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

Covid19 Clinical Trial

— COR-DIAL-S  

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: NCT04780334
• Other study ID #: 2021_0063
• Secondary ID: 2021-A00387-34
• Status: Recruiting
• Start date: July 7, 2021
• Est. completion date: July 2023

Study information

• Verified date: March 2022
• Source: University Hospital, Lille
• Contact: Enagnon Kazali ALIDJINOU, MD
• Phone: 0320445962
• Email: EnagnonKazali.ALIDJINOU[@]CHRU-LILLE.FR
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 2023
• Est. primary completion date: July 2023
• 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 (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

Related Conditions & MeSH terms

• COVID-19
• Covid19
• SARS-CoV Infection
• Severe Acute Respiratory Syndrome

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	Hopital Roger Salengro, 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 CorDial-S based on the first nasopharyngeal swab taken on patient admission, compared to the final positive or negative diagnosis of COVID-19 by the medical team		at patient admission (Baseline)
Secondary	Cohen's Kappa Coefficient for concordance for the diagnosis of CoV-2-SARS between PCR and CorDial-S based on nasopharyngeal swabs taken at patient admission.		at patient admission (Baseline)
Secondary	Sensitivity and specificity of CorDial-S based on the first saliva sample taken at patient admission compared to the final positive or negative diagnosis of COVID-19 by the medical team.		at patient admission (Baseline)
Secondary	Cohen's Kappa Coefficient for concordance for the diagnosis of CoV-2-SARS between PCR and CorDial-S based on saliva samples taken at patient admission.		at patient admission (Baseline)