Study of the Analytical Performance of Different Salivary Self-collection Methods for the Detection of COVID-19

SARS-CoV Infection Clinical Trial

— SAMILCOV  

Official title:

Study of the Analytical Performance of Different Salivary Self-collection Methods for the Detection of COVID-19.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04550390
• Other study ID #: 2020-COVID19-36
• Secondary ID: 2020-A02536-33
• Status: Completed
• Start date: September 15, 2020
• Est. completion date: October 19, 2020

Study information

• Verified date: March 2021
• Source: Direction Centrale du Service de Santé des Armées
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Since March 2020, the SARS-CoV type coronavirus infection (SARS-CoV-2; nCoV19; COVID-19) is considered pandemic. As early as April 2020, the World Health Organization recommended the implementation of mass screening of populations, with the aim of identifying cases and contacts and controlling viral spread. Since the end of lock-down on May 11, 2020,the screening policy has been intensified to fight against COVID-19. Virological tests by RT-PCR are thus accessible to all, without a prescription and reimbursed by health insurance. The French government has also set a quantitative target of 1 million tests per week. In order to meet this target, the number of sampling centers has been increased (mobile structures, etc.).

Screening tests are currently carried out using a nasopharyngeal swab analyzed by RT-PCR for the detection of viral RNA. This type of sample has several technical and logistic constraints. It must be carried out by personnel who are authorized and trained in this procedure and in appropriate hospital hygiene practices. It exposes the sampling personnel to possible contamination through nasopharyngeal secretions or coughing that may occur during sampling. With the increase in screening, there are sometimes insufficient numbers of sampling personnel and there is significant market pressure for swabs and virological transport media.

In addition, these swabs are uncomfortable or even painful for the patient, which could imply a reluctance to be screened. They are also complicated in children, whether they are rhino- or oropharyngeal.

An alternative to the nasopharyngeal swab, which is the subject of this project, would be to have one or more reliable sampling methods that are less restrictive than the nasopharyngeal swab ("gold standard"). Thus, we propose to test and compare the results obtained by molecular biology techniques on nasopharyngeal, salivary and buccal swabs.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 329
• Est. completion date: October 19, 2020
• Est. primary completion date: October 19, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• To be at least 18 years of age

• To come at hospital for SARS-CoV-2 screening

• To be able to receive a nasopharyngeal swab

Exclusion Criteria:

• People under 18 years of age

• Inpatient in intensive care

• Pregnant or breastfeeding woman

• Individual with dry syndrome (Gougerot-Sjögren syndrome)

• Taking treatments that reduce salivary volume (anticholinergic activity)

• People with a COVID-19 diagnosis confirmed by a molecular biology method >7 days ago

• Contraindication to oral swabbing

Related Conditions & MeSH terms

• Coronavirus Infections
• SARS-CoV Infection
• Severe Acute Respiratory Syndrome

Intervention

Diagnostic Test:
• Saliva collection
2 saliva samples are self-collected by participants

Locations

Country	Name	City	State
France	Hôpital d'Instruction des Armées Percy	Clamart
France	Hôpital d'Instruction des Armées Laveran	Marseille
France	Hôpital d'Instruction des Armées Bégin	Saint-Mandé
France	Hôpital d'Instruction des Armées Sainte-Anne	Toulon

Sponsors (1)

Lead Sponsor	Collaborator
Direction Centrale du Service de Santé des Armées

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Qualitative result of molecular tests for the SARS-CoV-2 virus.	Qualitative result may be : "positive", "negative" or "invalid". The test results will be compared between the two types of collection method.	At enrollment (day 1)