Urinary Biomarkers for AKI Diagnosis in Patients With SARS-CoV-2 (COVID-19)

Overview

Among patients with SARS-CoV-2 pneumonia, approximately 20% have an acute kidney injury (AKI) and 5% require renal replacement therapy. Occurrence of AKI in patients with COVID-19 is associated with increased morbidity and mortality. Early detection of patients at risk of AKI would allow to prevent onset or worsening of AKI. The aim of this study is to determine if urine biomarkers of renal tubular damage such as TIMP-2 and IGFBP7 could early identify patients with SARS-CoV-2 pneumonia at risk of developing AKI.

Full Title of Study: “Urinary Biomarkers (TIMP-2 and IGFBP7) for Early Diagnostic Assessment of Acute Kidney Injury in Patients With SARS-CoV-2 (COVID-19)”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: June 1, 2020

Interventions

  • Other: [TIMP-2]*[IGFBP-7]
    • [TIMP-2]*[IGFBP-7] mesurement in urine sample relicates of COVID-19 patients admitted to the Montpellier University Hospital

Arms, Groups and Cohorts

  • COVID-19 patients with urinary samples
    • COVID-19 patients with urinary samples

Clinical Trial Outcome Measures

Primary Measures

  • Sensibility and specificity of urinary
    • Time Frame: Occurence of AKI 7 days after urinary biomarkers measurement
    • Sensibility and specificity of urinary [TIMP-2]*[IGFBP-7] > 0,3 to predict AKI (KDIGO stage ≥ 1) in SARS-CoV-2 patients at day-7 after measurement

Secondary Measures

  • Sensibility and specificity of urinary
    • Time Frame: Occurnce of AKI worsening, renal replacement therapy requirement or persistant AKI, 7 days after urinary biomarkers mesurement
    • Sensibility and specificity of urinary [TIMP-2]*[IGFBP-7] > 0,3 to predict AKI worsening, renal replacement therapy requirement or persistant AKI

Participating in This Clinical Trial

Inclusion Criteria

  • Age ≥ 18 years – COVID-19 confirmed by positive SARS-CoV-2 PCR – at least one urine sample Exclusion criteria:

  • Persons under protection – Paritcipation rejections

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 100 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Montpellier
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Romaric Larcher, MD, PharmD, MSc, Principal Investigator, UH Montpellier

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