Clinical trial NCT04780334: Rapid Detection of COVID-19 by Portable and Connected Biosensor : Biological Proof of Concept
Official title: Rapid Detection of COVID-19 by Portable and Connected Biosensor : Biological Proof of Concept
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SARS-CoV Infection
Covid19
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2021-03-03
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients admitted to a Reference Health Establishment for suspicion of SARS-CoV-2

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: at patient admission (Baseline)
Secondary outcomes:
measure: 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.
timeFrame: at patient admission (Baseline)
measure: 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.
timeFrame: at patient admission (Baseline)
measure: 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.
timeFrame: at patient admission (Baseline)
Other outcomes:
Locations:
city: Lille
country: France
facility: Hopital Roger Salengro, CHU Lille
Study officials:
affiliation: University Hospital, Lille
name: Enagnon Kazali ALIDJINOU, MD
role: PRINCIPAL_INVESTIGATOR
References: