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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04712175
Recruitment Status : Recruiting
First Posted : January 15, 2021
Last Update Posted : January 25, 2022
Sponsor:
Collaborator:
Technological Innovations for Detection and Diagnosis Laboratory
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Covid19 Diagnostic Test: Nasopharyngeal sampling Diagnostic Test: Saliva sampling

Study Design
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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Validation Diagnostique de la détection Rapide du Virus SARS-CoV-2 Dans Des échantillons Salivaires Par spectrométrie de Masse
Actual Study Start Date : March 4, 2021
Actual Primary Completion Date : August 5, 2021
Estimated Study Completion Date : March 30, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Patients with SARS-CoV-2 infection Diagnostic Test: Nasopharyngeal sampling
Swabs will be taken of nasopharyngeal samples for RT-PCR

Diagnostic Test: Saliva sampling
A 10ml saliva sample will collected in a sterile 60ml bottle for mass spectrometry and RT-PCR
Patients without SARS-CoV-2 infection Diagnostic Test: Nasopharyngeal sampling
Swabs will be taken of nasopharyngeal samples for RT-PCR

Diagnostic Test: Saliva sampling
A 10ml saliva sample will collected in a sterile 60ml bottle for mass spectrometry and RT-PCR


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  1. Detection of SARS-CoV-2 on saliva samples via RT-PCR [ Time Frame: Day 0 ]
    RT-PCR


Biospecimen Retention:   None Retained
Anonymized saliva samples of patients with positive RT-PCR results.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults presenting to the Walk-in Center for Emerging Biological Risks of the Nîmes University Hospital for screening for SARS-CoV-2 infection or who are hospitalized at the Infectious and Tropical Diseases Department for severe infection with SARS-CoV-2.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04712175


Contacts
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Contact: Albert Sotto 04.66.68.41.49 albert.sotto@chu-nimes.fr

Locations
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France
CHU de Nîmes Recruiting
Nîmes, France
Contact: Anissa Megzari    04.66.68.42.36    drc@chu-nimes.fr   
Principal Investigator: Albert Sotto         
Sub-Investigator: Paul Loubet         
Sub-Investigator: Didier Laureillard         
Sub-Investigator: Jean-Philippe Lavigne         
Sub-Investigator: Jean Armengaud         
Sub-Investigator: Lucia Grenga         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Technological Innovations for Detection and Diagnosis Laboratory
Investigators
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Principal Investigator: Albert Sotto Centre Hospitalier Universitaire de Nīmes
More Information
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Publications:

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Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT04712175    
Other Study ID Numbers: LOCAL-COVID/2020/AS-01
First Posted: January 15, 2021    Key Record Dates
Last Update Posted: January 25, 2022
Last Verified: January 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases