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Cetylpyridinium Chloride Mouthwash to Reduce Shedding of Infectious SARS-CoV-2: A Double-Blind Randomized Clinical Trial

Alemany et al., Journal of Dental Research, doi:10.1177/00220345221102310, NCT04757818
Jun 2022  
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118 patient RCT testing cetylpyridinium chloride (CPC) mouthwash, showing significantly increased detection of SARS-CoV-2 nucleocapsid protein, indicating viral lysis. CPC inactivates SARS-CoV-2 by degrading its membrane, exposing the nucleocapsid of the virus. Notably, there was no significant difference in viral load detected with PCR, highlighting the limitations of PCR, which is unable to differentiate between intact infectious virus and non-infectious or destroyed virus particles. PCR viral load may not correlate well with actual remaining infectivity after treatments like mouthwashes.
Alemany et al., 21 Jun 2022, Double Blind Randomized Controlled Trial, placebo-controlled, Spain, peer-reviewed, 31 authors, study period 15 February, 2021 - 2 June, 2021, trial NCT04757818 (history).
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Cetylpyridinium Chloride Mouthwash to Reduce Shedding of Infectious SARS-CoV-2: A Double-Blind Randomized Clinical Trial
A Alemany, D Perez-Zsolt, D Raïch-Regué, J Muñoz-Basagoiti, D Ouchi, C Laporte-Villar, B Baro, N Henríquez, N Prat, M Ochoa Gianinetto, M Viaplana Gutiérrez, M Garcia Sánchez-Paniagua, N Larrosa Henríquez, J Moreno Vicente, J Ara, M A Rodriguez-Arias, J Puig, I Blanco, C Casañ Lopez, Á Hernández, A E Bordoy, C Esteban Redondo, V González Soler, M Giménez, V Blanc, R León, J Gispert, B Clotet, N Izquierdo-Useros, O Mitjà
Journal of Dental Research, doi:10.1177/00220345221102310
The airborne transmission of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) via respiratory fluids and droplets suggests that mouthwashes containing substances with virucidal activity can help reduce viral spread. We conducted a multicenter, double-blind, placebo-controlled, randomized trial to assess the virucidal activity of cetylpyridinium chloride (CPC) mouthwashes. Outpatients who tested positive for SARS-CoV-2 infection with or without symptoms were randomized to perform washes and gargles for 1 min with 15 mL of either colored distilled water or 0.07% CPC (Vitis CPC Protect) mouthwash. The study outcomes were the SARS-CoV-2 log 10 viral RNA load and the nucleocapsid protein levels, both in saliva at 1 and 3 h after the intervention. In total, 118 patients were enrolled and randomized (mean [SD], age 46 [14] y). Thirteen of 118 participants (11%) did not complete follow-up or had insufficient sample volume for testing and were excluded from the analysis. The assessment of the viral load showed no significant differences between groups at any of the investigated points. However, the levels of SARS-CoV-2 nucleocapsid protein of lysed viruses were significantly higher in the CPC group compared with the control group at 1 h (adjusted difference 269.3 pg/mL; 95% confidence interval [CI], 97.1-441.5) and at 3 h postintervention (561.1 pg/mL; 95% CI, 380.0-742.2). In nonhospitalized patients with asymptomatic or mild symptomatic SARS-CoV-2 infection, a 0.07% CPC mouthwash, compared to placebo, was associated with a significant increase of nucleocapsid protein levels in saliva, indicating enhanced disruption of viral particles.
Author Contributions A. Alemany, contributed to conception, design, data acquisition, analysis, and interpretation, drafted and critically revised the manuscript; D. Perez-Zsolt, D. Raïch-Regué, J. Muñoz-Basagoiti, D. Ouchi, J. Ara, M.A. Rodriguez-Arias, J. Puig, I. Blanco, C. Casañ Lopez, A. Hernández, A.E. Bordoy, C. Esteban Redondo, V. González Soler, M. Giménez, contributed to data analysis and interpretation, critically revised the manuscript; C. Laporte-Villar, M. Ochoa Gianinetto, M. Viaplana Gutiérrez, M. Garcia Sánchez-Paniagua, N. Larrosa Henríquez, J. Moreno Vicente, contributed to data acquisition, critically revised the manuscript; B. Baro, contributed to conception, design, data analysis, and interpretation, critically revised the manuscript; N. Henríquez, N. Prat, contributed to data acquisition, analysis, and interpretation, critically revised the manuscript; V. Blanc, R. León, J. Gispert, contributed to conception and design, critically revised the manuscript; B. Clotet, N. Izquierdo-Useros, contributed to conception, design, data acquisition, analysis, and interpretation, critically revised the manuscript; O. Mitjà, contributed to conception, design, data acquisition, analysis, and interpretation, drafted and critically revised the manuscript. All authors gave final approval and agree to be accountable for all aspects of the work. Declaration of Conflicting Interests The authors declared the following potential conflicts of interest with respect to the..
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