Evaluation of Quickly Diagnostic Saliva Tests for SARS-CoV-2 (EasyCoV)

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).

Study Overview

• Status: Completed
• Conditions: SARS-CoV-2
• Intervention / Treatment: Diagnostic test: Sampling salivary

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 Type: Observational
• Enrollment (Actual): 627

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • UCH Montpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Participants with active infection test to SARS-COV2; Sampling of saliva (1 to 2 ml)	Diagnostic test: Sampling salivary; Collection of 1 to 2 ml of saliva
Convalescent participants for SARS-COV2; Sampling of saliva (1 to 2 ml)	Diagnostic test: Sampling salivary; Collection of 1 to 2 ml of saliva
Participants cured to SARS-COV2; Sampling of saliva (1 to 2 ml)	Diagnostic test: Sampling salivary; Collection of 1 to 2 ml of saliva
Participants with negative test to SARS-COV2; Sampling of saliva (1 to 2 ml)	Diagnostic test: Sampling salivary; Collection of 1 to 2 ml of saliva

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Collaborators: societe SkillCell - 97198 Jarry; CNRS Alcediag UMR9005 - societe Sys2Diag - 34184 Montpellier
• Investigators: Principal Investigator: REYNES Jacques, PU PH, Montpellier Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 13, 2020
• Primary Completion (Actual): October 7, 2020
• Study Completion (Actual): October 7, 2020

Study Registration Dates

• First Submitted: April 5, 2020
• First Submitted That Met QC Criteria: April 5, 2020
• First Posted (Actual): April 7, 2020

Study Record Updates

• Last Update Posted (Actual): November 4, 2020
• Last Update Submitted That Met QC Criteria: November 3, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Diagnosis test; Salivary sampling
• Other Study ID Numbers: RECHMPL20_0170

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No