KIDney Injury in Times of COVID-19 (KIDCOV)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of California, San Francisco
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Urine Collection
Other interventionA 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.
Treatment groups
2,000 Participants
are divided into 2 treatment groupsGroup A: COVID-19 Negative1 intervention
Group B: COVID-19 Positive1 intervention
Trial outcomes
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.
Time frame
1 yearSecondary outcomes
1
Number of participants with a level of Kidney Injury Molecule-1 (KIM1) above 1 ng/ml
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).
Time frame
1 year2
Number of participants with a level of Neutrophil Gelatinase-Associated Lipocalin (NGAL) above 1 ng/ml
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).
Time frame
1 year3
Number of participants with a level of soluble urokinase-type plasminogen activator receptor (suPAR) above 1 ng/ml
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).
Time frame
1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of California, San Francisco
Lead sponsor
Rush University Medical Center
Collaborator
University of Michigan
Collaborator
University of California
Collaborator
Source ClinicalTrials.gov