Covid19SALICOVNCT04712175
Diagnostic Validation of Rapid Detection of the COVID-19 Causative Virus (SARS-CoV-2) in Saliva Samples by Mass Spectrometry
An observational study of Covid19, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
In order to control the COVID-19 pandemic, a policy for the diagnosis and screening of people likely to be infected with SARS-CoV-2 has been established The reference diagnostic test is RT-PCR on nasopharyngeal swab. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Nasopharyngeal sampling and Saliva sampling
- How many people
- 250 participants
- Where
- 1 siteFrance
- Study dates
- 4 Mar 2021to 18 Dec 2023
- 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: Adults presenting to the Walk-in Center for Emerging Biological Risks of the Nîmes University Hospital for screening for SARS-CoV-2 infection or who are hospitalized at the Infectious and Tropical Diseases Department for severe infection with SARS-CoV-2.
Who may be able to join
- The patient must not have opposed their inclusion in the study
- Patient presenting to the Walk-in Center for Emerging Biological Risks for SARS-CoV-2 screening by nasopharyngeal swab OR hospitalized in the Infectious and Tropical Diseases Department for severe SARS-CoV-2 infection, diagnosed by RT-PCR on nasopharyngeal sample, taken at Nîmes University Hospital, in the previous 24 hours.
Who cannot join
- Patient already included in the study
- The subject is in a period of exclusion determined by a previous study
- It is impossible to give the subject clear information
- The patient is under safeguard of justice or state guardianship
- Patient unable to give consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation Diagnostique de la détection Rapide du Virus SARS-CoV-2 Dans Des échantillons Salivaires Par spectrométrie de Masse
In order to control the COVID-19 pandemic, a policy for the diagnosis and screening of people likely to be infected with SARS-CoV-2 has been established The reference diagnostic test is RT-PCR on nasopharyngeal swab. Nasopharyngeal swabbing requires training, generates a risk of aerosolization and therefore viral transmission to the operator, and is unpleasant or even painful for the patient. RT-PCR is efficient, but time-consuming. It is therefore necessary to consider techniques that are less subject to difficulties of production and sampling, and less time-consuming. Tandem mass spectrometry on saliva samples is a promising option. A combined "mass spectrometry/saliva test" should provide faster results.
- Conditions
- Covid19
- Being tested
- Nasopharyngeal sampling, Saliva sampling
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasopharyngeal samplingDiagnostic test
Swabs will be taken of nasopharyngeal samples for RT-PCR
Saliva samplingDiagnostic test
A 10ml saliva sample will collected in a sterile 60ml bottle for mass spectrometry and RT-PCR
| Study group | Role | What they receive |
|---|---|---|
| Patients with SARS-CoV-2 infection | Not described Receives: Diagnostic Test: Nasopharyngeal sampling; Diagnostic Test: Saliva sampling | |
| Patients without SARS-CoV-2 infection | Not described Receives: Diagnostic Test: Nasopharyngeal sampling; Diagnostic Test: Saliva sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of SARS-CoV-2 on nasopharyngeal samples (gold standard)
RT-PCR
Measured: Day 0
Detection of SARS-CoV-2 on a saliva samples by mass spectrometry
tandem mass spectrometry test
Measured: Day 0
Secondary outcomes (1)
Detection of SARS-CoV-2 on saliva samples via RT-PCR
RT-PCR
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2021
- Study start4 Mar 2021
- Primary completion31 Dec 2022
- Study completion18 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe 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-control
- Time perspective
- Prospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Collaborators
- Technological Innovations for Detection and Diagnosis Laboratory
- Responsible party
- Sponsor
- Investigators
- Albert Sotto, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04712175
- Sponsor's protocol ID
- LOCAL-COVID/2020/AS-01
- Acronym
- SALICOV
- Status last verified
- Dec 2023
- First submitted
- 12 Jan 2021
- Last updated
- 29 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gouveia D, Miotello G, Gallais F, Gaillard JC, Debroas S, Bellanger L, Lavigne JP, Sotto A, Grenga L, Pible O, Armengaud J. Proteotyping SARS-CoV-2 Virus from Nasopharyngeal Swabs: A Proof-of-Concept Focused on a 3 Min Mass Spectrometry Window. J Proteome Res. 2020 Nov 6;19(11):4407-4416. doi: 10.1021/acs.jproteome.0c00535. Epub 2020 Aug 5.
PubMed 32697082
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation Diagnostique de la détection Rapide du Virus SARS-CoV-2 Dans Des échantillons Salivaires Par spectrométrie de Masse
- ClinicalTrials.gov ID
- NCT04712175
- Acronym / sponsor ID
- SALICOV / LOCAL-COVID/2020/AS-01
- Conditions
- Covid19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Collaborators
- Technological Innovations for Detection and Diagnosis Laboratory
- Study start
- 4 Mar 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 18 Dec 2023 (actual)
- First posted
- 15 Jan 2021 (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.
In order to control the COVID-19 pandemic, a policy for the diagnosis and screening of people likely to be infected with SARS-CoV-2 has been established The reference diagnostic test is RT-PCR on nasopharyngeal swab. Nasopharyngeal swabbing requires training, generates a risk of aerosolization and therefore viral transmission to the operator, and is unpleasant or even painful for the patient. RT-PCR is efficient, but time-consuming. It is therefore necessary to consider techniques that are less subject to difficulties of production and sampling, and less time-consuming. Tandem mass spectrometry on saliva samples is a promising option. A combined "mass spectrometry/saliva test" should provide faster results.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with SARS-CoV-2 infection | – | Diagnostic Test: Nasopharyngeal sampling, Diagnostic Test: Saliva sampling |
| Patients without SARS-CoV-2 infection | – | Diagnostic Test: Nasopharyngeal sampling, Diagnostic Test: Saliva sampling |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults presenting to the Walk-in Center for Emerging Biological Risks of the Nîmes University Hospital for screening for SARS-CoV-2 infection or who are hospitalized at the Infectious and Tropical Diseases Department for severe infection with SARS-CoV-2.
Key inclusion criteria (2 listed)
- The patient must not have opposed their inclusion in the study
- Patient presenting to the Walk-in Center for Emerging Biological Risks for SARS-CoV-2 screening by nasopharyngeal swab OR hospitalized in the Infectious and Tropical Diseases Department for severe SARS-CoV-2 infection, diagnosed by RT-PCR on nasopharyngeal sample, taken at Nîmes University Hospital, in the previous 24 hours.
Key exclusion criteria (5 listed)
- Patient already included in the study
- The subject is in a period of exclusion determined by a previous study
- It is impossible to give the subject clear information
- The patient is under safeguard of justice or state guardianship
- Patient unable to give consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nasopharyngeal samplingSwabs will be taken of nasopharyngeal samples for RT-PCR | Diagnostic test | Patients with SARS-CoV-2 infection, Patients without SARS-CoV-2 infection |
| Saliva samplingA 10ml saliva sample will collected in a sterile 60ml bottle for mass spectrometry and RT-PCR | Diagnostic test | Patients with SARS-CoV-2 infection, Patients without SARS-CoV-2 infection |
Primary outcome
Detection of SARS-CoV-2 on nasopharyngeal samples (gold standard)
Time frame: Day 0
RT-PCR
Detection of SARS-CoV-2 on a saliva samples by mass spectrometry
Time frame: Day 0
tandem mass spectrometry test
1 secondary outcome
Detection of SARS-CoV-2 on saliva samples via RT-PCR
Time frame: Day 0
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 29 Dec 2023.
- Background: PubMed 32697082Gouveia D, Miotello G, Gallais F, Gaillard JC, Debroas S, Bellanger L, Lavigne JP, Sotto A, Grenga L, Pible O, Armengaud J. Proteotyping SARS-CoV-2 Virus from Nasopharyngeal Swabs: A Proof-of-Concept Focused on a 3 Min Mass Spectrometry Window. J Proteome Res. 2020 Nov 6;19(11):4407-4416. doi: 10.1021/acs.jproteome.0c00535. Epub 2020 Aug 5.
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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.
Albert Sotto principal investigator
Centre Hospitalier Universitaire de Nīmes
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 Covid19, run by Centre Hospitalier Universitaire de Nīmes 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 5 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 29 Dec 2023. 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 on nasopharyngeal samples (gold standard) (time frame: Day 0). 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?
On the ClinicalTrials.gov record for NCT04712175, which also lists 1 linked publication.
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 29 Dec 2023.