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CompletedNCT04386551SALICOVUpdated Dec 11, 2020

Detection of COVID-19 in Saliva Collection

An observational study in Sars-CoV2, RT-PCR and Saliva Collection, sponsored by Centre Hospitalier Universitaire, Amiens. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-12-11.

Sponsored by Centre Hospitalier Universitaire, Amiens · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
501
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Sars-CoV2
  • RT-PCR
  • Saliva Collection
  • Nasopharyngeal Sample

Keywords

  • Sars-CoV2
  • RT-PCR
  • Saliva collection
  • nasopharyngeal sample
03

In context

Lead sponsor

Centre Hospitalier Universitaire, Amiens is the lead sponsor of 576 studies on the registry; 178 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult ambulatory patients screened for SARS Cov 19 at the CHU Amiens COViD clinic will be included in the study. A double sample will be taken from the saliva and the nasopharynx in parallel using the same sample kit. This double sampling has no direct impact on conventional patient management.

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

Exclusion Criteria:

  • Patients under 18
  • patients under guardianship or curators
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
501 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna
06

What researchers measure

Primary outcomes

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

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

    Time frame: day 1

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

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

    Time frame: day 1

07

Study locations

1 site
  • CHU Amiens
    Amiens, 80480, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 11, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04386551
Lead sponsor
Centre Hospitalier Universitaire, Amiens
Responsible party
Sponsor
First posted
May 13, 2020
Start date
May 6, 2020
Primary completion
Aug 5, 2020
Completion
Aug 5, 2020
Last update
Dec 11, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.

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