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

SARS-CoV2 Infection Clinical Trial

— CovUrinePTD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04937712
• Other study ID #: 2021-A00724-37
• Status: Recruiting
• Start date: August 19, 2021
• Est. completion date: July 1, 2022

Study information

• Verified date: August 2021
• Source: Central Hospital, Nancy, France
• Contact: Raphaël Kormann
• Phone: +33383155533
• Email: r.kormann[@]chru-nancy.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: July 1, 2022
• Est. primary completion date: July 1, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infection
• SARS-CoV2 Infection

Intervention

Other:
• RT-PCR SARS-COV2 in urine
proteinuria/renal phosphate leak/uricosuria/glycosuria/ aminoaciduria)

Locations

Country	Name	City	State
France	Chru Brabois	Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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