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SignCov: Assesment of the Metabolomic Signature in COVID-19 Patients

Sponsor
Centre Hospitalier Universitaire de Nice (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04497272
Collaborator
(none)
150
Enrollment
1
Location
1
Arm
23.8
Anticipated Duration (Months)
6.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: COVID-19 patients
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Patient with COVID-19 diseasePatient with COVID-19 disease
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Assesment of the Metabolomic Signature in COVID-19 Patients (SignCov Study)
Actual Study Start Date :
Aug 7, 2020
Actual Primary Completion Date :
Mar 1, 2021
Anticipated Study Completion Date :
Jul 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Other: The metabolomic signature of COVID-19 patients

It will consist in the collection of 1 additional tubes at their blood draw and 1 urine sample.

Other: COVID-19 patients
It will consist in the collection of 1 additional tubes at their blood draw and 1 urine sample.

Outcome Measures

Primary Outcome Measures

  1. Identifying the metabolomic signature [Enrollment]

    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

  1. Identification of the metabolomic profile according to clinical severity. [Enrollment]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU de nice Nice Alpes-Maritimes France 06001

Sponsors and Collaborators

  • Centre Hospitalier Universitaire de Nice

Investigators

  • Principal Investigator: OCCELLI Céline, Néphrologie, CHU de Nice

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT04497272
Other Study ID Numbers:
  • 20-PP-18
First Posted:
Aug 4, 2020
Last Update Posted:
Jun 1, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
COVID-19

Study Results

No Results Posted as of Jun 1, 2022