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Evaluation of Quickly Diagnostic Saliva Tests for SARS-CoV-2

NCT ID: NCT04337424

Last Updated: 2020-11-04

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

Total Enrollment

627 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-13

Study Completion Date

2020-10-07

Brief Summary

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Coronavirus disease 2019 or COVID-19 is a highly contagious infectious disease. Symptoms of the disease are non-specific (fever, cough, dyspnea and fatigue), common with many seasonal viruses, which complicates the diagnosis. For mild forms, which represent the vast majority of cases, hospitalization is not necessary and treatment is symptomatic. However in more severe cases, hospitalization is required and sometimes even admission to an intensive care unit.

Several diagnostic tests are already available, but they require, in all cases, the intervention of qualified health personnel to carry out the sample, which includes a risk of contagion and an expensive and time-consuming laboratory analysis and reagents. These tests are therefore not very suitable for massive screenings.

We want to evaluate the performance of a detection test performed on a salivary sample in the diagnosis of SARS-CoV-2. This test will be non-invasive, performed without any analytical device and will restore its qualitative result "infected versus non-infected" in less than 1 hour (30min objective).

Detailed Description

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Study taking place at the Montpellier University Hospital, comparing a salivary sample group with active infection (participants) for SARS-COV2 with a salavary sample tested negative (cured, convalescent and negative) for SARS-COV2 (healthcare workers ,participants)

Conditions

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SARS-CoV-2

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants with active infection test to SARS-COV2

Sampling of saliva (1 to 2 ml)

Sampling salivary

Intervention Type DIAGNOSTIC_TEST

Collection of 1 to 2 ml of saliva

Convalescent participants for SARS-COV2

Sampling of saliva (1 to 2 ml)

Sampling salivary

Intervention Type DIAGNOSTIC_TEST

Collection of 1 to 2 ml of saliva

Participants cured to SARS-COV2

Sampling of saliva (1 to 2 ml)

Sampling salivary

Intervention Type DIAGNOSTIC_TEST

Collection of 1 to 2 ml of saliva

Participants with negative test to SARS-COV2

Sampling of saliva (1 to 2 ml)

Sampling salivary

Intervention Type DIAGNOSTIC_TEST

Collection of 1 to 2 ml of saliva

Interventions

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Sampling salivary

Collection of 1 to 2 ml of saliva

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

\- Control subjects (COV2- group): Participants ( Healthcare staff, patients and DRIVE participants) negative for SARS-CoV-2

\- Infected subjects (COV2 + group): Patients diagnosed positive for SARS-CoV-2 hospital staff known to be positive and coming to do a control PCR DRIVE participants.


\- Control subjects (COV2- group): Healthcare staff presumed and diagnosed negative for SARS-CoV-2

\- Infected subjects (COV2 + group): Patients diagnosed positive for SARS-CoV-2 hospital staff known to be positive and coming to do a control PCR

Exclusion Criteria

* Eligibility Criteria:


* Not affiliated with a French Social Security Systemscheme or equivalent system
* Persons deprived of their liberty, adult protected under guardianship or vulnerable persons
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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societe SkillCell - 97198 Jarry

UNKNOWN

Sponsor Role collaborator

CNRS Alcediag UMR9005 - societe Sys2Diag - 34184 Montpellier

UNKNOWN

Sponsor Role collaborator

University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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REYNES Jacques, PU PH

Role: PRINCIPAL_INVESTIGATOR

Montpellier Hospital

Locations

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UCH Montpellier

Montpellier, , France

Site Status

Countries

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France

Other Identifiers

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RECHMPL20_0170

Identifier Type: -

Identifier Source: org_study_id