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

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ClinicalTrials.gov Identifier: NCT04780334
Recruitment Status : Not yet recruiting
First Posted : March 3, 2021
Last Update Posted : March 3, 2021
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

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
SARS-CoV Infection Covid19 Diagnostic Test: COVID-19 RT-PCR Diagnostic Test: Biosensor

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Study Type : Observational
Estimated 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
Estimated Study Start Date : April 2021
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine


Group/Cohort 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




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 [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: at patient admission (Baseline) ]

Biospecimen Retention:   None Retained
nasopharyngeal swab and saliva


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients admitted to a Reference Health Establishment for suspicion of SARS-CoV-2
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04780334


Contacts
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Contact: Enagnon Kazali ALIDJINOU, MD 0320445962 ext +33 EnagnonKazali.ALIDJINOU@CHRU-LILLE.FR
Contact: David Devos, MD,PhD david.devos@chru-lille.fr

Sponsors and Collaborators
University Hospital, Lille
Investigators
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Principal Investigator: Enagnon Kazali ALIDJINOU, MD University Hospital, Lille
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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT04780334    
Other Study ID Numbers: 2021_0063
2021-A00387-34 ( Other Identifier: ID-RCB number, ANSM )
First Posted: March 3, 2021    Key Record Dates
Last Update Posted: March 3, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Severe Acute Respiratory Syndrome
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases