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

Completed

• Conditions: SARS-CoV-2
• Interventions: Diagnostic Test: Sampling salivary

• Registration Number: NCT04337424
• Lead Sponsor: University Hospital, Montpellier

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)

Study Timeline

• Status Verified: 2020-04
• Study First Submitted: 2020-04-05
• Study First Submitted QC: 2020-04-05
• Study First Posted: 2020-04-07
• Study Start: 2020-04-13
• Primary Completion: 2020-10-07
• Study Completion: 2020-10-07
• Last Update Submitted: 2020-11-03
• Last Update Posted: 2020-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 627

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Convalescent participants for SARS-COV2	Sampling salivary	Sampling of saliva (1 to 2 ml)
Participants cured to SARS-COV2	Sampling salivary	Sampling of saliva (1 to 2 ml)
Participants with active infection test to SARS-COV2	Sampling salivary	Sampling of saliva (1 to 2 ml)
Participants with negative test to SARS-COV2	Sampling salivary	Sampling of saliva (1 to 2 ml)

Primary Outcome Measures

Name	Time	Method
Specific detection of SARS-CoV-2 specific RNA	1 day	Detection by the LAMP method is to be corroborated with the reference method, RT-PCR on the same salivary sample. Only one sample is taken per subject participating in the study. The sample is divided into two aliquots which will be analyzed by LAMP and RT-PCR

Secondary Outcome Measures

Name	Time	Method
Evaluation of the use of saliva samples compared to nasopharyngeal samples	1 day	The RT-PCR results on these 2 types of samples and the LAMP results for the saliva samples will be compared with the patient diagnosis to assess the feasibility and performance of the saliva samples for the molecular diagnosis of SARS-CoV-2.
The correlation between the measurement of the assayed viral load (CT value) by the standard method and by the LAMP developed by SYS2DIAG / SKILLCELL.	1 day	A correlation between the viral loads measured on the same sample by RT-PCR and by LAMP will be carried out.
Analytical sensitivity of the LAMP test.	1 day	This test developed by SYS2DIAG / SKILLCELL must be able to detect a minimum viral load equivalent to that of the standard method on the same salivary sample.

Trial Locations

Locations (1)

UCH Montpellier; 🇫🇷 Montpellier, France