Clinical trial NCT04337424: Evaluation of Quickly Diagnostic Saliva Tests for SARS-CoV-2
Official title: Evaluation of Quickly Diagnostic Saliva Tests for SARS-CoV-2
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SARS-CoV-2
Keywords: Diagnosis test
Salivary sampling
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: societe SkillCell - 97198 Jarry
name: CNRS Alcediag UMR9005 - societe Sys2Diag - 34184 Montpellier
First posted: 2020-04-07
Enrollment: 627
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The samples size is 90 samples with active infection to SARS-COV2 and at least 90 with no active infection

Brief summary: 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: 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)

Eligibility criteria: 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.

Exclusion Criteria:

* Eligibility Criteria:

Inclusion Criteria:

- 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:

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

Primary outcomes:
measure: Specific detection of SARS-CoV-2 specific RNA
timeFrame: 1 day
Secondary outcomes:
measure: Analytical sensitivity of the LAMP test.
timeFrame: 1 day
measure: The correlation between the measurement of the assayed viral load (CT value) by the standard method and by the LAMP developed by SYS2DIAG / SKILLCELL.
timeFrame: 1 day
measure: Evaluation of the use of saliva samples compared to nasopharyngeal samples
timeFrame: 1 day
Other outcomes:
Locations:
city: Montpellier
country: France
facility: UCH Montpellier
Study officials:
affiliation: Montpellier Hospital
name: REYNES Jacques, PU PH
role: PRINCIPAL_INVESTIGATOR
References: