There is an unmet need to evaluate the impact of sub-clinical/mild COVID19 disease in theoutpatient setting on prevalent and incident renal injury, as this data is currentlyunavailable. To capture the diversity of race/ethnic risk and COVID19 related municipalshelter-in-place guidance, the investigators will enroll COVID19-negative andCOVID19-positive samples balanced by race/ethnicity from 3 different states, California,Michigan, and Illinois. Study endpoints will be assayed from urine samples mailed to thestudy team at 2, 6, and 12 months after their date of PCR test, with no requirement forthese individuals to leave their homes to participate.
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.
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.
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
UCSF
San Francisco, California, United States
Rush University
Chicago, Illinois, United States
University of Michigan
Ann Arbor, Michigan, United States
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