Background The research hypothesis is that commercially available mouthwash with ß-cyclodextrin and citrox (bioflavonoids) could decrease the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) salivary viral load in adults with asymptomatic to mild COVID-19. 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 154 eligible patients were randomly assigned (1:1) to antiviral ß-cyclodextrin and citrox mouthwash (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. The trial is registered at ClinicalTrials.gov (NCT04349592). Findings CDCM was significantly more effective than placebo 4 hours after the first intake (p<0·001), with a median percentage decrease T1-T2 of -14·25% [95% CI; -32·68% - 0·06%]. In patients with an initial salivary load > 2·95 log10 copies/mL, there was a significant difference in the reduction in viral load at T2. Over the course of one day, the first mouthwash rinse significantly reduced the viral load, and the second dose maintained this low value, compared to placebo. At day 7, there was still a greater decrease in salivary viral load over time in the CDCM group. In individuals with an initial viral SARS-CoV-2 load higher than 4·12 log10 copies/mL or 5·16 log10 copies/mL, CDCM reduced the salivary viral load more quickly than placebo (MLM p-value = 0·03; 0·029). Interpretation This trial supports the relevance of using mouthwash with ß-cyclodextrin and citrox as an additional barrier measure on day 1 to reduce the dissemination of SARS-CoV-2. Over 7 days, the use of this mouthwash showed a benefit of viral load reduction for patients with the highest initial loads.
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