Assesment of the Metabolomic Signature in COVID-19 Patients

COVID 19 Clinical Trial

— SignCov  

Official title:

Assesment of the Metabolomic Signature in COVID-19 Patients (SignCov Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04497272
• Other study ID #: 20-PP-18
• Status: Completed
• Phase: N/A
• Start date: August 7, 2020
• Est. completion date: July 31, 2022

Study information

• Verified date: May 2022
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: July 31, 2022
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID 19
• COVID-19

Intervention

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

Locations

Country	Name	City	State
France	CHU de nice	Nice	Alpes-Maritimes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Enrollment