Detection of COVID-19 in Saliva Collection

Sars-CoV2 Clinical Trial

— SALICOV  

Official title:

Evaluation of the Performance of a Saliva Sample Versus a Nasopharyngeal Sample in the Diagnosis of COVID-19 by RT-PCR

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04386551
• Other study ID #: PI2020_843_0045
• Status: Completed
• Start date: May 6, 2020
• Est. completion date: August 5, 2020

Study information

• Verified date: December 2020
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Since December 2019, the world has faced a pandemic of COVID-19, an infectious disease caused by SARS-CoV-2, a virus that emerged in China. The reference diagnosis is based on the search for the SARS-COV-2 genome in the nasopharyngeal sample.

Carrying out this sample requires the competence of a healthcare professional and presents some inconveniences for the tested patient. Because saliva collection is simple, non-invasive, painless and inexpensive, and can be performed by poorly trained personnel, it could be an alternative to the reference nasopharyngeal sample. SARS-CoV2 detection in human saliva could be a potential diagnosis of COVID infection.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 501
• Est. completion date: August 5, 2020
• Est. primary completion date: August 5, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patient hospitalized at the Amiens CHU in a COVID-19 unit

• patient seen as outpatient in the area of infectious pathologies for COVID-19 infection

Exclusion Criteria:

• Patients under 18

• patients under guardianship or curators

Related Conditions & MeSH terms

• Nasopharyngeal Sample
• RT-PCR
• Saliva Collection
• Sars-CoV2

Locations

Country	Name	City	State
France	CHU Amiens	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection of SARS-CoV-2 RNA in the saliva sample	Detection of SARS-CoV-2 RNA in the saliva sample	day 1
Primary	Concordance between the Saliva sample and the nasonasopharyngeal sample SARS-CoV-2 RT-PCR results	Concordance between the Saliva sample and the nasonasopharyngeal sample SARS-CoV-2 RT-PCR results	day 1