KIDney Injury in Times of COVID-19 (KIDCOV)

NCT04705766 | Recruiting DMC

• 1 other identifier: KIDCOV2020
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 3

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

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

Outcome Measures

Primary Outcomes (1)

• Continuous, Quantitative KIT Score

  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 Outcomes (3)

• Number of participants with a level of Kidney Injury Molecule-1 (KIM1) above 1 ng/ml

  1 year

• Number of participants with a level of Neutrophil Gelatinase-Associated Lipocalin (NGAL) above 1 ng/ml

  1 year

• Number of participants with a level of soluble urokinase-type plasminogen activator receptor (suPAR) above 1 ng/ml

  1 year

Study Arms (2)

COVID-19 Negative

Control group to measure progression of AKI/kidney injury overtime

Other: Urine Collection

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

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.

COVID-19 Negative; COVID-19 Positive

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• Rush University Medical Center: collaborator
• University of Michigan: collaborator
• University of California: collaborator

Study Sites (3)

UCSF

San Francisco, California, 94143, United States

RECRUITING

Rush University

Chicago, Illinois, 60612, United States

RECRUITING

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

Related Publications (32)

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  BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Participation will involve completion of questionnaires with return of urine samples in mailed collection kits at 2, 6, and 12 months after their date of PCR test.

MeSH Terms

Conditions

Severe Acute Respiratory Syndrome; COVID-19; Coronavirus Infections; Acute Kidney Injury

Interventions

Urine Specimen Collection

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Minnie Sarwal, M.D., Ph.D.

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

6503531532; minnie.sarwal@ucsf.edu

Tara Sigdel, PhD

CONTACT

4155023561; tara.sigdel@ucsf.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2020
• First Posted: January 12, 2021
• Study Start: March 1, 2021
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)