Rapid Detection of COVID-19 by Portable and Connected Biosensor

NCT ID: NCT04367142

Last Updated: 2024-12-17

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

2020-08-24

Study Completion Date

2023-05-02

Brief Summary

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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.

Detailed Description

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Conditions

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Sars-CoV2

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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positive SARS-Cov2

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 SARS-Cov2

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 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
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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CHU lille

Lille, , France

Site Status

Countries

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France

Other Identifiers

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2020-A01147-32

Identifier Type: OTHER

Identifier Source: secondary_id

2020_36

Identifier Type: -

Identifier Source: org_study_id