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

NCT04393428 | Completed

• 1 other identifier: RECHMPL20_0294
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19; Renal Replacement Therapy; Acute Kidney Injury

Keywords

Acute Kidney Injury; SARS-CoV-2; Renal Replacement Therapy

Outcome Measures

Primary Outcomes (1)

• Sensibility and specificity of urinary

  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

  Occurence of AKI 7 days after urinary biomarkers measurement

Secondary Outcomes (1)

• Sensibility and specificity of urinary

  Occurnce of AKI worsening, renal replacement therapy requirement or persistant AKI, 7 days after urinary biomarkers mesurement

Study Arms (1)

COVID-19 patients with urinary samples

COVID-19 patients with urinary samples

Other: [TIMP-2]*[IGFBP-7]

Interventions

[TIMP-2]*[IGFBP-7] OTHER

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

COVID-19 patients with urinary samples

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

COVID-19 patients admitted to the Montpellier University Hospital with at least one rine sample drawn

You may qualify if:

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

You may not qualify if:

• Persons under protection
• Paritcipation rejections

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

NC

MeSH Terms

Conditions

COVID-19; Acute Kidney Injury

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Romaric Larcher, MD, PharmD, MSc

  UH Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2020
• First Posted: May 19, 2020
• Study Start: March 1, 2020
• Primary Completion: June 1, 2020
• Study Completion: June 30, 2020
• Last Updated: July 29, 2020

Record last verified: 2020-07

Locations

FR (1)