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 (log 10 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 log 10 copies/mL; IQR 0-4.19), compared with placebo (3.31 log 10 copies/mL; IQR 1.18-4.75). 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 (-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.
【저자키워드】 severe acute respiratory syndrome coronavirus 2, Saliva, Coronavirus disease 2019, Viral load, Mouthwash, Citrox, β-cyclodextrin., 【초록키워드】 COVID-19, Randomized controlled trial, coronavirus disease, severe acute respiratory syndrome coronavirus 2, SARS-CoV-2, Saliva, Coronavirus disease 2019, coronavirus, Trial, Symptom, severe acute respiratory syndrome Coronavirus, Viral load, Placebo, Mouthwash, disease, dose, cyclodextrin, Support, acute respiratory syndrome, acute respiratory syndrome coronavirus, acute respiratory syndrome coronavirus 2, Quantitative RT-PCR, placebo group, second dose, first dose, SARS-CoV-2 viral load, intention-to-treat analysis, treat, median value, per-protocol analysis, salivary, effective, benefit, decrease, Randomly, initial, Course, log, greater, performed, was used, detect, significantly more, recruited, was performed, median, appear, determine, reducing, demonstrated, reduce, assigned, 1:1, asymptomatic to mild, eligible patient, IQR, PCR-positive patient, the placebo group, the SARS-CoV-2, 【제목키워드】 Transmission, Randomized, Controlled trial, multicentre, double-blind, antiviral mouthwash, asymptomatic to mild, the SARS-CoV-2,