Development of a Molecular Diagnostic Strategy for SARS-CoV2 Based on Saliva in the Context of the COVID-19 Pandemic

NCT ID: NCT04367545

Last Updated: 2020-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-16

Study Completion Date

2020-05-17

Brief Summary

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The objective of the study is to develop and validate a molecular diagnostic strategy (RT-ddPCR multiplex) of COVID-19 based on a saliva sample and alternative to the RT-qPCR method, in order to :

1. to compensate for the risk of a shortage of diagnostic kits, reagents and materials necessary for molecular diagnosis;
2. to increase the molecular diagnostic capacity of COVID-19 at the Rouen University Hospital;
3. and to have a method compatible with screening extended to populations at risk.

Detailed Description

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Conditions

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COVID RT-ddPCR Multiplex

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Patient with COVID-19 infection suspicion

Patient with COVID-19 infection suspicion are tested using standard diagnosis method

Group Type EXPERIMENTAL

Saliva collection

Intervention Type DIAGNOSTIC_TEST

Saliva collection will be done in addition to standard diagnosis collection (nasopharyngeal collection using swab)

Interventions

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Saliva collection

Saliva collection will be done in addition to standard diagnosis collection (nasopharyngeal collection using swab)

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Person aged over 18 years presenting to the COVID-19 consultation of the Rouen University Hospital for screening
* Person affiliated to a social security scheme

Exclusion Criteria

* Person objecting to participation in the research after reading information
* Person under the protection of justice,
* Person deprived of their liberty by administrative or judicial decision (guardianship, curatorship, etc.)
* Patient under guardianship or curatorship
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Rouen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thierry FREBOURG, Pr

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Rouen

Locations

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Rouen University Hospital

Rouen, , France

Site Status

Countries

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France

Other Identifiers

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2020/0094/OB

Identifier Type: -

Identifier Source: org_study_id