Clinical trial NCT04705766: KIDney Injury in Times of COVID-19 (KIDCOV)
Official title: The KIDCOV Study: ASSESSMENT of SARS-CoV-2 Without HOSPITALIZATION as a RISK FACTOR for ACUTE KIDNEY INJURY
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Rush University Medical Center
name: University of Michigan
name: University of California
First posted: 2021-01-12
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Continuous, Quantitative KIT Score
timeFrame: 1 year
Secondary outcomes:
measure: Number of participants with a level of Kidney Injury Molecule-1 (KIM1) above 1 ng/ml
timeFrame: 1 year
measure: Number of participants with a level of Neutrophil Gelatinase-Associated Lipocalin (NGAL) above 1 ng/ml
timeFrame: 1 year
measure: Number of participants with a level of soluble urokinase-type plasminogen activator receptor (suPAR) above 1 ng/ml
timeFrame: 1 year
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF
state: California
city: Chicago
country: United States
facility: Rush University
state: Illinois
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of California, San Francisco
name: Minnie Sarwal, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
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