KIDney Injury in Times of COVID-19 (KIDCOV) (KIDCOV)

July 24, 2025 updated by: University of California, San Francisco

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • Recruiting
        • UCSF
        • Contact:
          • BS
        • Principal Investigator:
          • Minnie Sarwal, MD, PhD
        • Contact:
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • Rush University
        • Contact:
        • Principal Investigator:
          • Jochen Reiser, MD, PhD
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan
        • Principal Investigator:
          • Salim Hayek, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Individuals with current SARS-CoV-2 test result recorded in their electronic medical record (EMR) at a participating Academic Medical Center (AMC). EMR must also record: contact information (for inviting participation and mailing urine kits), age (to confirm 18+ years), race and sex (to balance COVID- vs. COVID+ samples), current serum creatinine (an outcome), history of kidney transplant or dialysis (ineligible), and hospitalization up to 4 weeks after SARS-CoV-2 test (ineligible).

By restricting eligibility to individuals not hospitalized within the month after their PCR test, the investigators study people at low risk of kidney injury, as the investigators survey a population of otherwise well people. This reflects the public health goal: To estimate excess risk of kidney injury among the >80% of COVID19-infected individuals in whom the infection resolves without intensive healthcare intervention, in order to unveil an otherwise silent health burden on society.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
COVID-19 Negative
Control group to measure progression of AKI/kidney injury overtime
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.
COVID-19 Positive
Study group to assess AKI trajectory/progression and associated risk factors of kidney injury with SARS-CoV-2 infection
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Continuous, Quantitative KIT Score
Time Frame: 1 year
The 12-month continuous, quantitative Kidney Injury Test (KIT) score, measured on a scale of 0-100, where a higher urine-based KIT score correlates to worse kidney injury.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with a level of Kidney Injury Molecule-1 (KIM1) above 1 ng/ml
Time Frame: 1 year
Number of participants with a level of Kidney Injury Molecule-1 (KIM1) above 1 ng/ml, indicating the presence of kidney injury (higher value indicates worse kidney injury).
1 year
Number of participants with a level of Neutrophil Gelatinase-Associated Lipocalin (NGAL) above 1 ng/ml
Time Frame: 1 year
Number of participants with a level of Neutrophil Gelatinase-Associated Lipocalin (NGAL) above 1 ng/ml, indicating the presence of kidney injury (higher value indicates worse kidney injury).
1 year
Number of participants with a level of soluble urokinase-type plasminogen activator receptor (suPAR) above 1 ng/ml
Time Frame: 1 year
Number of participants with a level of soluble urokinase-type plasminogen activator receptor (suPAR), indicating the presence of kidney injury (higher value indicates worse kidney injury).
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

University of Michigan
Rush University Medical Center
University of California

Investigators

  • Principal Investigator: Minnie Sarwal, M.D., Ph.D., University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2021

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

December 16, 2020

First Submitted That Met QC Criteria

January 11, 2021

First Posted (Actual)

January 12, 2021

Study Record Updates

Last Update Posted (Actual)

July 28, 2025

Last Update Submitted That Met QC Criteria

July 24, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KIDCOV2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Research records will be kept confidential to the extent permitted by law. Subjects will be identified by a code, and personal information from study records will not be released without the subject's permission. Study subjects will not be identified in any publication that may result from this study. However, the records may be reviewed under guidelines of the Federal Privacy Act by site monitors to assure the accuracy and completeness of study data. The investigators will make sure patient health information is removed from all the bio-samples and data obtained. The investigators will adhere to the NIH and HHS policies regarding the sharing of data and resources with the scientific community, publications, and intellectual property rights, and sharing of biomedical research resources.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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