NCT04337424

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 627 (actual)
• Sponsor: University Hospital, Montpellier · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Accepted

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)

Conditions

• SARS-CoV-2

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Sampling salivary	Collection of 1 to 2 ml of saliva

Timeline

• Start date: 2020-04-13
• Primary completion: 2020-10-07
• Completion: 2020-10-07
• First posted: 2020-04-07
• Last updated: 2020-11-04

Locations

1 site across 1 country: France