Analysis of SARS-CoV2 Urine Viral Particles and Association With Proximal Tubular Dysfunction (CovUrinePTD)

Molecular Characterization and Cellular Infection Capacity of Urinary Viral Particles Isolated From SARS-CoV-2 and Association With Proximal Tubular Dysfunction, in Hospitalized Patients With COVID-19

The primary goal is to detect Severe Acute Respiratory Syndrome CoronaVirus 2 (SARS-CoV2) urine viral particles in patients in intensive care units, hospitalized for coronavirus Coronavirus Disease-19 (COVID-19) infection, and correlate the presence of the virus in the urine with proximal tubular dysfunction (defined by the association of at least 2 abnormalities: tubular proteinuria, renal phosphate leak, uricosuria, normoglycemic glycosuria, amino aciduria)

Study Overview

• Status: Recruiting
• Conditions: SARS-CoV2 Infection; Proximal Tubule Dysfunction
• Intervention / Treatment: Other: RT-PCR SARS-COV2 in urine

• Study Type: Observational
• Enrollment (Anticipated): 34

Contacts and Locations

• Study Contact: Name: Raphaël Kormann; Phone Number: +33383155533; Email: r.kormann@chru-nancy.fr

Study Locations

• France
  • Nancy, France, 54000
    • Recruiting
    • CHRU Brabois
    • Contact: Raphaël Kormann, MD PhD; Phone Number: 0033383155533; Email: r.kormann@chru-nancy.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients hospitalized in CHRU Nancy with severe SARS-CoV2 infection, with lung involvement.

Description

Inclusion Criteria:

• Person and / or trustworthy person who has received complete information on the organization of the research and who has not opposed their participation and the use of their data
• Hospitalized for ≥ 48 hours and ≤ 10 days
• SARS-CoV-2 positive nasopharyngeal sample
• Severity criteria: Lung involvement described as compatible with SARS-CoV-2 on radiography or scanner and partial pressure of oxygne (PaO2) / Fraction of inspired oxygen (FiO2) ≤ 300 mmHg and / or respiratory rate (RR) ≥ 30 / min

Exclusion Criteria:

• Known chronic kidney disease, or initial Glomerular Filtration Rate (GFR) <60 ml / min / 1.73m2 or Renal Transplant
• Known proteinuria
• Known proximal tubulopathy
• Treatment with Forxiga

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SARS-CoV 2 viruria and its correlation with proximal tubule dysfunction	Is the detection of viral particles in urine associated with proximal tubule dysfunction, defined by two or more of the following : proteinuria, phosphate leak, aminoaciduria, hyperuricuria, and/or glycosuria	During the first 10 days of hospitalization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Capacity of infection of urine viral particles	Study of the capacity for cell infection in vitro by viral particles detected in urine.	During the first 10 days of hospitalization
Sequencing viral particles to identify possible compartmentalization of the virus	Study by sequencing of the compartmentalization of urinary and nasopharyngeal variants of SARS-CoV-2 in patients with positive urine for SARS-CoV-2.	During the first 10 days of hospitalization

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France

Publications and helpful links

General Publications

• Kormann R, Jacquot A, Alla A, Corbel A, Koszutski M, Voirin P, Garcia Parrilla M, Bevilacqua S, Schvoerer E, Gueant JL, Namour F, Levy B, Frimat L, Oussalah A. Coronavirus disease 2019: acute Fanconi syndrome precedes acute kidney injury. Clin Kidney J. 2020 Jun 8;13(3):362-370. doi: 10.1093/ckj/sfaa109. eCollection 2020 Jun.

Study record dates

Study Major Dates

• Study Start (Actual): August 19, 2021
• Primary Completion (Anticipated): July 1, 2022
• Study Completion (Anticipated): July 1, 2022

Study Registration Dates

• First Submitted: June 22, 2021
• First Submitted That Met QC Criteria: June 22, 2021
• First Posted (Actual): June 24, 2021

Study Record Updates

• Last Update Posted (Actual): August 30, 2021
• Last Update Submitted That Met QC Criteria: August 24, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Infections
• Other Study ID Numbers: 2021-A00724-37

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No