BBCovid: COVID-19: Nasal and Salivary Detection of the SARS-CoV-2 Virus After Antiviral Mouthrinses

Sponsor

Claude Bernard University (Other)

Overall Status

Completed

CT.gov ID

NCT04352959

Collaborator

Hospices Civils de Lyon (Other)

176

Enrollment

Locations

Arms

7.5

Actual Duration (Months)

Patients Per Site

5.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Given the current lack of effective COVID-19 treatment, it is necessary to explore alternative methods to contain the spread of the infection, focusing in particular on its mode of transmission. The modes of person-to-person transmission of SARS-CoV-2 are direct transmission, such as sneezing, coughing, transmission through inhalation of small droplets, and transmission through contact, such as contact with nasal, oral and eye mucous membranes. SARS-CoV-2 can also be transmitted directly or indirectly through saliva. The use of antiviral mouthrinses may be used as adjunctive therapy.

Condition or Disease	Intervention/Treatment	Phase
COVID19 Mouthwash Saliva	Device: mouthrinse with bêta-cyclodextrin and citrox Device: mouthrinse without bêta-cyclodextrin and citrox	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

176 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Prevention

Official Title:

COVID-19: Nasal and Salivary Detection of the SARS-CoV-2 Virus After Antiviral Mouthrinses: Double-blind, Randomized, Placebo-controlled Clinical Study

Actual Study Start Date :

Apr 27, 2020

Actual Primary Completion Date :

Dec 11, 2020

Actual Study Completion Date :

Dec 11, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: mouth rinse with antiviral	Device: mouthrinse with bêta-cyclodextrin and citrox 3 daily mouthrinses for 7 days
Placebo Comparator: mouth rinse without antiviral	Device: mouthrinse without bêta-cyclodextrin and citrox 3 daily mouthrinses for 7 days

Arm

Intervention/Treatment

Active Comparator: mouth rinse with antiviral

Device: mouthrinse with bêta-cyclodextrin and citrox

3 daily mouthrinses for 7 days

Placebo Comparator: mouth rinse without antiviral

Device: mouthrinse without bêta-cyclodextrin and citrox

3 daily mouthrinses for 7 days

Outcome Measures

Primary Outcome Measures

Change from Baseline amount of SARS-CoV-2 in salivary samples at 7 days [7 days]
Quantitative PCR experiments will be performed and a quantitative analysis of the salivary samples will be made

Secondary Outcome Measures

Change from Baseline amount of SARS-CoV-2 virus in nasal samples at 7 days [7 days]
Quantitative PCR experiments will be performed and a quantitative analysis of the nasal samples will be made

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Clinical diagnosis of Covid-19 infection by the patient's general practitioner and hospital doctor
Clinical signs started less than 8 days ago.
Virological confirmation
Understanding and acceptance of the trial.
Written agreement to participate in the trial

Exclusion Criteria:

Pregnancy
Breastfeeding
Inability to comply with protocol
Lack of written agreement

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Clinic of the Protestant Infirmary in Lyon	Caluire-et-Cuire	France	69300
2	Hospital Center Emile Roux	Le Puy en Velay	France	43000
3	Hospital Center Saint Luc Saint Joseph	Lyon	France	69007
4	Intercommunal Hospital Center of Mont de Marsan	Mont de Marsan	France	40000