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 — OTHERA 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 NegativeControl group to measure progression of AKI/kidney injury overtime
- Arm: COVID-19 PositiveStudy 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
- Minnie Sarwal, M.D., Ph.D.6503531532
- Tara Sigdel, PhD4155023561
Locations (3)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| UCSF | San Francisco | California | 94143 | Minnie Sarwal, MD, PhD BS Minnie Sarwal, MD, PhD (PRINCIPAL_INVESTIGATOR) |
| Rush University | Chicago | Illinois | 60612 | Jochen Reiser, MD, PhD (PRINCIPAL_INVESTIGATOR) |
| University of Michigan | Ann Arbor | Michigan | 48109 | Salim Hayek, MD (PRINCIPAL_INVESTIGATOR) |
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