Assesment of the Metabolomic Signature in COVID-19 Patients (SignCov)
Primary Purpose
COVID 19
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
COVID-19 patients
Sponsored by
About this trial
This is an interventional diagnostic trial for COVID 19
Eligibility Criteria
Inclusion Criteria:
- patient over 18 years of age
- affiliated to a social security scheme
- consultant in the emergency department and/or being hospitalized for suspected SARS CoV infection
- confirmation, after medical examination, of the need for a biological examination (this will negate the need for additional venipuncture)
Exclusion criteria:
- Patient who do not meet inclusion criteria
- Person subject to a guardianship order
- Opposition to the use of the data or samples (withdrawal of non-opposition) / Sponsor's or investigator's decision
Sites / Locations
- CHU de nice
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
The metabolomic signature of COVID-19 patients
Arm Description
It will consist in the collection of 1 additional tubes at their blood draw and 1 urine sample.
Outcomes
Primary Outcome Measures
Identifying the metabolomic signature
To dentified a metabolomic profile using liquid chromatography combined with mass spectrometry (LC-MS) on the serum and urine of COVID-19 patients
Secondary Outcome Measures
Identification of the metabolomic profile according to clinical severity.
Identification of the metabolomic profile of patients infected with SARS CoV 2 in the following subgroups: pauci-symptomatic patients, symptomatic patients without clinical severity criteria, and critically ill COVID-19 patients.
Full Information
NCT ID
NCT04497272
First Posted
August 3, 2020
Last Updated
August 30, 2022
Sponsor
Centre Hospitalier Universitaire de Nice
1. Study Identification
Unique Protocol Identification Number
NCT04497272
Brief Title
Assesment of the Metabolomic Signature in COVID-19 Patients
Acronym
SignCov
Official Title
Assesment of the Metabolomic Signature in COVID-19 Patients (SignCov Study)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
August 7, 2020 (Actual)
Primary Completion Date
March 1, 2021 (Actual)
Study Completion Date
July 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Metabolomics is the analysis of small molecules in a biological sample (cells, tissues or biological fluids). It can potentially detect very sensitively any change related to a pathology or exposure to a toxic agent. The analyses are fast, inexpensive and therefore applicable in routine, particularly in health care. Given the emergence of this new disease, COVID-19, there is a real need to better understand the pathophysiological mechanisms of SARS-CoV-2 infection. In this context, metabolomics could have a place and could lead to the development of interesting diagnostic or prognostic tools. The objective of this study is to identify, through the analysis of biological samples (blood and urine), whether there is a metabolomic signature in patients with COVID-19.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID 19
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Patient with COVID-19 disease
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
The metabolomic signature of COVID-19 patients
Arm Type
Other
Arm Description
It will consist in the collection of 1 additional tubes at their blood draw and 1 urine sample.
Intervention Type
Other
Intervention Name(s)
COVID-19 patients
Intervention Description
It will consist in the collection of 1 additional tubes at their blood draw and 1 urine sample.
Primary Outcome Measure Information:
Title
Identifying the metabolomic signature
Description
To dentified a metabolomic profile using liquid chromatography combined with mass spectrometry (LC-MS) on the serum and urine of COVID-19 patients
Time Frame
Enrollment
Secondary Outcome Measure Information:
Title
Identification of the metabolomic profile according to clinical severity.
Description
Identification of the metabolomic profile of patients infected with SARS CoV 2 in the following subgroups: pauci-symptomatic patients, symptomatic patients without clinical severity criteria, and critically ill COVID-19 patients.
Time Frame
Enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patient over 18 years of age
affiliated to a social security scheme
consultant in the emergency department and/or being hospitalized for suspected SARS CoV infection
confirmation, after medical examination, of the need for a biological examination (this will negate the need for additional venipuncture)
Exclusion criteria:
Patient who do not meet inclusion criteria
Person subject to a guardianship order
Opposition to the use of the data or samples (withdrawal of non-opposition) / Sponsor's or investigator's decision
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
OCCELLI Céline
Organizational Affiliation
Néphrologie, CHU de Nice
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de nice
City
Nice
State/Province
Alpes-Maritimes
ZIP/Postal Code
06001
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Assesment of the Metabolomic Signature in COVID-19 Patients
We'll reach out to this number within 24 hrs