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

COVID-19 Clinical Trial

— COVID-AKI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04393428
• Other study ID #: RECHMPL20_0294
• Status: Completed
• Start date: March 1, 2020
• Est. completion date: June 30, 2020

Study information

• Verified date: July 2020
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 30, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• COVID-19
• Renal Replacement Therapy

Intervention

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

Locations

Country	Name	City	State
France	Uhmontpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Sensibility and specificity of urinary	Sensibility and specificity of urinary [TIMP-2]*[IGFBP-7] > 0,3 to predict AKI worsening, renal replacement therapy requirement or persistant AKI	Occurnce of AKI worsening, renal replacement therapy requirement or persistant AKI, 7 days after urinary biomarkers mesurement