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

Sponsor
University Hospital, Lille (Other)
Overall Status
Recruiting
CT.gov ID
NCT04780334
Collaborator
(none)
200
1
23.8
8.4

Study Details

Study Description

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. 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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: COVID-19 RT-PCR
  • Diagnostic Test: Biosensor

Study Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Rapid Detection of COVID-19 by Portable and Connected Biosensor : Biological Proof of Concept
Actual Study Start Date :
Jul 7, 2021
Anticipated Primary Completion Date :
Jul 1, 2023
Anticipated Study Completion Date :
Jul 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Positive diagnosis of SARS-CoV-2

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 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
Nasopharyngeal swabs for COVID-19 RT-PCR

Diagnostic Test: Biosensor
Portable and Connected Biosensor viral

Outcome Measures

Primary Outcome Measures

  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 Outcome Measures

  1. 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)]

  2. 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)]

  3. 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)]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hopital Roger Salengro, CHU Lille Lille France 59037

Sponsors and Collaborators

  • University Hospital, Lille

Investigators

  • Principal Investigator: Enagnon Kazali ALIDJINOU, MD, University Hospital, Lille

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Lille
ClinicalTrials.gov Identifier:
NCT04780334
Other Study ID Numbers:
  • 2021_0063
  • 2021-A00387-34
First Posted:
Mar 3, 2021
Last Update Posted:
Apr 12, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 12, 2022