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

NCT04780334 | Completed

• 2 other identifiers: 2021_00632021-A00387-34
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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. 1.greater sensitivity
2. 2.a great speed because 8tests could be performed at the same time with a result in a few minutes
3. 3.a very high specificity at least equivalent to PCR.

Conditions

SARS-CoV Infection; Covid19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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)

• 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)

• 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)

Study Arms (2)

Positive diagnosis of SARS-CoV-2

100 patients with a positive diagnosis of SARS-CoV-2

Diagnostic Test: COVID-19 RT-PCR; Diagnostic Test: Biosensor

Negative diagnosis of SARS-CoV-2

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; Diagnostic Test: Biosensor

Interventions

COVID-19 RT-PCR DIAGNOSTIC_TEST

Nasopharyngeal swabs for COVID-19 RT-PCR

Negative diagnosis of SARS-CoV-2; Positive diagnosis of SARS-CoV-2

Biosensor DIAGNOSTIC_TEST

Portable and Connected Biosensor viral

Negative diagnosis of SARS-CoV-2; Positive diagnosis of SARS-CoV-2

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

Hopital Roger Salengro, CHU Lille

Lille, 59037, France

Location

Biospecimen

Retention: NONE RETAINED

nasopharyngeal swab and saliva

MeSH Terms

Conditions

Severe Acute Respiratory Syndrome; COVID-19

Interventions

COVID-19 Nucleic Acid Testing

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases

Intervention Hierarchy (Ancestors)

COVID-19 Testing; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Enagnon Kazali ALIDJINOU, MD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2021
• First Posted: March 3, 2021
• Study Start: July 7, 2021
• Primary Completion: May 2, 2022
• Study Completion: May 2, 2022
• Last Updated: December 13, 2024

Record last verified: 2023-05

Locations

FR (1)