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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
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for COVID 19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
August 3, 2020
Last Updated
August 30, 2022
Sponsor
Centre Hospitalier Universitaire de Nice
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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

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