Comparison of Detection of SARS-CoV2 (COVID-19) Between Nasopharyngeal Swab Specimens and Those Obtained by Salivary Sputum

Covid19 Clinical Trial

— COVISAL  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05024461
• Other study ID #: COVISAL
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 10, 2020
• Est. completion date: November 12, 2021

Study information

• Verified date: August 2021
• Source: Centre Hospitalier de Cayenne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1159
• Est. completion date: November 12, 2021
• Est. primary completion date: November 12, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years and older

Eligibility

Inclusion Criteria:

• Patient with an indication to perform a COVID diagnostic test (symptomatology, contact case, systematic screening etc...)

• Men and women at least 3 years old

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Covid19

Intervention

Diagnostic Test:
• Salivary test for COVID19
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

Locations

Country	Name	City	State
French Guiana	General Hospital of Cayenne	Cayenne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier de Cayenne

Country where clinical trial is conducted

French Guiana, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity of salivary test vs. nasopharyngeal test		1 day
Secondary	- 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		1 day
Secondary	Perception of the tests by questionnaire (proportion of positive opinions)		1 day
Secondary	Perception of the tests by questionnaire (proportion of negative opinions)		1 day
Secondary	Positivity and negativity of the salivary test vs. symptomatology and associated terrain		1 day
Secondary	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)	1 day
Secondary	Description of the aspect of the saliva collected: mucous or fluid	Description of the analytical criteria of the saliva sample	1 day
Secondary	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)	1 day
Secondary	Description of the analytical criteria of the saliva sample:pre-analytical treatments if necessary		1 day
Secondary	Number of Cycle threeshold for the first analysis (done at the Cayenne hospital) and the second analysis (done at the university hospital of Caen)		1 day
Secondary	- Sensitivity of salivary test vs nasopharyngeal test with strong positives (3 genes detected)		1 day
Secondary	- Specificity of salivary test vs nasopharyngeal test with strong positives (3 genes detected)		1 day
Secondary	- Sensitivity of salivary test vs nasopharyngeal test with weak positives (1 gene detected)		1 day
Secondary	- Specificity of salivary test vs nasopharyngeal test with weak positives (1 gene detected)		1 day