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

NCT04597216 | Unknown

• 1 other identifier: 38RC20.289
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Interest of proteomic profile

  one day

• Stability of proteomic profile

  two days

Study Arms (1)

unique arm

OTHER

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

Device: sample of blood and saliva

Interventions

sample of blood and saliva DEVICE

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

unique arm

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• positive Covid-19 PCR
• clinical signs evocative of Covid-19

You may not qualify if:

• asymptomatic Covid-19 infection
• negative Covid-19 PCR
• acute respiratory infection
• none
• Phase 2
• suspicion of Covid-19
• sample for Covid-19 PCR planned or performed the same day
• past known Covid-19

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

olivier EPAULARD

Grenoble, 38043, France

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: October 13, 2020
• First Posted: October 22, 2020
• Study Start: October 15, 2020
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2021
• Last Updated: October 22, 2020

Record last verified: 2020-10

Locations

FR (1)