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

NCT ID: NCT05024461

Last Updated: 2021-08-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 1159 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-10
• Study Completion Date: 2021-11-12

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Patient with an indication for a COVID19 test

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

Group Type: EXPERIMENTAL

Salivary test for COVID19

Intervention Type: 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

Interventions

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

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 3 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centre Hospitalier de Cayenne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

General Hospital of Cayenne

Cayenne, , French Guiana

Countries

French Guiana

Other Identifiers

COVISAL

Identifier Type: -

Identifier Source: org_study_id