Summary

Eligibility
for people ages 18 years and up (full criteria)
Healthy Volunteers
healthy people welcome
Location
at San Francisco, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Minnie Sarwal, M.D., Ph.D.
Photo of Minnie Sarwal
Minnie Sarwal

Description

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.

Official Title

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

Details

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.

Keywords

SARS-CoV Infection Covid19 Corona Virus Infection Acute Kidney Injury Kidney Injury SARS-CoV-2 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 Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Wounds and Injuries Urine Collection COVID-19 Negative COVID-19 Positive

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • University of California accepting new patients
    San Francisco California 94143 United States
  • Rush University accepting new patients
    Chicago Illinois 60612 United States

Lead Scientist at UCSF

  • Minnie Sarwal, M.D., Ph.D.
    Professor in Residence, Surgery, Division of MultiOrgan Transplantation, UCSF Medical Director (interim), Kidney-Pancreas Transplant Program, UCSF Capstone Mentor, Masters in Translational Medicine, Berkeley/UCSF Consulting Professor, Haas, University of California, Berkeley Professor, Immunology, Peds, Surgery (1997-2012), Stanford University Medical Director (2008-2012), Ped…

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT04705766
Study Type
Observational [Patient Registry]
Last Updated