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

COVID19 Clinical Trial

— BBCovid  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04352959
• Other study ID #: BBCovid
• Status: Completed
• Phase: N/A
• Start date: April 27, 2020
• Est. completion date: December 11, 2020

Study information

• Verified date: February 2021
• Source: Claude Bernard University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 176
• Est. completion date: December 11, 2020
• Est. primary completion date: December 11, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID19
• Mouthwash
• Saliva

Intervention

Device:
• mouthrinse with bêta-cyclodextrin and citrox
3 daily mouthrinses for 7 days
• mouthrinse without bêta-cyclodextrin and citrox
3 daily mouthrinses for 7 days

Locations

Country	Name	City	State
France	Clinic of the Protestant Infirmary in Lyon	Caluire-et-Cuire
France	Hospital Center Emile Roux	Le Puy en Velay
France	Hospital Center Saint Luc Saint Joseph	Lyon
France	Intercommunal Hospital Center of Mont de Marsan	Mont de Marsan

Sponsors (2)

Lead Sponsor	Collaborator
Claude Bernard University	Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

References & Publications (2)

Carrouel F, Conte MP, Fisher J, Gonçalves LS, Dussart C, Llodra JC, Bourgeois D. COVID-19: A Recommendation to Examine the Effect of Mouthrinses with ß-Cyclodextrin Combined with Citrox in Preventing Infection and Progression. J Clin Med. 2020 Apr 15;9(4). pii: E1126. doi: 10.3390/jcm9041126. — View Citation

Carrouel F, Gonçalves LS, Conte MP, Campus G, Fisher J, Fraticelli L, Gadea-Deschamps E, Ottolenghi L, Bourgeois D. Antiviral Activity of Reagents in Mouth Rinses against SARS-CoV-2. J Dent Res. 2021 Feb;100(2):124-132. doi: 10.1177/0022034520967933. Epub 2020 Oct 22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline amount of SARS-CoV-2 in salivary samples at 7 days	Quantitative PCR experiments will be performed and a quantitative analysis of the salivary samples will be made	7 days
Secondary	Change from Baseline amount of SARS-CoV-2 virus in nasal samples at 7 days	Quantitative PCR experiments will be performed and a quantitative analysis of the nasal samples will be made	7 days