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

NCT ID: NCT04780334

Last Updated: 2024-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-07

Study Completion Date

2022-05-02

Brief Summary

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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.

Detailed Description

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Conditions

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SARS-CoV Infection Covid19

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Positive diagnosis of SARS-CoV-2

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

COVID-19 RT-PCR

Intervention Type DIAGNOSTIC_TEST

Nasopharyngeal swabs for COVID-19 RT-PCR

Biosensor

Intervention Type DIAGNOSTIC_TEST

Portable and Connected Biosensor viral

Negative diagnosis of SARS-CoV-2

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

COVID-19 RT-PCR

Intervention Type DIAGNOSTIC_TEST

Nasopharyngeal swabs for COVID-19 RT-PCR

Biosensor

Intervention Type DIAGNOSTIC_TEST

Portable and Connected Biosensor viral

Interventions

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COVID-19 RT-PCR

Nasopharyngeal swabs for COVID-19 RT-PCR

Intervention Type DIAGNOSTIC_TEST

Biosensor

Portable and Connected Biosensor viral

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Enagnon Kazali ALIDJINOU, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

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Hopital Roger Salengro, CHU Lille

Lille, , France

Site Status

Countries

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France

Other Identifiers

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2021-A00387-34

Identifier Type: OTHER

Identifier Source: secondary_id

2021_0063

Identifier Type: -

Identifier Source: org_study_id