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OpenTrials
Completed

NCT Number: NCT04367142

Rapid Detection of COVID-19 by Portable and Connected Biosensor

The objective of study is to estimate the sensitivity and specificity of the COR-DIAL based on nasopharyngeal samples taken at the patient's admission in relation to the final diagnosis of COVID-19 made by the medical team.

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Key information

Conditions

Sars-CoV2

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU lille

Lille, 59037, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female or child without age limit
  • Admitted to a Reference Health Establishment in an emergency unit, hospitalisation or intensive care unit for suspicion of SARS-CoV-2 infection, regardless of the clinical presentation and degree of severity.
  • Patient to be diagnosed using a PCR test on nasopharyngeal swab.
  • Social insured

Exclusion criteria

  • Atypical or suspicious cases without a final diagnosis of COVID-19 positive or negative
  • Patient refusal to participate

Treatment and study plan

COVID-19 RT-PCR

Diagnostic Test

Nasopharyngeal swabs for COVID-19 RT-PCR

Biosensor

Diagnostic Test

Portable and Connected Biosensor viral

Primary outcomes

  1. Sensitivity and specificity of the COR-DIAL based on nasopharyngeal swabs taken on admission of the patient compared to the final diagnosis of COVID-19 made by the medical team

    Time frame: Baseline (at admission)

Secondary outcomes

  1. Cohen's Kappa Coefficient for concordance for the diagnosis of CoV-2-SARS between PCR and COR-DIAL based on nasopharyngeal swabs taken on patient admission

    Time frame: Baseline (at admission)

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

Rapid Detection of COVID-19 by Portable and Connected Biosensor : Biological Proof of Concept

Acronym: COR-DIAL-1

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Apr 29, 2020
Registry last updated
Dec 17, 2024

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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