Diagnostic Validation of Rapid Detection of the COVID-19 Causative Virus (SARS-CoV-2) in Saliva Samples by Mass Spectrometry

Covid19 Clinical Trial

— SALICOV  

Official title:

Validation Diagnostique de la détection Rapide du Virus SARS-CoV-2 Dans Des échantillons Salivaires Par spectrométrie de Masse

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04712175
• Other study ID #: LOCAL-COVID/2020/AS-01
• Status: Completed
• Start date: March 4, 2021
• Est. completion date: December 18, 2023

Study information

• Verified date: December 2023
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In order to control the COVID-19 pandemic, a policy for the diagnosis and screening of people likely to be infected with SARS-CoV-2 has been established The reference diagnostic test is RT-PCR on nasopharyngeal swab. Nasopharyngeal swabbing requires training, generates a risk of aerosolization and therefore viral transmission to the operator, and is unpleasant or even painful for the patient. RT-PCR is efficient, but time-consuming. It is therefore necessary to consider techniques that are less subject to difficulties of production and sampling, and less time-consuming. Tandem mass spectrometry on saliva samples is a promising option. A combined "mass spectrometry/saliva test" should provide faster results.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: December 18, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• The patient must not have opposed their inclusion in the study

• Patient presenting to the Walk-in Center for Emerging Biological Risks for SARS-CoV-2 screening by nasopharyngeal swab OR hospitalized in the Infectious and Tropical Diseases Department for severe SARS-CoV-2 infection, diagnosed by RT-PCR on nasopharyngeal sample, taken at Nîmes University Hospital, in the previous 24 hours.

Exclusion Criteria:

• Patient already included in the study

• The subject is in a period of exclusion determined by a previous study

• It is impossible to give the subject clear information

• The patient is under safeguard of justice or state guardianship

• Patient unable to give consent

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Diagnostic Test:
• Nasopharyngeal sampling
Swabs will be taken of nasopharyngeal samples for RT-PCR
• Saliva sampling
A 10ml saliva sample will collected in a sterile 60ml bottle for mass spectrometry and RT-PCR

Locations

Country	Name	City	State
France	CHU de Nîmes	Nîmes

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes	Technological Innovations for Detection and Diagnosis Laboratory

Country where clinical trial is conducted

France, 

References & Publications (1)

Gouveia D, Miotello G, Gallais F, Gaillard JC, Debroas S, Bellanger L, Lavigne JP, Sotto A, Grenga L, Pible O, Armengaud J. Proteotyping SARS-CoV-2 Virus from Nasopharyngeal Swabs: A Proof-of-Concept Focused on a 3 Min Mass Spectrometry Window. J Proteome Res. 2020 Nov 6;19(11):4407-4416. doi: 10.1021/acs.jproteome.0c00535. Epub 2020 Aug 5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection of SARS-CoV-2 on nasopharyngeal samples (gold standard)	RT-PCR	Day 0
Primary	Detection of SARS-CoV-2 on a saliva samples by mass spectrometry	tandem mass spectrometry test	Day 0
Secondary	Detection of SARS-CoV-2 on saliva samples via RT-PCR	RT-PCR	Day 0