KIDney Injury in Times of COVID-19 (KIDCOV)

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT04705766
Status
Recruiting

Conditions

  • Acute Kidney Injury
  • Corona Virus Infection
  • Covid19
  • Kidney Injury
  • SARS-CoV Infection

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Urine Collection — OTHER
    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.

Study Details

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.

Key Dates

Start date
Mar 1, 2021
Status verified
Jul 2025
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
2,000 participants (estimated)

Arms

  • Arm: COVID-19 Negative
    Control group to measure progression of AKI/kidney injury overtime
  • Arm: COVID-19 Positive
    Study group to assess AKI trajectory/progression and associated risk factors of kidney injury with SARS-CoV-2 infection

Primary Outcome Measure

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

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
UCSFSan FranciscoCalifornia94143
Minnie Sarwal, MD, PhD
BS
Minnie Sarwal, MD, PhD (PRINCIPAL_INVESTIGATOR)
Rush UniversityChicagoIllinois60612
Beata Samelko
312-942-0143
Jochen Reiser, MD, PhD (PRINCIPAL_INVESTIGATOR)
University of MichiganAnn ArborMichigan48109
Pennelope Kunkle
734-936-2813
Salim Hayek, MD (PRINCIPAL_INVESTIGATOR)

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