COVID19 Clinical Trial
— BBCovidOfficial title:
COVID-19: Nasal and Salivary Detection of the SARS-CoV-2 Virus After Antiviral Mouthrinses: Double-blind, Randomized, Placebo-controlled Clinical Study
Verified date | February 2021 |
Source | Claude Bernard University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Claude Bernard University | Hospices Civils de Lyon |
France,
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
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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