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Feasibility and Analytic Performance of TestNPass (IVDMD) for CoViD-19 Diagnosis on Saliva Sample (GraphealNpas)

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ClinicalTrials.gov Identifier: NCT04654442
Recruitment Status : Recruiting
First Posted : December 4, 2020
Last Update Posted : May 5, 2021
Sponsor:
Collaborator:
Grapheal
Information provided by (Responsible Party):
University Hospital, Grenoble

Brief Summary:

COVID19 pandemic and SARS-CoV-2 rapid progression worldwide are already historical landmarks of the 21st century owing to the magnitude of the event and the collective response that populations have adopted to face such threat. This menace has imposed an unprecedented reactivity to promptly deliver answers in various fields and specifically in termes of diagnostic capabilities.

The very first tests to be used were based on PCR reactions and on deep nasopharyngeal sampling. But this has shown to be insufficient to prevent contaminations and limit the progression of the disease. This approach requires important infrastructure thus limiting the extent to which it can be delivered. Moreover, nasopharyngeal swab is highly intrusive and therefore is not suitable for repeated testing of asymptomatic patients in surveillance programs.

Actual need is based on new tests offering new capabilities both in terms of wide range availability, ease of use and reduced time-to-result duration. Such tests, affordable and that can be performed outside the lab would ultimately relief pressure on healthcare workers and laboratory facilities as well as help test massively wide range of populations thus limiting viral dissemination

Such innovating test device has been developped by the start-up "Grapheal" and the present study will ultimately demonstrate the feasibility of COVID-19 diagnostic using this test.


Condition or disease Intervention/treatment
Covid19 SARS-CoV-2 Diagnostic Test: TestNPass

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Evaluation of the Feasibility and Analytic Performance of TestNPass (In Vitro Diagnosis Medical Device) for CoViD-19 Diagnosis on Saliva Sample. : a Pilot Study
Actual Study Start Date : March 4, 2021
Estimated Primary Completion Date : May 5, 2021
Estimated Study Completion Date : May 5, 2021

Group/Cohort Intervention/treatment
Cases
30 cases will be recruited : Patient diagnosed by RT-PCR for a COVID19 at Grenoble University Hospital
Diagnostic Test: TestNPass
Patients will undergo saliva sampling. Grenoble University Hospital lab will perform diagnosis using TestNPass IVDMD. Results won't be used for patient care (only recorded for RESEARCH purpose).

Controls
30 controls will be recruited : Patient suspected for a COVID-19 but negative by RT-PCR for a COVID19 at Grenoble University Hospital
Diagnostic Test: TestNPass
Patients will undergo saliva sampling. Grenoble University Hospital lab will perform diagnosis using TestNPass IVDMD. Results won't be used for patient care (only recorded for RESEARCH purpose).




Primary Outcome Measures :
  1. Feasibility of TestNPass IVDMD for CoViD19 diagnosis on saliva samples. [ Time Frame: DAY0 (single visit study, day of COVID19 diagnosis) ]
    Electric signal obtained in TestNPass Graphene Biosensor for samples collected from known COVID19 positive patients.


Secondary Outcome Measures :
  1. TestNPass IVDMD swiftness [ Time Frame: DAY0 (single visit study, day of COVID19 diagnosis) ]
    Number of failure to obtain data form TestNPass IVDMD in 10 minutes.

  2. TestNPass IVDMD ease of use [ Time Frame: DAY0 (single visit study, day of COVID19 diagnosis) ]
    Number of "ease of use" score below 22 (included).

  3. Analytics performance (sensibility) of TestNPass IVDMD [ Time Frame: DAY0 (single visit study, day of COVID19 diagnosis) ]
    TestNPass IVDMD sensibility (in %)

  4. Analytics performance (specificity) of TestNPass IVDMD [ Time Frame: DAY0 (single visit study, day of COVID19 diagnosis) ]
    TestNPass IVDMD specificity (in %)

  5. Correlation of TestNPass electric signal intensity with RT-PCR Cycle threshold [ Time Frame: DAY0 (single visit study, day of COVID19 diagnosis) ]
    TestNPass electric signal amplitude (in %) versus RT-PCR Ct (in AU)


Biospecimen Retention:   Samples Without DNA
Saliva Nasopharyngeal swab


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient suspected of a COVID19
Criteria

Inclusion Criteria:

  • Men or Women over 18 years old
  • suspect of COVID19 and consulting for a diagnosis at Grenoble University Hospital.
  • Duly informed and not opposed to participation at GraphealNPass' study
  • Affiliated to french social security.

Exclusion Criteria:

Patients protected by law (minors, pregnant or breastfeeding woman, patient under guardianship or deprived of his/her liberty or hospitalized without his/her consent)


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): NCT04654442


Contacts
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Contact: Benjamin Némoz, Némoz +33 4 76 76 63 16 BNemoz1@chu-grenoble.fr
Contact: Pierre AUDOIN, MS +334 76 76 95 98 paudoin@chu-grenoble.fr

Locations
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France
Grenoble University Hospital Recruiting
Grenoble cedex 9, France, 38043
Contact: Benjamin Némoz, MD    +334 76 76 63 16    BNemoz1@chu-grenoble.fr   
Sub-Investigator: Marion Le Maréchal, MD         
Sponsors and Collaborators
University Hospital, Grenoble
Grapheal
Investigators
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Principal Investigator: Benjamin Némoz, MD University Hospital, Grenoble
Additional Information:
Publications:

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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT04654442    
Other Study ID Numbers: 38RC20.378
2020-A03087-32 ( Other Identifier: ID RCB )
First Posted: December 4, 2020    Key Record Dates
Last Update Posted: May 5, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Grapheal and Grenoble University Hospital will decide to share IPD if possible according to GPDR regulation.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Grenoble:
saliva
IVDMD (in vitro diagnosis medical device)