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

Grenoble Alpes University Hospital Center (CHU)

Status: Unknown

Conditions: Covid19

Treatments: Device: sample of blood and saliva

Study type: Interventional

Funder types: Other

Identifiers

NCT04597216

38RC20.289

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

unique arm

Other group

Description:

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

Treatment:

Device: sample of blood and saliva