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Completed

NCT Number: NCT04337424

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

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).

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Key information

Conditions

SARS-CoV-2

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UCH Montpellier

Montpellier, 34295, France

About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sampling salivary

Diagnostic Test

Collection of 1 to 2 ml of saliva

Primary outcomes

  1. Specific detection of SARS-CoV-2 specific RNA

    Time frame: 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 outcomes

  1. Analytical sensitivity of the LAMP test.

    Time frame: 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.

  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.

    Time frame: 1 day

    A correlation between the viral loads measured on the same sample by RT-PCR and by LAMP will be carried out.

  3. Evaluation of the use of saliva samples compared to nasopharyngeal samples

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Collaborators

  • CNRS Alcediag UMR9005 - societe Sys2Diag - 34184 Montpellier
  • societe SkillCell - 97198 Jarry

Registry information

Acronym: EasyCoV

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 7, 2020
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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