Clinical trial NCT04597216: Exploration of Feasability of Blood and Saliva Proteomic Analysis Through Harvesting by Silica Matrix (NanoDx-CoV-19)
Official title: Exploration of Feasability of Blood and Saliva Proteomic Analysis Through Harvesting by Silica Matrix
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Covid19
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2020-10-22
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: phase 1: patients with Covid-19 or with anotther respiratory infection phase 2 : patients with a supsected Covid-19
Primary purpose: DIAGNOSTIC

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.

Eligibility 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

Primary outcomes:
measure: Feasibility of proteomic profile
timeFrame: one day
Secondary outcomes:
measure: Interest of proteomic profile
timeFrame: one day
measure: Stability of proteomic profile
timeFrame: two days
Other outcomes:
Locations:
city: Grenoble
country: France
facility: olivier EPAULARD
Study officials:
References: