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

Primary Purpose

Covid19

Status
Unknown status
Phase
Not Applicable
Locations
French Guiana
Study Type
Interventional
Intervention
Salivary test for COVID19
Sponsored by
Centre Hospitalier de Cayenne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Covid19

Eligibility Criteria

3 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • General Hospital of Cayenne

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patient with an indication for a COVID19 test

Arm Description

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

Outcomes

Primary Outcome Measures

Sensitivity of salivary test vs. nasopharyngeal test

Secondary Outcome Measures

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

Full Information

First Posted
August 16, 2021
Last Updated
August 26, 2021
Sponsor
Centre Hospitalier de Cayenne
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1. Study Identification

Unique Protocol Identification Number
NCT05024461
Brief Title
Comparison of Detection of SARS-CoV2 (COVID-19) Between Nasopharyngeal Swab Specimens and Those Obtained by Salivary Sputum
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 10, 2020 (Actual)
Primary Completion Date
November 12, 2020 (Actual)
Study Completion Date
November 12, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier de Cayenne

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1159 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patient with an indication for a COVID19 test
Arm Type
Experimental
Arm Description
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
Intervention Type
Diagnostic Test
Intervention Name(s)
Salivary test for COVID19
Intervention Description
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
Primary Outcome Measure Information:
Title
Sensitivity of salivary test vs. nasopharyngeal test
Time Frame
1 day
Secondary Outcome Measure Information:
Title
- 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
Title
Perception of the tests by questionnaire (proportion of positive opinions)
Time Frame
1 day
Title
Perception of the tests by questionnaire (proportion of negative opinions)
Time Frame
1 day
Title
Positivity and negativity of the salivary test vs. symptomatology and associated terrain
Time Frame
1 day
Title
Sensitivity and specificity analysis between the salivary test and the nasopharyngeal test according to the clinical context
Description
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)
Time Frame
1 day
Title
Description of the aspect of the saliva collected: mucous or fluid
Description
Description of the analytical criteria of the saliva sample
Time Frame
1 day
Title
Volume of saliva collected (mL)
Description
Description of the analytical criteria of the saliva sample: (pipette measurement, if the saliva is not fluid, pipette measurement after vortexing for 1 min)
Time Frame
1 day
Title
Description of the analytical criteria of the saliva sample:pre-analytical treatments if necessary
Time Frame
1 day
Title
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
Title
- Sensitivity of salivary test vs nasopharyngeal test with strong positives (3 genes detected)
Time Frame
1 day
Title
- Specificity of salivary test vs nasopharyngeal test with strong positives (3 genes detected)
Time Frame
1 day
Title
- Sensitivity of salivary test vs nasopharyngeal test with weak positives (1 gene detected)
Time Frame
1 day
Title
- Specificity of salivary test vs nasopharyngeal test with weak positives (1 gene detected)
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
General Hospital of Cayenne
City
Cayenne
ZIP/Postal Code
97306
Country
French Guiana

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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