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

• Conditions: Proximal Tubule Dysfunction; SARS-CoV2 Infection

• Registration Number: NCT04937712
• Lead Sponsor: Central Hospital, Nancy, France

Brief Summary

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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-22
• Study First Submitted QC: 2021-06-22
• Study First Posted: 2021-06-24
• Status Verified: 2021-08
• Study Start: 2021-08-19
• Last Update Submitted: 2021-08-24
• Last Update Posted: 2021-08-30
• Primary Completion: 2022-07-01
• Study Completion: 2022-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 34

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
SARS-CoV 2 viruria and its correlation with proximal tubule dysfunction	During the first 10 days of hospitalization	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Chru Brabois; 🇫🇷 Nancy, France