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
Clinical Microbiology and Infection, doi:10.1016/j.cmi.2021.05.028
Objectives: To determine if commercially available mouthwash with b-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 18e85 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 (log 10 copies/mL) decrease T1eT2 of e12.58% (IQR e29.55% to e0.16%). The second dose maintained the low median value for the CDCM (3.08 log 10 copies/mL; IQR 0e4.19), compared with placebo (3.31 log 10 copies/mL; IQR 1.18e4.75). At day 7, there was still a greater median percentage (log 10 copies/mL) decrease in salivary viral load over time in the CDCM group (e58.62%; IQR e100% to e34.36%) compared with the placebo group (e50.62%; IQR e100% to e27.66%). 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.
Authors contributions FC, DB and CD proposed the original study idea. FC was the coordinating officer of this trial. FC, PT, CD and DB designed the trial and study protocol. MV, PT, MR and FC contributed to the data interpretation and PT, FC, MV and HP verified the data. EGD, AE, MEL and GI were responsible for the site work including the recruitment, follow up and data collection. HP monitored the trial. MBD and MV were responsible for the laboratory analysis. PT and MR did the main analysis. FC and DB wrote the first draft the manuscript and CD, MBD, MR, MV and PT contributed to the revision of the manuscript. All authors reviewed and accepted the paper before submission.
Access to data Florence Carrouel has full access to the data and is the guarantor for the data.
Appendix A. Supplementary data Supplementary data to this article can be found online at https://doi.org/10.1016/j.cmi.2021.05.028 .
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