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

NCT ID: NCT04597216

Last Updated: 2020-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-15

Study Completion Date

2021-12-31

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.

Conditions

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Covid19

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

phase 1: patients with Covid-19 or with anotther respiratory infection phase 2 : patients with a supsected Covid-19
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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unique arm

there is only 1 arm in this study (all the participants will undergo the same diagnosis procedure)

Group Type OTHER

sample of blood and saliva

Intervention Type DEVICE

sample of 3ml of blood by veinous puncture, of 1 drop of blood by needlestick, and of saliva by spitting

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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


* negative Covid-19 PCR
* acute respiratory infection


* suspicion of Covid-19
* sample for Covid-19 PCR planned or performed the same day

Exclusion Criteria

* asymptomatic Covid-19 infection


* none

Phase 2

* past known Covid-19
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Grenoble

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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olivier EPAULARD

Grenoble, , France

Site Status RECRUITING

Countries

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France

Facility Contacts

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olivier EPAULARD

Role: primary

0033476765291

Other Identifiers

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38RC20.289

Identifier Type: -

Identifier Source: org_study_id

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