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

July 28, 2020 updated by: University Hospital, Montpellier

Urinary Biomarkers (TIMP-2 and IGFBP7) for Early Diagnostic Assessment of Acute Kidney Injury 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34295
        • Uhmontpellier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Occurence of AKI 7 days after urinary biomarkers measurement

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Occurnce of AKI worsening, renal replacement therapy requirement or persistant AKI, 7 days after urinary biomarkers mesurement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2020

Primary Completion (ACTUAL)

June 1, 2020

Study Completion (ACTUAL)

June 30, 2020

Study Registration Dates

First Submitted

May 14, 2020

First Submitted That Met QC Criteria

May 14, 2020

First Posted (ACTUAL)

May 19, 2020

Study Record Updates

Last Update Posted (ACTUAL)

July 29, 2020

Last Update Submitted That Met QC Criteria

July 28, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RECHMPL20_0294

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

NC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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