Covid19COVISALNCT05024461
Comparison of Detection of SARS-CoV2 (COVID-19) Between Nasopharyngeal Swab Specimens and Those Obtained by Salivary Sputum
A study testing Salivary test for COVID19 in people with Covid19, run by Centre Hospitalier de Cayenne at 1 site in French Guiana.
Trial summary
Multicenter observational study of diagnostic test validation (Research Involving the Human Person, type 3) In addition to the diagnosis by the reference method (nasopharyngeal swab), the patient will be asked to provide a saliva sample via a salivary spit. Read more about this study
- Who is it for?
- Ages 3 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- Salivary test for COVID19
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,159 participants
- Where
- 1 siteFrench Guiana
- Study dates
- 10 Aug 2020to 12 Nov 2021
- Phase
- Interventional
- 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 3 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patient with an indication to perform a COVID diagnostic test (symptomatology, contact case, systematic screening etc...)
- Men and women at least 3 years old
Who cannot join
- Refusal of the patient or his legal representative,
- Taking treatments that reduce salivary volume (anticholinergic activity)
- Impossibility to perform the nasopharyngeal test
- Patient under guardianship or curatorship, persons placed under protective measures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Results, Feasibility and Acceptability of Molecular Detection of SARS-CoV2 Between Nasopharyngeal Swab Specimens Recovered in Virological Transport Medium and Those Obtained by Salivary Sputum
Multicenter observational study of diagnostic test validation (Research Involving the Human Person, type 3) In addition to the diagnosis by the reference method (nasopharyngeal swab), the patient will be asked to provide a saliva sample via a salivary spit. The clinical circumstances of the diagnosis, the age of the patient, the associated terrain (diabetes, immunodepression, pregnancy) will be noted. The nasopharyngeal and saliva samples will be analyzed in Cayenne and the remaining samples will be frozen and stored at the CRB before being sent to the University Hospital of Caen for analysis and concordance verification.
The expected benefits are:
Read more
Possibility of repeating tests in the same person more easily due to the absence of pain and thus reduce the barriers to diagnosis and screening.
Possibility of self-sampling, which could simply be sent to the laboratory, which would relieve the diagnostic sites that mobilize staff and require a fairly heavy organization. Avoid long waiting lines that can be an obstacle and lead to a renunciation of the diagnosis.
- Conditions
- Covid19
- Being tested
- Salivary test for COVID19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salivary test for COVID19Diagnostic test
Results of nasopharyngeal and salivary samples taken at the Cayenne hospital and the Caen university center,
- Pre-analytical particularities and analytical particularities
- Cycle threeshold
- Demographic variables
- Clinical variables
- Clinical criteria
- Questionnaire on the perception of the 2 sampling methods
| Study group | Role | What they receive |
|---|---|---|
| Patient with an indication for a COVID19 test | Experimental | The persons included will be those who have an indication for a COVID 19 test and who present themselves at the Cayenne hospital and during the screening missions organised by the Red Cross and Médecin du Monde during the COVID 19 epidemic in the territory Receives: Diagnostic Test: Salivary test for COVID19 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of salivary test vs. nasopharyngeal test
Measured: 1 day
Secondary outcomes (13)
- Proportion of analyses not performed on salivary samples for the following reasons (vs. number of salivary sample analyses performed): o Insufficient quantity of biological sample, o Inability to collect the sample
Measured: 1 day
Perception of the tests by questionnaire (proportion of positive opinions)
Measured: 1 day
Perception of the tests by questionnaire (proportion of negative opinions)
Measured: 1 day
Positivity and negativity of the salivary test vs. symptomatology and associated terrain
Measured: 1 day
Sensitivity and specificity analysis between the salivary test and the nasopharyngeal test according to the clinical context
Sensitivity and specificity analysis between the salivary test and the nasopharyngeal test according to the time between the samples and the onset of symptoms, the time between the samples and the contact with an index case, the known immunodepression and the clinical context (diabetes, pregnancy)
Measured: 1 day
Description of the aspect of the saliva collected: mucous or fluid
Description of the analytical criteria of the saliva sample
Measured: 1 day
Volume of saliva collected (mL)
Description of the analytical criteria of the saliva sample: (pipette measurement, if the saliva is not fluid, pipette measurement after vortexing for 1 min)
Measured: 1 day
Description of the analytical criteria of the saliva sample:pre-analytical treatments if necessary
Measured: 1 day
Number of Cycle threeshold for the first analysis (done at the Cayenne hospital) and the second analysis (done at the university hospital of Caen)
Measured: 1 day
- Sensitivity of salivary test vs nasopharyngeal test with strong positives (3 genes detected)
Measured: 1 day
- Specificity of salivary test vs nasopharyngeal test with strong positives (3 genes detected)
Measured: 1 day
- Sensitivity of salivary test vs nasopharyngeal test with weak positives (1 gene detected)
Measured: 1 day
- Specificity of salivary test vs nasopharyngeal test with weak positives (1 gene detected)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2021
- Study start10 Aug 2020
- Primary completion12 Nov 2020
- Study completion12 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Cayenne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05024461
- Sponsor's protocol ID
- COVISAL
- Acronym
- COVISAL
- Status last verified
- Aug 2021
- First submitted
- 16 Aug 2021
- Last updated
- 27 Aug 2021
- 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 27 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Results, Feasibility and Acceptability of Molecular Detection of SARS-CoV2 Between Nasopharyngeal Swab Specimens Recovered in Virological Transport Medium and Those Obtained by Salivary Sputum
- ClinicalTrials.gov ID
- NCT05024461
- Acronym / sponsor ID
- COVISAL / COVISAL
- Conditions
- Covid19
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,159 participants (actual)
- Lead sponsor
- Centre Hospitalier de CayenneUniversity, hospital or other
- Study start
- 10 Aug 2020 (actual)
- Primary completion
- 12 Nov 2020 (actual)
- Study completion
- 12 Nov 2021 (estimated)
- First posted
- 27 Aug 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.
Multicenter observational study of diagnostic test validation (Research Involving the Human Person, type 3) In addition to the diagnosis by the reference method (nasopharyngeal swab), the patient will be asked to provide a saliva sample via a salivary spit. The clinical circumstances of the diagnosis, the age of the patient, the associated terrain (diabetes, immunodepression, pregnancy) will be noted. The nasopharyngeal and saliva samples will be analyzed in Cayenne and the remaining samples will be frozen and stored at the CRB before being sent to the University Hospital of Caen for analysis and concordance verification.
The expected benefits are:
Possibility of repeating tests in the same person more easily due to the absence of pain and thus reduce the barriers to diagnosis and screening.
Possibility of self-sampling, which could simply be sent to the laboratory, which would relieve the diagnostic sites that mobilize staff and require a fairly heavy organization. Avoid long waiting lines that can be an obstacle and lead to a renunciation of the diagnosis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with an indication for a COVID19 test | Experimental | Diagnostic Test: Salivary test for COVID19The persons included will be those who have an indication for a COVID 19 test and who present themselves at the Cayenne hospital and during the screening missions organised by the Red Cross and Médecin du Monde during the COVID 19 epidemic in the territory |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patient with an indication to perform a COVID diagnostic test (symptomatology, contact case, systematic screening etc...)
- Men and women at least 3 years old
Key exclusion criteria (4 listed)
- Refusal of the patient or his legal representative,
- Taking treatments that reduce salivary volume (anticholinergic activity)
- Impossibility to perform the nasopharyngeal test
- Patient under guardianship or curatorship, persons placed under protective measures
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 |
|---|---|---|
| Salivary test for COVID19Results of nasopharyngeal and salivary samples taken at the Cayenne hospital and the Caen university center, * Pre-analytical particularities and analytical particularities * Cycle threeshold * Demographic variables * Clinical variables * Clinical criteria * Questionnaire on the perception of the 2 sampling methods | Diagnostic test | Patient with an indication for a COVID19 test |
Primary outcome
Sensitivity of salivary test vs. nasopharyngeal test
Time frame: 1 day
13 secondary outcomes
- Proportion of analyses not performed on salivary samples for the following reasons (vs. number of salivary sample analyses performed): o Insufficient quantity of biological sample, o Inability to collect the sample
Time frame: 1 day
Perception of the tests by questionnaire (proportion of positive opinions)
Time frame: 1 day
Perception of the tests by questionnaire (proportion of negative opinions)
Time frame: 1 day
Positivity and negativity of the salivary test vs. symptomatology and associated terrain
Time frame: 1 day
Sensitivity and specificity analysis between the salivary test and the nasopharyngeal test according to the clinical context
Time frame: 1 day
Description of the aspect of the saliva collected: mucous or fluid
Time frame: 1 day
Volume of saliva collected (mL)
Time frame: 1 day
Description of the analytical criteria of the saliva sample:pre-analytical treatments if necessary
Time frame: 1 day
Number of Cycle threeshold for the first analysis (done at the Cayenne hospital) and the second analysis (done at the university hospital of Caen)
Time frame: 1 day
- Sensitivity of salivary test vs nasopharyngeal test with strong positives (3 genes detected)
Time frame: 1 day
- Specificity of salivary test vs nasopharyngeal test with strong positives (3 genes detected)
Time frame: 1 day
- Sensitivity of salivary test vs nasopharyngeal test with weak positives (1 gene detected)
Time frame: 1 day
- Specificity of salivary test vs nasopharyngeal test with weak positives (1 gene detected)
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2021.
- 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?
A study testing Salivary test for COVID19 in people with Covid19, run by Centre Hospitalier de Cayenne at 1 site in French Guiana.
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 4 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: status not confirmed, as of the sponsor's last update on 27 Aug 2021. 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 French Guiana. 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?
Results are not available in the source record.
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?
Sensitivity of salivary test vs. nasopharyngeal test (time frame: 1 day). 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 27 Aug 2021; AzTrials last refreshed its copy on 8 Nov 2026.