injury
Covid-19
Coronaviurs
COVID-19 infection
SARS-CoV-2 infection
Coronavirus infection
COVID-19 and Acute Kidney Injury
SARS-CoV-2 & Kidney Injury Risk Factors
Kidney Injury
MeSH Terms
Infections
Communicable Diseases
COVID-19
Coronavirus Infections
Severe Acute Respiratory Syndrome
Acute Kidney Injury
Wounds and Injuries