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

Not Applicable

• Conditions: Covid19
• Interventions: Device: sample of blood and saliva

• Registration Number: NCT04597216
• Lead Sponsor: University Hospital, Grenoble

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.

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 Timeline

• Status Verified: 2020-10
• Study First Submitted: 2020-10-13
• Study Start: 2020-10-15
• Study First Submitted QC: 2020-10-20
• Last Update Submitted: 2020-10-20
• Study First Posted: 2020-10-22
• Last Update Posted: 2020-10-22
• Primary Completion: 2020-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
unique arm	sample of blood and saliva	there is only 1 arm in this study (all the participants will undergo the same diagnosis procedure)

Primary Outcome Measures

Name	Time	Method
Feasibility of proteomic profile	one day	MALDI-TOF mass spectrometric analysis of blood and saliva proteins to obtain a specific proteomic profile (obtained or not)

Secondary Outcome Measures

Name	Time	Method
Stability of proteomic profile	two days	Evaluation of mass spectrometric analysis reproductibility 48 hours after ambiant temperature conservation
Interest of proteomic profile	one day	Correlation between spectral analysis and severity of pathology at admission.

Trial Locations

Locations (1)

olivier EPAULARD; 🇫🇷 Grenoble, France