Exploration of Feasability of Blood and Saliva Proteomic... | NCT04597216

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

NCT04597216

Sponsor

University Hospital, Grenoble

Status

Unknown status

Last Update Posted

Oct 22, 2020Actual

Enrollment

200Estimated

Phase

Not Applicable

Conditions

Covid19

Interventions

sample of blood and saliva

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 15, 2020Estimated

Primary Completion Date

Dec 31, 2020Estimated

Completion Date

Dec 31, 2021Estimated

First Submitted Date

Oct 13, 2020

First Submission Date that Met QC Criteria

Oct 20, 2020

First Posted Date

Oct 22, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 20, 2020

Last Update Posted Date

Oct 22, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Interest of proteomic profile	Correlation between spectral analysis and severity of pathology at admission.	one day
Stability of proteomic profile	Evaluation of mass spectrometric analysis reproductibility 48 hours after ambiant temperature conservation

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
olivier EPAULARD	Recruiting	Grenoble		38043	France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided