Sars-CoV2 Clinical Trial
— SALICOVOfficial title:
Evaluation of the Performance of a Saliva Sample Versus a Nasopharyngeal Sample in the Diagnosis of COVID-19 by RT-PCR
NCT number | NCT04386551 |
Other study ID # | PI2020_843_0045 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 6, 2020 |
Est. completion date | August 5, 2020 |
Verified date | December 2020 |
Source | Centre Hospitalier Universitaire, Amiens |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 501 |
Est. completion date | August 5, 2020 |
Est. primary completion date | August 5, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | CHU Amiens | Amiens |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire, Amiens |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Detection of SARS-CoV-2 RNA in the saliva sample | Detection of SARS-CoV-2 RNA in the saliva sample | day 1 | |
Primary | 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 |
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