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Completed

NCT Number: NCT04780334

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

The main objective of this CorDial-S proof-of-concept study is to evaluate the ability to detect COVID-19 infection in nasopharyngeal swabs with CorDial-S and compare it to the PCR technique currently in use. Saliva analysis will be the subject of secondary analysis.

The CorDial-S medical device could allow the specimens to be analyzed using a small portable device and the results to be returned in minutes to the medical team and the patient, and communicated in real time with a telemedicine and remote monitoring system to the health authorities to allow the necessary protective, containment and therapeutic management measures to be put in place if necessary.

The benefits would be

1. greater sensitivity 2. a great speed because 8tests could be performed at the same time with a result in a few minutes 3. a very high specificity at least equivalent to PCR.

This new diagnostic strategy could become extremely valuable in the fight against COVID-19, especially in the case of very long-term persistence and incomplete vaccination of the French and foreign population.

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Key information

Conditions

SARS-CoV Infection COVID-19 Coronaviridae Infections Coronavirus Infections Covid19 Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Severe Acute Respiratory Syndrome Virus Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Hopital Roger Salengro, 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 (RHS) in an emergency unit, hospitalization or intensive care unit for suspicion of SARS-CoV-2 infection regardless of clinical presentation and degree of severity.
  • Patient to be diagnosed by PCR test on nasopharyngeal swab.
  • Social insured

Exclusion criteria

  • Refusal of the person to participate (collection of information, second use of his sample, collection of saliva by spitting)
  • Pregnant and breastfeeding women
  • Protected Majors

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 CorDial-S based on the first nasopharyngeal swab taken on patient admission, compared to the final positive or negative diagnosis of COVID-19 by the medical team

    Time frame: at patient admission (Baseline)

Secondary outcomes

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

    Time frame: at patient admission (Baseline)

  2. Sensitivity and specificity of CorDial-S based on the first saliva sample taken at patient admission compared to the final positive or negative diagnosis of COVID-19 by the medical team.

    Time frame: at patient admission (Baseline)

  3. Cohen's Kappa Coefficient for concordance for the diagnosis of CoV-2-SARS between PCR and CorDial-S based on saliva samples taken at patient admission.

    Time frame: at patient admission (Baseline)

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Acronym: COR-DIAL-S

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 3, 2021
Registry last updated
Dec 13, 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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