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

Last updated: October 20, 2020
Sponsor: University Hospital, Grenoble
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT04597216
38RC20.289
  • Ages 18-99
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion

  • admission ot emergency room exclusion criteria:

  • past known Covid-19

Study Design

Total Participants: 200
Study Start date:
October 15, 2020
Estimated Completion Date:
December 31, 2021

Study 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.

Connect with a study center

  • olivier EPAULARD

    Grenoble, 38043
    France

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.