Sars-CoV2SALICOVNCT04386551
Detection of COVID-19 in Saliva Collection
An observational study of Sars-CoV2 and RT-PCR, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sars-CoV2, RT-PCR, Saliva Collection
- How many people
- 501 participants
- Where
- 1 siteFrance
- Study dates
- 6 May 2020to 5 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Patients under 18
- patients under guardianship or curators
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Performance of a Saliva Sample Versus a Nasopharyngeal Sample in the Diagnosis of COVID-19 by RT-PCR
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
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of SARS-CoV-2 RNA in the saliva sample
Detection of SARS-CoV-2 RNA in the saliva sample
Measured: 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
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2020
- Study start6 May 2020
- Primary completion5 Aug 2020
- Study completion5 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sars-CoV2Studies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 501 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04386551
- Sponsor's protocol ID
- PI2020_843_0045
- Acronym
- SALICOV
- Status last verified
- Dec 2020
- First submitted
- 11 May 2020
- Last updated
- 11 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Performance of a Saliva Sample Versus a Nasopharyngeal Sample in the Diagnosis of COVID-19 by RT-PCR
- ClinicalTrials.gov ID
- NCT04386551
- Acronym / sponsor ID
- SALICOV / PI2020_843_0045
- Conditions
- Sars-CoV2, RT-PCR, Saliva Collection, Nasopharyngeal Sample
- Keywords
- Sars-CoV2, RT-PCR, Saliva collection, nasopharyngeal sample
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 501 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 6 May 2020 (actual)
- Primary completion
- 5 Aug 2020 (actual)
- Study completion
- 5 Aug 2020 (actual)
- First posted
- 13 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Patients under 18
- patients under guardianship or curators
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Detection of SARS-CoV-2 RNA in the saliva sample
Time frame: day 1
Detection of SARS-CoV-2 RNA in the saliva sample
Concordance between the Saliva sample and the nasonasopharyngeal sample SARS-CoV-2 RT-PCR results
Time frame: day 1
Concordance between the Saliva sample and the nasonasopharyngeal sample SARS-CoV-2 RT-PCR results
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sars-CoV2 and RT-PCR, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of SARS-CoV-2 RNA in the saliva sample (time frame: day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2020.