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

SARS-CoV-2 Clinical Trial

— EasyCoV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04337424
• Other study ID #: RECHMPL20_0170
• Status: Completed
• Start date: April 13, 2020
• Est. completion date: October 7, 2020

Study information

• Verified date: April 2020
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 627
• Est. completion date: October 7, 2020
• Est. primary completion date: October 7, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• SARS-CoV-2

Intervention

Diagnostic Test:
• Sampling salivary
Collection of 1 to 2 ml of saliva

Locations

Country	Name	City	State
France	UCH Montpellier	Montpellier

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Montpellier	CNRS Alcediag UMR9005 - societe Sys2Diag - 34184 Montpellier, societe SkillCell - 97198 Jarry

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Specific detection of SARS-CoV-2 specific RNA	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	1 day
Secondary	Analytical sensitivity of the LAMP test.	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.	1 day
Secondary	The correlation between the measurement of the assayed viral load (CT value) by the standard method and by the LAMP developed by SYS2DIAG / SKILLCELL.	A correlation between the viral loads measured on the same sample by RT-PCR and by LAMP will be carried out.	1 day
Secondary	Evaluation of the use of saliva samples compared to nasopharyngeal samples	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.	1 day