Detection of COVID-19 in Saliva Collection

NCT04386551 | Completed

• 1 other identifier: PI2020_843_0045
• Study Type: observational
• Target: 501
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Sars-CoV2; RT-PCR; Saliva collection; nasopharyngeal sample

Outcome Measures

Primary Outcomes (2)

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

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

  day 1

• 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

  day 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Patients under 18
• patients under guardianship or curators

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens

Amiens, 80480, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

nasopharyngeal sample and saliva sample

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2020
• First Posted: May 13, 2020
• Study Start: May 6, 2020
• Primary Completion: August 5, 2020
• Study Completion: August 5, 2020
• Last Updated: December 11, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)