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OpenTrials
Completed

NCT Number: NCT04712175

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

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.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Nîmes

Nîmes, France

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Nasopharyngeal sampling

Diagnostic Test

Swabs will be taken of nasopharyngeal samples for RT-PCR

saliva sampling

Diagnostic Test

A 10ml saliva sample will collected in a sterile 60ml bottle for mass spectrometry and RT-PCR

Primary outcomes

  1. Detection of SARS-CoV-2 on nasopharyngeal samples (gold standard)

    Time frame: Day 0

    RT-PCR

  2. Detection of SARS-CoV-2 on a saliva samples by mass spectrometry

    Time frame: Day 0

    tandem mass spectrometry test

Secondary outcomes

  1. Detection of SARS-CoV-2 on saliva samples via RT-PCR

    Time frame: Day 0

    RT-PCR

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Collaborators

  • Technological Innovations for Detection and Diagnosis Laboratory

Registry information

Official study title

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

Acronym: SALICOV

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Jan 15, 2021
Registry last updated
Dec 29, 2023

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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