A MULTICENTER, RANDOMIZED, OPEN-LABEL, PLACEBO-CONTROLLED CLINICAL TRIAL OF THE EFFECT OF CETYLPYRIDINIUM CHLORIDE (CPC) MOUTHWASH AND ON-DEMAND AQUEOUS CHLORINE DIOXIDE MOUTHWASH ON SARS-COV-2 VIRAL TITER IN PATIENTS WITH MILD COVID-19.

OBJECTIVES

The established effect of cetylpyridinium chloride (CPC) mouthwash on SARS-CoV-2 viral titers is unclear. No clinical trial has examined the impact of on-demand aqueous chlorine dioxide mouthwash on SARS-CoV-2 viral titer.

METHODS

In this multicenter, 3-armed, randomized, open-label, placebo-controlled clinical trial involving mildly symptomatic COVID-19 patients, we randomly assigned them to receive 20 mL of 0.05% CPC, 10 mL of 0.01% on-demand aqueous chlorine dioxide, or 20 mL of purified water as a placebo mouthwash in a 1:1:1 ratio. The primary measurement was the SARS-CoV-2 viral titer in saliva, evaluated by a mixed-effects linear regression model.

RESULTS

49 patients received CPC mouthwash (n=16), on-demand aqueous chlorine dioxide mouthwash (n=16), and placebo (n=17) between January 14, 2024, and February 20, 2024. 0.05% CPC mouthwash significantly reduced salivary viral titer at 10 minutes postuse (-0.97 log PFU/mL; 95% CI, -1.64 to -0.30; P = .004), while no such effect was observed at 30 minutes (difference vs placebo, -0.26 log PFU/mL; 95% CI, -0.92 to 0.40; P = .435) or 60 minutes (difference vs. placebo, -0.05 log PFU/mL; 95% CI, -0.68 to 0.58; P = .877). 0.01% on-demand chlorine dioxide mouthwash did not reduce salivary viral titer at 10 minutes, 30 minutes, or 60 minutes compared to placebo.

CONCLUSIONS

10 minutes after using a 0.05% CPC mouthwash, the salivary viral titer of SARS-CoV-2 decreased compared to placebo. 0.01% on-demand aqueous chlorine dioxide mouthwash and placebo had no significant difference in SARS-CoV-2 viral titers.

TRIAL REGISTRATION

Japan Registry of Clinical Trials (jRCT): jRCTs031230566.