Rapid Detection of COVID-19 by Portable and Connected Biosensor (COR-DIAL-1)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Sars-CoV2
• Intervention / Treatment: Diagnostic test: COVID-19 RT-PCR; Diagnostic test: Biosensor

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Enagnon Kazali ALIDJINOU, MD; Phone Number: +33 (0)3.20.44.45.97; Email: EnagnonKazali.ALIDJINOU@CHRU-LILLE.FR
• Study Contact Backup: Name: David Devos, MD,PhD

Study Locations

• France
  • Lille, France, 59037
    • Recruiting
    • CHU Lille
    • Principal Investigator: Enagnon-Kazali ALIDJINOU, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
positive SARS-Cov2; 100 patients with a positive diagnosis of SARS-CoV-2	Diagnostic test: COVID-19 RT-PCR; Nasopharyngeal swabs for COVID-19 RT-PCR; Diagnostic test: Biosensor; 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	Diagnostic test: COVID-19 RT-PCR; Nasopharyngeal swabs for COVID-19 RT-PCR; Diagnostic test: Biosensor; Portable and Connected Biosensor viral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	Baseline (at admission)

Secondary Outcome Measures

Outcome Measure	Time Frame
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	Baseline (at admission)

Collaborators and Investigators

• Sponsor: University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): August 24, 2020
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: April 27, 2020
• First Submitted That Met QC Criteria: April 27, 2020
• First Posted (Actual): April 29, 2020

Study Record Updates

• Last Update Posted (Actual): April 29, 2022
• Last Update Submitted That Met QC Criteria: April 28, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 2020_36; 2020-A01147-32 (Other Identifier: ID-RCB number,ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No