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SALICOV: Detection of COVID-19 in Saliva Collection

Sponsor
Centre Hospitalier Universitaire, Amiens (Other)
Overall Status
Completed
CT.gov ID
NCT04386551
Collaborator
(none)
501
Enrollment
1
Location
3
Actual Duration (Months)
167.6
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    501 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Evaluation of the Performance of a Saliva Sample Versus a Nasopharyngeal Sample in the Diagnosis of COVID-19 by RT-PCR
    Actual Study Start Date :
    May 6, 2020
    Actual Primary Completion Date :
    Aug 5, 2020
    Actual Study Completion Date :
    Aug 5, 2020

    Outcome Measures

    Primary Outcome Measures

    1. Detection of SARS-CoV-2 RNA in the saliva sample [day 1]

      Detection of SARS-CoV-2 RNA in the saliva sample

    2. Concordance between the Saliva sample and the nasonasopharyngeal sample SARS-CoV-2 RT-PCR results [day 1]

      Concordance between the Saliva sample and the nasonasopharyngeal sample SARS-CoV-2 RT-PCR results

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHU Amiens Amiens France 80480

    Sponsors and Collaborators

    • Centre Hospitalier Universitaire, Amiens

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Centre Hospitalier Universitaire, Amiens
    ClinicalTrials.gov Identifier:
    NCT04386551
    Other Study ID Numbers:
    • PI2020_843_0045
    First Posted:
    May 13, 2020
    Last Update Posted:
    Dec 11, 2020
    Last Verified:
    Dec 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Centre Hospitalier Universitaire, Amiens
    Sars-CoV2
    RT-PCR
    Saliva collection
    nasopharyngeal sample

    Study Results

    No Results Posted as of Dec 11, 2020