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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04352959
Other study ID # BBCovid
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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