KIDney Injury in Times of COVID-19 (KIDCOV)

Covid19 Clinical Trial

— KIDCOV  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04705766
• Other study ID #: KIDCOV2020
• Status: Recruiting
• Start date: March 1, 2021
• Est. completion date: March 2026

Study information

• Verified date: March 2024
• Source: University of California, San Francisco
• Contact: Minnie Sarwal, M.D., Ph.D.
• Phone: 6503531532
• Email: minnie.sarwal[@]ucsf.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: March 2026
• Est. primary completion date: March 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Communicable Diseases
• Corona Virus Infection
• Coronavirus Infections
• COVID-19
• Covid19
• Infections
• Kidney Injury
• SARS-CoV Infection
• Severe Acute Respiratory Syndrome
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Rush University	Chicago	Illinois
United States	UCSF	San Francisco	California

Sponsors (4)

Lead Sponsor	Collaborator
University of California, San Francisco	Rush University Medical Center, University of California, University of Michigan

Country where clinical trial is conducted

United States, 

References & Publications (32)

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* Note: There are 32 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).	1 year
Secondary	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).	1 year
Secondary	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).	1 year