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

Sponsor

University Hospital, Grenoble (Other)

Overall Status

Recruiting

CT.gov ID

NCT04597216

Collaborator

(none)

200

Enrollment

Location

Arm

14.5

Anticipated Duration (Months)

13.8

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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

Study Type:

Interventional

Anticipated 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-19phase 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

Anticipated Study Start Date :

Oct 15, 2020

Anticipated Primary Completion Date :

Dec 31, 2020

Anticipated Study Completion Date :

Dec 31, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	olivier EPAULARD	Grenoble		France	38043

Sponsors and Collaborators

University Hospital, Grenoble

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Grenoble

ClinicalTrials.gov Identifier:

NCT04597216

Other Study ID Numbers:

38RC20.289

First Posted:

Oct 22, 2020

Last Update Posted:

Oct 22, 2020

Last Verified:

Oct 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Oct 22, 2020