Assesment of the Metabolomic Signature in COVID-19 Patients

NCT04497272 | Completed

• 1 other identifier: 20-PP-18
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID 19

Outcome Measures

Primary Outcomes (1)

• 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

  Enrollment

Secondary Outcomes (1)

• Identification of the metabolomic profile according to clinical severity.

  Enrollment

Study Arms (1)

The metabolomic signature of COVID-19 patients

OTHER

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

Other: COVID-19 patients

Interventions

COVID-19 patients OTHER

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

The metabolomic signature of COVID-19 patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de nice

Nice, Alpes-Maritimes, 06001, France

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• OCCELLI Céline

  Néphrologie, CHU de Nice

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patient with COVID-19 disease

Study Record Dates

• First Submitted: August 3, 2020
• First Posted: August 4, 2020
• Study Start: August 7, 2020
• Primary Completion: March 1, 2021
• Study Completion: July 31, 2022
• Last Updated: August 31, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)