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

• Sponsor: University Hospital, Montpellier (Other)
• Overall Status: Completed
• CT.gov ID: NCT04393428
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Actual Duration (Months): 4
• Patients Per Site Per Month: 25.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19; Renal Replacement Therapy; Acute Kidney Injury	Other: [TIMP-2]*[IGFBP-7]

Study Design

• Study Type: Observational
• Actual Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Urinary Biomarkers (TIMP-2 and IGFBP7) for Early Diagnostic Assessment of Acute Kidney Injury in Patients With SARS-CoV-2 (COVID-19)
• Actual Study Start Date: Mar 1, 2020
• Actual Primary Completion Date: Jun 1, 2020
• Actual Study Completion Date: Jun 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
COVID-19 patients with urinary samples COVID-19 patients with urinary samples	Other: [TIMP-2]*[IGFBP-7]; [TIMP-2]*[IGFBP-7] mesurement in urine sample relicates of COVID-19 patients admitted to the Montpellier University Hospital

Outcome Measures

Primary Outcome Measures

1. Sensibility and specificity of urinary [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 Outcome Measures

1. Sensibility and specificity of urinary [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Uhmontpellier	Montpellier		France	34295

Sponsors and Collaborators

• University Hospital, Montpellier

Investigators

• Principal Investigator: Romaric Larcher, MD, PharmD, MSc, UH Montpellier

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Montpellier
• ClinicalTrials.gov Identifier: NCT04393428
• Other Study ID Numbers: RECHMPL20_0294
• First Posted: May 19, 2020
• Last Update Posted: Jul 29, 2020
• Last Verified: Jul 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University Hospital, Montpellier: Acute Kidney Injury; SARS-CoV-2; Renal Replacement Therapy
• Additional relevant MeSH terms: COVID-19; Acute Kidney Injury

Study Results

No Results Posted as of Jul 29, 2020