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Exploration of Feasability of Blood and Saliva Proteomic Analysis Through Harvesting by Silica Matrix (NanoDx-CoV-19) (NanoDxCoV19)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04597216
Recruitment Status : Recruiting
First Posted : October 22, 2020
Last Update Posted : October 22, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

Study Description
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Brief Summary:

Phase 1:

25 patients with a PCR-based diagnosis of Covid-19 will be be included to give 500 microliters of saliva and a 3 ml sample of blood for proteomic analysis; a drop of blood will also be put in a device connected to a silica matrix to perform spectrometric analyses. 25 patients with a non-Covid-19 respiratory infection will be included for the same samples. The proteomic analyses will be performed from classicaly draught blood, blood drop on silica, and saliva, to search for discriminating profiles between Covid-19 and non-Covid-19.

Phase 2:

150 patients with a suspected Covid-19 will be included at the same time than the Covid-19PCR is performed ; they will have a sample of saliva and of a drop of blood for proteomic analysis, whose results will be matched with PCR results.


Condition or disease Intervention/treatment Phase
Covid19 Device: sample of blood and saliva Not Applicable

Detailed Description:

Phase 1: derivation analyses 25 patients with a PCR-based diagnosis of Covid-19 will be be included to give 500 microliters of saliva and a 3 ml sample of blood for proteomic analysis; a drop of blood will also be put in a device connected to a silica matrix to perform spectrometric analyses. 25 patients with a non-Covid-19 respiratory infection will be included for the same samples. The proteomic analyses will be performed from classicaly draught blood, blood drop on silica, and saliva, to search for discriminating profiles between Covid-19 and non-Covid-19.

Phase 2: confirmation analyses 150 patients with a suspected Covid-19 will be included at the same time than the Covid-19PCR is performed ; they will have a sample of saliva and of a drop of blood for proteomic analysis, whose results will be matched with PCR results.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: phase 1: patients with Covid-19 or with anotther respiratory infection phase 2 : patients with a supsected Covid-19
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Exploration of Feasability of Blood and Saliva Proteomic Analysis Through Harvesting by Silica Matrix
Estimated Study Start Date : October 15, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2021
Arms and Interventions
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Arm Intervention/treatment
unique arm
there is only 1 arm in this study (all the participants will undergo the same diagnosis procedure)
 Device: sample of blood and saliva
sample of 3ml of blood by veinous puncture, of 1 drop of blood by needlestick, and of saliva by spitting


Outcome Measures
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Primary Outcome Measures :
  1. Feasibility of proteomic profile [ Time Frame: one day ]
    MALDI-TOF mass spectrometric analysis of blood and saliva proteins to obtain a specific proteomic profile (obtained or not)


Secondary Outcome Measures :
  1. Interest of proteomic profile [ Time Frame: one day ]
    Correlation between spectral analysis and severity of pathology at admission.

  2. Stability of proteomic profile [ Time Frame: two days ]
    Evaluation of mass spectrometric analysis reproductibility 48 hours after ambiant temperature conservation


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

phase 1:

Inclusion Criteria for group 1:

  • positive Covid-19 PCR
  • clinical signs evocative of Covid-19

Exclusion Criteria for group 1:

  • asymptomatic Covid-19 infection

Inclusion Criteria for group 1:

  • negative Covid-19 PCR
  • acute respiratory infection

Exclusion Criteria for group 1:

  • none

Phase 2

Inclusion Criteria:

  • suspicion of Covid-19
  • sample for Covid-19 PCR planned or performed the same day
  • admission ot emergency room exclusion criteria:
  • past known Covid-19
Contacts and Locations
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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): NCT04597216


Locations
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France
olivier EPAULARD Recruiting
Grenoble, France, 38043
Contact: olivier EPAULARD    0033476765291    oepaulard@chu-grenoble.fr   
Sponsors and Collaborators
University Hospital, Grenoble
More Information
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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT04597216    
Other Study ID Numbers: 38RC20.289
First Posted: October 22, 2020    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No