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OpenTrials
Completed

NCT Number: NCT04393428

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

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.

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Key information

Conditions

COVID-19 Acute Kidney Injury Coronaviridae Infections Coronavirus Infections Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Kidney Diseases Lung Diseases Male Urogenital Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Renal Insufficiency Renal Replacement Therapy Respiratory Tract Diseases Respiratory Tract Infections Urogenital Diseases Urologic Diseases Virus Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Uhmontpellier

Montpellier, 34295, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

[TIMP-2]*[IGFBP-7]

Other

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

Primary outcomes

  1. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

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

Acronym: COVID-AKI

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 19, 2020
Registry last updated
Jul 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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