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

Covid19 Clinical Trial

— NanoDxCoV19  

Official title:

Exploration of Feasability of Blood and Saliva Proteomic Analysis Through Harvesting by Silica Matrix

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04597216
• Other study ID #: 38RC20.289
• Status: Recruiting
• Phase: N/A
• Start date: October 15, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: October 2020
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Covid19

Intervention

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

Locations

Country	Name	City	State
France	olivier EPAULARD	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of proteomic profile	MALDI-TOF mass spectrometric analysis of blood and saliva proteins to obtain a specific proteomic profile (obtained or not)	one day
Secondary	Interest of proteomic profile	Correlation between spectral analysis and severity of pathology at admission.	one day
Secondary	Stability of proteomic profile	Evaluation of mass spectrometric analysis reproductibility 48 hours after ambiant temperature conservation	two days