Using a mouthwash containing β-cyclodextrin and citrox (bioflavonoids) (CDCM), available in pharmacies, helps reduce the SARS-CoV-2 viral load in saliva
Keywords: Citrox; COVID-19; Mouthwash; Saliva; SARS-CoV-2; Viralload; ß-cyclodextrin
The intention-to-treat analysis demonstrated that, over the course of one day, CDCM was significantly more effective than placebo 4 hours after the first dose (p=0.036), with a median percentage (log10 copies/mL) decrease T1-T2 of -12.58% [-29.55% – -0.16%].
The second dose maintained the low median value for the CDCM (3.08 log10 copies/mL [0 – 4.19]), compared to placebo (3.31 [1.18 – 4.75]).
At day 7, there was still a greater median percentage (log10 copies/mL) decrease in salivary viral load over time in the CDCM group (-58.62% [-100% – -34.36%]) compared to placebo group (-50.62% [-100% – -27.66%]). These results were confirmed by the per-protocol analysis.
Description of the Study:
- Title: Use of an antiviral mouthwash as a barrier measure in the SARS-Cov-2 transmission in adults with asymptomatic to mild COVID-19: a multicenter, randomized, double-blind controlled trial
- Principal Investigators: Florence Carrouel, Martine Valette, Emilie Gadea, Aurélie Esparcieux, Gabriela Illes, Marie Elodie Langlois, Hervé Perrier, Claude Dussart, Paul Tramini, Mélina Ribaud, Maude Bouscambert-Duchamp and Denis Bourgeois.
- Centers of Implementation: Participants were enrolled at four French hospital centers, and monitoring occurred at home.
- Study Population: SARS-CoV-2 PCR-positive patients aged 18-85 years with 36 asymptomatic to mild COVID-19 symptoms <8 days were recruited.
- Study Type: A multicenter, randomized, double-blind controlled trial.
- Methods: A total of 176 eligible 37 patients were randomly assigned (1:1) to CDCM or placebo. Three rinses daily were performed for 7 days. Saliva sampling was performed on day 1 at 9 a.m. (T1), 1 p.m. (T2) and 6 p.m. (T3). On the following 6 days, one sample was taken at 3 p.m. Quantitative RT-PCR 40 was used to detect SARS-CoV-2.
Objectives of the Study:
Principal Objective: To determine if commercially available mouthwash with ß-cyclodextrin and citrox (bioflavonoids) (CDCM) could decrease the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) salivary viral load.
More about this Study:
SARS-CoV-2 may be transmitted via saliva, even in patients who do not cough or have other respiratory symptoms. SARS-CoV-2 is identified in 91.7% of saliva samples from COVID-19 patients, and the load can reach up to 1.2×108 copies/mL.
The use of mouthwashes is an “adjuvant” treatment part of the usual treatment or individual prophylaxis, especially in oral health. Considering mouthwashes as agents that can decrease the viral load of SARS-CoV-2 is an extremely attractive concept. However, there is no in vivo evidence to recommend mouthwashes to control SARS-CoV-2 viral load. Among antiviral molecules contained in mouthwashes, hydrogen peroxide, ß-cyclodextrin, flavonoids, essential oils, cetylpyridinium chloride or povidone-iodine could be of interest in the fight against SARS-CoV-2. The antiviral activity of CDCM in our trial is based on ß-cyclodextrin and citrox (flavonoids). These molecules have demonstrated antiviral activity against several viruses, but evidence for their action against SARS-CoV-2 was based only on in silico studies.
Other Clinical Trials:
Clinical trial designed to evaluate the safety and immunogenicity of a dose of Comirnaty vaccine (Pfizer) in people who have previously received a dose of Vaxcevria vaccine (AstraZeneca).
This study aims to demonstrate efficacy of Montelukast for patients with persistent COVID-19 to help them improve their quality of life.
Early administration of convalescent plasma in people over 50 years of age with mild to moderate COVID-19 disease may slow disease progression and decrease the severity of symptoms.
This pediatric clinical trial aims to test the safety, tolerability and immunogenicity of Pfizer’s COVID vaccine in children under 12 years of age.
The LacCOVID study has shown that milk from lactating women who have been vaccinated with Pfizer-BioNTech contains specific antibodies against the SARS-CoV-2 coronavirus.
Clinical trial to perform immunomodulatory treatment in adult patients with severe COVID-19 pneumonia with the aim of helping to define the standard treatment for this disease.
This multicentre clinical trial aims to demonstrate that treatment with Calcifediol reduces the need for invasive ventilation and Intensive Care Unit admissions and deaths.
Phase II clinical trial evaluating the safety and efficacy of the drug Maraviroc combined with standard therapy versus standard therapy in patients infected with SARS-CoV-2 and hospitalised with COVID-19.