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

NCT05024461 | Unknown

• 1 other identifier: COVISAL
• Study Type: interventional
• Target: 1,159
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• Sensitivity of salivary test vs. nasopharyngeal test

  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

  1 day

• Perception of the tests by questionnaire (proportion of positive opinions)

  1 day

• Perception of the tests by questionnaire (proportion of negative opinions)

  1 day

• Positivity and negativity of the salivary test vs. symptomatology and associated terrain

  1 day

• Sensitivity and specificity analysis between the salivary test and the nasopharyngeal test according to the clinical context

  1 day

Study Arms (1)

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

Diagnostic Test: Salivary test for COVID19

Interventions

Salivary test for COVID19 DIAGNOSTIC_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

Patient with an indication for a COVID19 test

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with an indication to perform a COVID diagnostic test (symptomatology, contact case, systematic screening etc...)
• Men and women at least 3 years old

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier de Cayenne: lead

Study Sites (1)

General Hospital of Cayenne

Cayenne, 97306, French Guiana

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2021
• First Posted: August 27, 2021
• Study Start: August 10, 2020
• Primary Completion: November 12, 2020
• Study Completion: November 12, 2021
• Last Updated: August 27, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)