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

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

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.

Study Overview

• Status: Unknown
• Conditions: Covid19
• Intervention / Treatment: Device: sample of blood and saliva

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 Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Grenoble, France, 38043
    • Recruiting
    • Olivier EPAULARD
    • Contact: olivier EPAULARD; Phone Number: 0033476765291; Email: oepaulard@chu-grenoble.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble

Study record dates

Study Major Dates

• Study Start (Anticipated): October 15, 2020
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: October 13, 2020
• First Submitted That Met QC Criteria: October 20, 2020
• First Posted (Actual): October 22, 2020

Study Record Updates

• Last Update Posted (Actual): October 22, 2020
• Last Update Submitted That Met QC Criteria: October 20, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 38RC20.289

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No