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CompletedNCT04367142COR-DIAL-1Updated Dec 17, 2024

Rapid Detection of COVID-19 by Portable and Connected Biosensor

An observational study in Sars-CoV2, sponsored by University Hospital, Lille. Completed at 1 site in France. Per ClinicalTrials.gov, last updated 2024-12-17.

Sponsored by University Hospital, Lille · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
200
Sex
All
01

Study summary

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.

02

Conditions studied

  • Sars-CoV2
03

In context

Lead sponsor

University Hospital, Lille is the lead sponsor of 625 studies on the registry; 141 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

patients admitted to a Reference Health Establishment for suspicion of SARS-CoV-2

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

Exclusion Criteria:

  • Atypical or suspicious cases without a final diagnosis of COVID-19 positive or negative
  • Patient refusal to participate
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
200 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • positive SARS-Cov2

    100 patients with a positive diagnosis of SARS-CoV-2

    Diagnostic Test: COVID-19 RT-PCR · Diagnostic Test: Biosensor

  • negative SARS-Cov2

    100 patients with a negative diagnosis of SARS-CoV-2 defined by the gold standard by the medical team

    Diagnostic Test: COVID-19 RT-PCR · Diagnostic Test: Biosensor

Interventions

  • Diagnostic testCOVID-19 RT-PCR

    Nasopharyngeal swabs for COVID-19 RT-PCR

  • Diagnostic testBiosensor

    Portable and Connected Biosensor viral

06

What researchers measure

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)

07

Study locations

1 site
  • CHU lille
    Lille, 59037, France
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 17, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04367142
Lead sponsor
University Hospital, Lille
Responsible party
Sponsor
First posted
Apr 29, 2020
Start date
Aug 24, 2020
Primary completion
May 2, 2023
Completion
May 2, 2023
Last update
Dec 17, 2024

Study contacts

Enagnon Kazali ALIDJINOU, MD
principal investigator · University Hospital, Lille

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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