SARS-CoV2 InfectionCovUrinePTDNCT04937712
Analysis of SARS-CoV2 Urine Viral Particles and Association With Proximal Tubular Dysfunction
An observational study of SARS-CoV2 Infection and Proximal Tubule Dysfunction, run by Central Hospital, Nancy, France at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SARS-CoV2 Infection, Proximal Tubule Dysfunction
- What is being tested?
- RT-PCR SARS-COV2 in urine
- How many people
- 34 participants
- Where
- 1 siteFrance
- Study dates
- 19 Aug 2021to 1 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients hospitalized in CHRU Nancy with severe SARS-CoV2 infection, with lung involvement.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Chru Brabois
Nancy, 54000
Raphaël Kormann, MD PhD, 0033383155533, r.kormann@chru-nancy.fr
About this study
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
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)
- Conditions
- SARS-CoV2 Infection, Proximal Tubule Dysfunction
- Being tested
- RT-PCR SARS-COV2 in urine
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RT-PCR SARS-COV2 in urineOther
Also called Proximal tubular dysfunction testing
proteinuria/renal phosphate leak/uricosuria/glycosuria/ aminoaciduria)
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: During the first 10 days of hospitalization
Secondary outcomes (2)
Capacity of infection of urine viral particles
Study of the capacity for cell infection in vitro by viral particles detected in urine.
Measured: 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.
Measured: During the first 10 days of hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2021
- Study start19 Aug 2021
- Primary completion1 Jul 2022 (estimated)
- Study completion1 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SARS-CoV2 InfectionStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raphaël KORMANN, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04937712
- Sponsor's protocol ID
- 2021-A00724-37
- Acronym
- CovUrinePTD
- Status last verified
- Aug 2021
- First submitted
- 22 Jun 2021
- Last updated
- 30 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 32695327
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04937712
- Acronym / sponsor ID
- CovUrinePTD / 2021-A00724-37
- Conditions
- SARS-CoV2 Infection, Proximal Tubule Dysfunction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 19 Aug 2021 (actual)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 24 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalized in CHRU Nancy with severe SARS-CoV2 infection, with lung involvement.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RT-PCR SARS-COV2 in urineAlso: Proximal tubular dysfunction testingproteinuria/renal phosphate leak/uricosuria/glycosuria/ aminoaciduria) | Other | – |
Primary outcome
SARS-CoV 2 viruria and its correlation with proximal tubule dysfunction
Time frame: 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
2 secondary outcomes
Capacity of infection of urine viral particles
Time frame: During the first 10 days of hospitalization
Sequencing viral particles to identify possible compartmentalization of the virus
Time frame: During the first 10 days of hospitalization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2021.
- Background: PubMed 32695327Kormann 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS-CoV2 Infection and Proximal Tubule Dysfunction, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Raphaël Kormann (+33383155533, r.kormann@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SARS-CoV 2 viruria and its correlation with proximal tubule dysfunction (time frame: During the first 10 days of hospitalization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04937712, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2021.