Rapid Detection of COVID-19 by Portable and Connected Biosensor

Completed

• Conditions: Sars-CoV2

• Registration Number: NCT04367142
• Lead Sponsor: University Hospital, Lille

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-27
• Study First Submitted QC: 2020-04-27
• Study First Posted: 2020-04-29
• Study Start: 2020-08-24
• Status Verified: 2023-05
• Primary Completion: 2023-05-02
• Study Completion: 2023-05-02
• Last Update Submitted: 2024-12-12
• Last Update Posted: 2024-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)

Trial Locations

Locations (1)

CHU lille; 🇫🇷 Lille, France