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Completed

NCT Number: NCT04497272

Assesment of the Metabolomic Signature in COVID-19 Patients

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.

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Key information

Conditions

COVID 19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de nice

Nice, Alpes-Maritimes, 06001, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

COVID-19 patients

Other

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

Primary outcomes

  1. Identifying the metabolomic signature

    Time frame: 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 outcomes

  1. Identification of the metabolomic profile according to clinical severity.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

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

Acronym: SignCov

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Aug 4, 2020
Registry last updated
Aug 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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