Assesment of the Metabolomic Signature in COVID-19 Patients

Not Applicable

Completed

• Conditions: COVID 19
• Interventions: Other: COVID-19 patients

• Registration Number: NCT04497272
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-03
• Study First Submitted QC: 2020-08-03
• Study First Posted: 2020-08-04
• Study Start: 2020-08-07
• Primary Completion: 2021-03-01
• Status Verified: 2022-05
• Study Completion: 2022-07-31
• Last Update Submitted: 2022-08-30
• Last Update Posted: 2022-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
The metabolomic signature of COVID-19 patients	COVID-19 patients	It will consist in the collection of 1 additional tubes at their blood draw and 1 urine sample.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

CHU de nice; 🇫🇷 Nice, Alpes-Maritimes, France