Rapid Detection of COVID-19 by Portable and Connected Biosensor

Sars-CoV2 Clinical Trial

— COR-DIAL-1  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04367142
• Other study ID #: 2020_36
• Secondary ID: 2020-A01147-32
• Status: Recruiting
• Start date: August 24, 2020
• Est. completion date: December 2022

Study information

• Verified date: April 2022
• Source: University Hospital, Lille
• Contact: Enagnon Kazali ALIDJINOU, MD
• Phone: (0)3.20.44.45.97
• Email: EnagnonKazali.ALIDJINOU[@]CHRU-LILLE.FR
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Sars-CoV2

Intervention

Diagnostic Test:
• COVID-19 RT-PCR
Nasopharyngeal swabs for COVID-19 RT-PCR
• Biosensor
Portable and Connected Biosensor viral

Locations

Country	Name	City	State
France	CHU lille	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)