NCT04712175

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 15, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

March 4, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 18, 2023

Completed
Last Updated

December 29, 2023

Status Verified

December 1, 2023

Enrollment Period

1.8 years

First QC Date

January 12, 2021

Last Update Submit

December 28, 2023

Conditions

Covid19

Outcome Measures

Primary Outcomes (2)

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

    RT-PCR

    Day 0

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

    tandem mass spectrometry test

    Day 0

Secondary Outcomes (1)

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

    Day 0

Study Arms (2)

Patients with SARS-CoV-2 infection

Diagnostic Test: Nasopharyngeal samplingDiagnostic Test: Saliva sampling

Patients without SARS-CoV-2 infection

Diagnostic Test: Nasopharyngeal samplingDiagnostic Test: Saliva sampling

Interventions

Nasopharyngeal samplingDIAGNOSTIC_TEST

Swabs will be taken of nasopharyngeal samples for RT-PCR

Patients with SARS-CoV-2 infectionPatients without SARS-CoV-2 infection
Saliva samplingDIAGNOSTIC_TEST

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

Patients with SARS-CoV-2 infectionPatients without SARS-CoV-2 infection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • Patient already included in the 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nîmes

Nîmes, France

Location

Related 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.

    PMID: 32697082BACKGROUND

Biospecimen

Retention: NONE RETAINED

Anonymized saliva samples of patients with positive RT-PCR results.

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Albert Sotto

    Centre Hospitalier Universitaire de Nīmes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2021

First Posted

January 15, 2021

Study Start

March 4, 2021

Primary Completion

December 31, 2022

Study Completion

December 18, 2023

Last Updated

December 29, 2023

Record last verified: 2023-12

Locations

FR(1)