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KIDney Injury in Times of COVID-19 (KIDCOV) (KIDCOV)

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ClinicalTrials.gov Identifier: NCT04705766
Recruitment Status : Not yet recruiting
First Posted : January 12, 2021
Last Update Posted : February 12, 2021
Sponsor:
Collaborators:
Rush University Medical Center
University of Michigan
University of California
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
University of California, San Francisco

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.

Condition or disease Intervention/treatment
SARS-CoV Infection Covid19 Corona Virus Infection Acute Kidney Injury Kidney Injury Other: Urine Collection

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: The KIDCOV Study: ASSESSMENT of SARS-CoV-2 Without HOSPITALIZATION as a RISK FACTOR for ACUTE KIDNEY INJURY
Estimated Study Start Date : March 2021
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
COVID-19 Negative
Control group to measure progression of AKI/kidney injury overtime
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.

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
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 Outcome Measures :
  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 Outcome Measures :
  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).


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.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04705766


Contacts
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Contact: Tara Sigdel, Ph.D. 4155027921 tara.sigdel@ucsf.edu
Contact: Tariq Mukatash, B.A./B.S. 4155140192 tariq.mukatash@ucsf.edu

Locations
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United States, California
University of California
San Francisco, California, United States, 94143
Contact: Tara Sigdel, PhD    415-502-3561    tara.sigdel@ucsf.edu   
Contact: Tariq Mukatash, BA/BS    (415)514-0192    tariq.mukatash@ucsf.edu   
Principal Investigator: Minnie Sarwal, MD, PhD         
United States, Illinois
Rush University
Chicago, Illinois, United States, 60612
Contact: Beata Samelko    312-942-0143    beata_samelko@rush.edu   
Principal Investigator: Jochen Reiser, MD, PhD         
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Contact: Pennelope Kunkle    734-936-2813    penegonz@med.umich.edu   
Principal Investigator: Salim Hayek, MD         
Sponsors and Collaborators
University of California, San Francisco
Rush University Medical Center
University of Michigan
University of California
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Minnie Sarwal, M.D., Ph.D. University of California, San Francisco
Publications:
Caramelo, F., N. Ferreira, and B. Oliveiros, Estimation of risk factors for COVID-19 mortality - preliminary results. medRxiv, 2020: p. 2020.02.24.20027268.
Muus, C., et al., Integrated analyses of single-cell atlases reveal age, gender, and smoking status associations with cell type-specific expression of mediators of SARS-CoV-2 viral entry and highlights inflammatory programs in putative target cells. bioRxiv, 2020: p. 2020.04.19.049254.
Diao, B., et al., Human Kidney is a Target for Novel Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection. medRxiv, 2020: p. 2020.03.04.20031120.

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT04705766    
Other Study ID Numbers: KIDCOV2020
R01DK109720 ( U.S. NIH Grant/Contract )
First Posted: January 12, 2021    Key Record Dates
Last Update Posted: February 12, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Research records will be kept confidential to the extent permitted by law. Subjects will be identified by a code, and personal information from study records will not be released without the subject's permission. Study subjects will not be identified in any publication that may result from this study. However, the records may be reviewed under guidelines of the Federal Privacy Act by site monitors to assure the accuracy and completeness of study data. The investigators will make sure patient health information is removed from all the bio-samples and data obtained. The investigators will adhere to the NIH and HHS policies regarding the sharing of data and resources with the scientific community, publications, and intellectual property rights, and sharing of biomedical research resources.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of California, San Francisco:
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
Additional relevant MeSH terms:
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Coronavirus Infections
Infection
Communicable Diseases
Severe Acute Respiratory Syndrome
Acute Kidney Injury
Wounds and Injuries
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Respiratory Tract Infections
Respiratory Tract Diseases