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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Exploration of Feasability of Blood and Saliva Proteomic Analysis Through Harvesting by Silica Matrix

Conditions
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Covid19

Intervention / Treatment
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* Device: sample of blood and saliva


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: unique arm<br>there is only 1 arm in this study (all the participants will undergo the same diagnosis procedure) | Device: sample of blood and saliva<br>* sample of 3ml of blood by veinous puncture, of 1 drop of blood by needlestick, and of saliva by spitting<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of proteomic profile | MALDI-TOF mass spectrometric analysis of blood and saliva proteins to obtain a specific proteomic profile (obtained or not) | one day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interest of proteomic profile | Correlation between spectral analysis and severity of pathology at admission. | one day | 
| Stability of proteomic profile | Evaluation of mass spectrometric analysis reproductibility 48 hours after ambiant temperature conservation | two days |