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COVID-19 Negative for Acute Kidney Injury (KIDCOV Trial)

N/A
Recruiting
Led By Minnie Sarwal, M.D., Ph.D.
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

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.

Eligible Conditions
  • Acute Kidney Injury
  • Coronavirus
  • Kidney Injury

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Continuous, Quantitative KIT Score
Secondary study objectives
Number of participants with a level of Kidney Injury Molecule-1 (KIM1) above 1 ng/ml
Number of participants with a level of Neutrophil Gelatinase-Associated Lipocalin (NGAL) above 1 ng/ml
Number of participants with a level of soluble urokinase-type plasminogen activator receptor (suPAR) above 1 ng/ml

Side effects data

From 2015 Phase 4 trial • 15 Patients • NCT01380366
7%
Hospitalization for Escherichia coli Infection
7%
Hospitalization for Gram-positive Cocci
7%
Hospitalization for positive line infection
7%
Pancreatitis
7%
Hospitalization for abdominal pain (pre-treatment)
7%
Hospitalization for Flu like Symptoms
100%
80%
60%
40%
20%
0%
Study treatment Arm
Patients Consented to be Given rHGH

Trial Design

2Treatment groups
Experimental Treatment
Group I: COVID-19 PositiveExperimental Treatment1 Intervention
Study group to assess AKI trajectory/progression and associated risk factors of kidney injury with SARS-CoV-2 infection
Group II: COVID-19 NegativeExperimental Treatment1 Intervention
Control group to measure progression of AKI/kidney injury overtime

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor
2,551 Previous Clinical Trials
15,255,886 Total Patients Enrolled
7 Trials studying Acute Kidney Injury
1,527 Patients Enrolled for Acute Kidney Injury
Rush University Medical CenterOTHER
431 Previous Clinical Trials
156,401 Total Patients Enrolled
University of MichiganOTHER
1,833 Previous Clinical Trials
6,421,128 Total Patients Enrolled
11 Trials studying Acute Kidney Injury
10,965 Patients Enrolled for Acute Kidney Injury
~567 spots leftby Mar 2026
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