Recruiting

KIDCOV

Sponsor:

UCLA

Code:

NCT04705766

Conditions

SARS-CoV Infection

Covid19

Corona Virus Infection

Acute Kidney Injury

Kidney Injury

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Urine Collection

Study Details

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.

Conditions

SARS-CoV Infection

Covid19

Corona Virus Infection

Acute Kidney Injury

Kidney Injury

Study ID

NCT04705766

Start date

Mar 1, 2021

Status verified date

Jul, 2025

Completion date

Mar, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

2000 participants

Anticipated

Interventions and Outcome Measures

Arms

COVID-19 Negative

Control group to measure progression of AKI/kidney injury overtime

COVID-19 Positive

Study group to assess AKI trajectory/progression and associated risk factors of kidney injury with SARS-CoV-2 infection

Interventions

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.

Primary outcome measure

  • Continuous, Quantitative KIT Score [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Minnie Sarwal, M.D., Ph.D.

6503531532minnie.sarwal@ucsf.edu

Tara Sigdel, PhD

4155023561tara.sigdel@ucsf.edu

Locations

UCSF

Recruiting

San Francisco, California, United States, 94143

Contacts

Minnie Sarwal, MD, PhD

minnie.sarwal@ucsf.edu

Principal Investigator:

Minnie Sarwal, MD, PhD

Rush University

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Beata Samelko

312-942-0143beata_samelko@rush.edu

Principal Investigator:

Jochen Reiser, MD, PhD

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Pennelope Kunkle

734-936-2813penegonz@med.umich.edu

Principal Investigator:

Salim Hayek, MD

More Information

Sponsor

University of California, San Francisco

Last update posted

Jul 28, 2025

Last verified

Jul, 2025

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2025-07-28.