Skip to content

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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04597216
Acronym
NanoDxCoV19
Enrollment
200
Registered
2020-10-22
Start date
2020-10-15
Completion date
2021-12-31
Last updated
2020-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19

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.

Interventions

DEVICEsample of blood and saliva

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

Sponsors

University Hospital, Grenoble
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Feasibility of proteomic profileone dayMALDI-TOF mass spectrometric analysis of blood and saliva proteins to obtain a specific proteomic profile (obtained or not)

Secondary

MeasureTime frameDescription
Interest of proteomic profileone dayCorrelation between spectral analysis and severity of pathology at admission.
Stability of proteomic profiletwo daysEvaluation of mass spectrometric analysis reproductibility 48 hours after ambiant temperature conservation

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026