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NCT Number: NCT04705766

KIDney Injury in Times of COVID-19 (KIDCOV)

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

  2. 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).

  3. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

6503531532

Tara Sigdel, PhD

CONTACT

[email protected]

4155023561

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Rush University Medical Center
  • University of California
  • University of Michigan

Registry information

Official study title

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

Acronym: KIDCOV

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Jan 12, 2021
Registry last updated
Jul 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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