Use of an antiviral mouthwash as a barrier measure in the SARS-CoV-2 transmission in adults with asymptomatic to mild COVID-19: a multicentre, randomized, double-blind controlled trial

Florence Carrouel, Martine Valette, Emilie Gadea, Aurélie Esparcieux, Gabriela Illes, Marie Elodie Langlois, Hervé Perrier, Claude Dussart, Paul Tramini, Mélina Ribaud, Maude Bouscambert-Duchamp, Denis Bourgeois, Florence Carrouel, Martine Valette, Emilie Gadea, Aurélie Esparcieux, Gabriela Illes, Marie Elodie Langlois, Hervé Perrier, Claude Dussart, Paul Tramini, Mélina Ribaud, Maude Bouscambert-Duchamp, Denis Bourgeois

Abstract

Objectives: To determine if commercially available mouthwash with β-cyclodextrin and citrox (bioflavonoids) (CDCM) could decrease the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) salivary viral load.

Methods: In this randomized controlled trial, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) PCR-positive patients aged 18-85 years with asymptomatic to mild coronavirus disease 2019 (COVID-19) symptoms for <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 09.00 (T1), 13.00 (T2) and 18.00 (T3). On the following 6 days, one sample was taken at 15.00. Quantitative RT-PCR was used to detect SARS-CoV-2.

Results: The intention-to-treat analysis demonstrated that, over the course of 1 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% (IQR -29.55% to -0.16%). The second dose maintained the low median value for the CDCM (3.08 log10 copies/mL; IQR 0-4.19), compared with placebo (3.31 log10 copies/mL; IQR 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%; IQR -100% to -34.36%) compared with the placebo group (-50.62%; IQR -100% to -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 with placebo in reducing viral load in saliva.

Keywords: Citrox; Coronavirus disease 2019; Mouthwash; Saliva; Severe acute respiratory syndrome coronavirus 2; Viral load; β-cyclodextrin.

Copyright © 2021 The Author(s). Published by Elsevier Ltd.. All rights reserved.

Figures

Fig. 1
Fig. 1
BBCovid trial profile.
Fig. 2
Fig. 2
Evolution of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) salivary load within the mouthwash cohorts at day 1 (intention-to-treat analysis). (a) Evolution for all patients. (b) SARS-CoV-2 viral load difference between T1 and T2 for all patients. (c) Evolution for patients with a SARS-CoV-2 viral load >2.94 log10 copies/mL at day 1 T1. (d) SARS-CoV-2 viral load difference between T1 and T2 for patients with a SARS-CoV-2 viral load >2.94 log10 copies/mL at day 1 T1. (e) Evolution for patients with a SARS-CoV-2 viral load >4.01 log10 copies/mL at day 1 T1. (f) SARS-CoV-2 viral load difference between T1 and T2 for patients with a SARS-CoV-2 viral load >4.01 log10 copies/mL at day 1 T1. (g) Evolution for patients with a SARS-CoV-2 viral load >5.03 log10 copies/mL at day 1 T1. (h) SARS-CoV-2 viral load difference between T1 and T2 for patients with a SARS-CoV-2 viral load >5.03 log10 copies/mL at day 1 T1.
Fig. 3
Fig. 3
Evolution of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) salivary load within the mouthwash cohorts from day 1 to day 7 (intention-to-treat analysis). (a) Evolution for all patients. (b) Evolution for patients with a SARS-CoV-2 viral load >2.94 log10 copies/mL at day 1 T1. (c) Evolution for patients with a SARS-CoV-2 viral load >4.01 log10 copies/mL at day 1 T1. (d) Evolution for patients with a SARS-CoV-2 viral load >5.03 log10 copies/mL at day 1 T1.

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