Florence Carrouel1, Martine Valette2, Emilie Gadea3, Aurélie Esparcieux4, Gabriela Illes5, Marie Elodie Langlois6, Hervé Perrier7, Claude Dussart8, Paul Tramini9, Mélina Ribaud10, Maude Bouscambert-Duchamp2, Denis Bourgeois8. 1. Laboratory "Systemic Health Care", EA4129, University of Lyon, University Claude Bernard Lyon 1, Lyon, France. Electronic address: florence.carrouel@univ-lyon1.fr. 2. Virology Laboratory, Institute of Infectious Agents, National Center for Virus of Respiratory Infections, Croix-Rousse Hospital, Hospices Civils of Lyon, Lyon, France. 3. Equipe SNA-EPIS, EA4607, University Jean Monnet, Saint-Etienne, France; Clinical Research Unit, Emile Roux Hospital Center, le Puy-en-Velay, France. 4. Department of Internal Medicine and Infectious Diseases, Protestant Infirmary, Caluire-et-Cuire, France. 5. Department of Internal Medicine and Infectious Diseases, Intercommunal Hospital Center of "Mont de Marsan et du Pays des Sources », Mont de Marsan, France. 6. Department of Internal Medecine and Infectious Diseases, Saint Joseph Saint Luc Hospital, Lyon, France. 7. Clinical Research Unit, Protestant Infirmary, Lyon, France. 8. Laboratory "Systemic Health Care", EA4129, University of Lyon, University Claude Bernard Lyon 1, Lyon, France. 9. Department of Public Health, Faculty of Dental Medicine, University of Montpellier, Montpellier, France. 10. National Institute of Agronomic Research (INRAE), BioSP, UR546, Avignon, France.
Abstract
OBJECTIVES: 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. METHODS: In this RCT, SARS-CoV-2 PCR-positivepatients aged 18-85 years with asymptomatic to mild COVID-19 symptoms <8 days were recruited. A total of 176 eligible 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 was used to detect SARS-CoV-2. RESULTS: 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. CONCLUSIONS: This trial supports the relevance of using CDCM on day 1 (4 hours after the initial dose) to reduce the SARS-CoV-2 viral load in saliva. For long term effect (7 days), CDMC appears to provide a modest benefit compared to placebo in reducing viral load in saliva.
RCT Entities:
OBJECTIVES: 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. METHODS: In this RCT, SARS-CoV-2 PCR-positive patients aged 18-85 years with asymptomatic to mild COVID-19 symptoms <8 days were recruited. A total of 176 eligible 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 was used to detect SARS-CoV-2. RESULTS: 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. CONCLUSIONS: This trial supports the relevance of using CDCM on day 1 (4 hours after the initial dose) to reduce the SARS-CoV-2 viral load in saliva. For long term effect (7 days), CDMC appears to provide a modest benefit compared to placebo in reducing viral load in saliva.
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