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Oral mouthwashes for asymptomatic to mildly symptomatic adults with COVID-19 and salivary viral load: a randomized, placebo-controlled, open-label clinical trial

Onozuka et al., BMC Oral Health, doi:10.1186/s12903-024-04246-1, jRCTs051220107
Apr 2024  
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RCT 90 low-risk asymptomatic to mildly symptomatic COVID-19 patients showing no significant difference in salivary viral load with cetylpyridinium chloride or on-demand aqueous chlorine dioxide mouthwash. Both treatments increased Ct values at all time intervals more than placebo, but without statistical significance.
The baseline Ct values are very high, especially in the placebo (38.0) and CPC (38.6) groups, indicating low viral loads and limited room for improvement in short-term Ct values. Treatment may minimize progression, however authors only follow patients for one day. Authors report only relative changes, therefore it is unknown if viral load increased or decreased in each arm.
Analysis of short-term changes in viral load using PCR may not detect effective treatments because PCR is unable to differentiate between intact infectious virus and non-infectious or destroyed virus particles. For example Alemany, Tarragó‐Gil perform RCTs with cetylpyridinium chloride (CPC) mouthwash that show no difference in PCR viral load, however there was 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. To better estimate changes in viral load and infectivity, methods like viral culture that can differentiate intact vs. degraded virus are preferred.
This study is excluded in meta analysis: study only provides short-term viral load results.
Onozuka et al., 25 Apr 2024, Randomized Controlled Trial, placebo-controlled, Japan, peer-reviewed, 10 authors, study period 7 November, 2022 - 19 January, 2023, trial jRCTs051220107. Contact: onozukad@hp-infect.med.osaka-u.ac.jp, kutsuna@hp-infect.med.osaka-u.ac.jp.
This PaperCetylpyridin..All
Oral mouthwashes for asymptomatic to mildly symptomatic adults with COVID-19 and salivary viral load: a randomized, placebo-controlled, open-label clinical trial
Daisuke Onozuka, Satoko Takatera, Hiroo Matsuo, Hisao Yoshida, Shigeto Hamaguchi, Shungo Yamamoto, Ryuichi Minoda Sada, Koichiro Suzuki, Keiji Konishi, Satoshi Kutsuna
BMC Oral Health, doi:10.1186/s12903-024-04246-1
Background Recent randomized clinical trials suggest that the effect of using cetylpyridinium chloride (CPC) mouthwashes on the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral load in COVID-19 patients has been inconsistent. Additionally, no clinical study has investigated the effectiveness of on-demand aqueous chlorine dioxide mouthwash against COVID-19. Methods We performed a randomized, placebo-controlled, open-label clinical trial to assess for any effects of using mouthwash on the salivary SARS-CoV-2 viral load among asymptomatic to mildly symptomatic adult COVID-19-positive patients. Patients were randomized to receive either 20 mL of 0.05% CPC, 10 mL of 0.01% on-demand aqueous chlorine dioxide, or 20 mL of placebo mouthwash (purified water) in a 1:1:1 ratio. The primary endpoint was the cycle threshold (Ct) values employed for SARS-CoV-2 salivary viral load estimation. We used linear mixed-effects models to assess for any effect of the mouthwashes on SARS-CoV-2 salivary viral load. Results Of a total of 96 eligible participants enrolled from November 7, 2022, to January 19, 2023, 90 were accepted for the primary analysis. The use of 0.05% CPC mouthwash was not shown to be superior to placebo in change from baseline salivary Ct value at 30 min (difference vs. placebo, 0.640; 95% confidence interval [CI], -1.425 to 2.706; P = 0.543); 2 h (difference vs. placebo, 1.158; 95% CI, -0.797 to 3.112; P = 0.246); 4 h (difference vs. placebo, 1.283; 95% CI, -0.719 to 3.285; P = 0.209); 10 h (difference vs. placebo, 0.304; 95% CI, -1.777 to 2.385; P = 0.775); or 24 h (difference vs. placebo, 0.782; 95% CI, -1.195 to 2.759; P = 0.438). The use of 0.01% on-demand aqueous chlorine dioxide mouthwash was also not shown to be superior to placebo in change from baseline salivary Ct value at 30 min (difference vs. placebo, 0.905; 95% CI, -1.079 to 2.888; P = 0.371); 2 h (difference vs. placebo, 0.709; 95% CI, -1.275 to 2.693; P = 0.483); 4 h (difference vs. placebo, 0.220; 95% CI, -1.787 to 2.226; P = 0.830); 10 h (difference vs. placebo, 0.198; 95% CI, -1.901 to 2.296; P = 0.854); or 24 h (difference vs. placebo, 0.784; 95% CI, -1.236 to 2.804; P = 0.447).
Supplementary Information The online version contains supplementary material available at https://doi. org/10.1186/s12903-024-04246-1. Supplementary Material 1 Author contributions S.K supervised the project. D.O., S.T., and S.K. made substantial contributions to conception and design. D.O., S.T., H.M., H.Y., S.H., S.Y., R.M.S., and K.K. collected data. K.S. conducted laboratory test. D.O. analyzed the data, wrote the first draft of the manuscript, and interpreted the results. D.O., S.T., H.M., H.Y., S.H., S.Y., R.M.S., K.S., K.K., and S.K. contributed to critical revision of the manuscript. All authors were involved in data interpretation and made meaningful contributions to the final submitted manuscript. Data availability The datasets used and analyzed during the current study are available from the corresponding author on reasonable request. Declarations Ethics approval and consent to participate This open-label, randomized, placebo-controlled clinical trial was approved by the Ethical Committee of Osaka University (No. S22003) on 6/10/2022, and was registered with the Japan Registry of Clinical Trials (jRCT) (No. jRCTs051220107) on 18/10/2022. This trial was conducted in compliance with the provisions of the Declaration of Helsinki, Good Clinical Practice Guidelines, and local regulatory requirements. Patient registration was conducted from 7/11/2022 to 19/1/2023 in Osaka, Japan, and all of the participants provided written informed consent. Consent for..
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{ 'DOI': '10.1186/s12903-024-04246-1', 'ISSN': ['1472-6831'], 'URL': 'http://dx.doi.org/10.1186/s12903-024-04246-1', 'abstract': '<jats:title>Abstract</jats:title><jats:sec>\n' ' <jats:title>Background</jats:title>\n' ' <jats:p>Recent randomized clinical trials suggest that the effect of using ' 'cetylpyridinium chloride (CPC) mouthwashes on the severe acute respiratory syndrome ' 'coronavirus 2 (SARS-CoV-2) viral load in COVID-19 patients has been inconsistent. ' 'Additionally, no clinical study has investigated the effectiveness of on-demand aqueous ' 'chlorine dioxide mouthwash against COVID-19.</jats:p>\n' ' </jats:sec><jats:sec>\n' ' <jats:title>Methods</jats:title>\n' ' <jats:p>We performed a randomized, placebo-controlled, open-label clinical ' 'trial to assess for any effects of using mouthwash on the salivary SARS-CoV-2 viral load ' 'among asymptomatic to mildly symptomatic adult COVID-19-positive patients. Patients were ' 'randomized to receive either 20 mL of 0.05% CPC, 10 mL of 0.01% on-demand aqueous chlorine ' 'dioxide, or 20 mL of placebo mouthwash (purified water) in a 1:1:1 ratio. The primary ' 'endpoint was the cycle threshold (Ct) values employed for SARS-CoV-2 salivary viral load ' 'estimation. We used linear mixed-effects models to assess for any effect of the mouthwashes ' 'on SARS-CoV-2 salivary viral load.</jats:p>\n' ' </jats:sec><jats:sec>\n' ' <jats:title>Results</jats:title>\n' ' <jats:p>Of a total of 96 eligible participants enrolled from November 7, ' '2022, to January 19, 2023, 90 were accepted for the primary analysis. The use of 0.05% CPC ' 'mouthwash was not shown to be superior to placebo in change from baseline salivary Ct value ' 'at 30\xa0min (difference vs. placebo, 0.640; 95% confidence interval [CI], -1.425 to 2.706; ' '<jats:italic>P</jats:italic>\u2009=\u20090.543); 2\xa0h (difference vs. placebo, 1.158; 95% ' 'CI, -0.797 to 3.112; <jats:italic>P</jats:italic>\u2009=\u20090.246); 4\xa0h (difference vs. ' 'placebo, 1.283; 95% CI, -0.719 to 3.285; <jats:italic>P</jats:italic>\u2009=\u20090.209); ' '10\xa0h (difference vs. placebo, 0.304; 95% CI, -1.777 to 2.385; ' '<jats:italic>P</jats:italic>\u2009=\u20090.775); or 24\xa0h (difference vs. placebo, 0.782; ' '95% CI, -1.195 to 2.759; <jats:italic>P</jats:italic>\u2009=\u20090.438). The use of 0.01% ' 'on-demand aqueous chlorine dioxide mouthwash was also not shown to be superior to placebo in ' 'change from baseline salivary Ct value at 30\xa0min (difference vs. placebo, 0.905; 95% CI, ' '-1.079 to 2.888; <jats:italic>P</jats:italic>\u2009=\u20090.371); 2\xa0h (difference vs. ' 'placebo, 0.709; 95% CI, -1.275 to 2.693; <jats:italic>P</jats:italic>\u2009=\u20090.483); ' '4\xa0h (difference vs. placebo, 0.220; 95% CI, -1.787 to 2.226; ' '<jats:italic>P</jats:italic>\u2009=\u20090.830); 10\xa0h (difference vs. placebo, 0.198; 95% ' 'CI, -1.901 to 2.296; <jats:italic>P</jats:italic>\u2009=\u20090.854); or 24\xa0h (difference ' 'vs. placebo, 0.784; 95% CI, -1.236 to 2.804; <jats:italic>P</jats:italic>\u2009=\u2009' '0.447).</jats:p>\n' ' </jats:sec><jats:sec>\n' ' <jats:title>Conclusions</jats:title>\n' ' <jats:p>In asymptomatic to mildly symptomatic adults with COVID-19, compared ' 'to placebo, the use of 0.05% CPC and 0.01% on-demand aqueous chlorine dioxide mouthwash did ' 'not lead to a significant reduction in SARS-CoV-2 salivary viral load. Future studies of the ' 'efficacy of CPC and on-demand aqueous chlorine dioxide mouthwash on the viral viability of ' 'SARS-CoV-2 should be conducted using different specimen types and in multiple populations and ' 'settings.</jats:p>\n' ' </jats:sec>', 'alternative-id': ['4246'], 'article-number': '491', 'assertion': [ { 'group': {'label': 'Article History', 'name': 'ArticleHistory'}, 'label': 'Received', 'name': 'received', 'order': 1, 'value': '28 December 2023'}, { 'group': {'label': 'Article History', 'name': 'ArticleHistory'}, 'label': 'Accepted', 'name': 'accepted', 'order': 2, 'value': '10 April 2024'}, { 'group': {'label': 'Article History', 'name': 'ArticleHistory'}, 'label': 'First Online', 'name': 'first_online', 'order': 3, 'value': '25 April 2024'}, {'group': {'label': 'Declarations', 'name': 'EthicsHeading'}, 'name': 'Ethics', 'order': 1}, { 'group': {'label': 'Ethics approval and consent to participate', 'name': 'EthicsHeading'}, 'name': 'Ethics', 'order': 2, 'value': 'This open-label, randomized, placebo-controlled clinical trial was approved by ' 'the Ethical Committee of Osaka University (No. S22003) on 6/10/2022, and was ' 'registered with the Japan Registry of Clinical Trials (jRCT) (No. ' 'jRCTs051220107) on 18/10/2022. 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Please send us corrections, updates, or comments. c19early involves the extraction of 100,000+ datapoints from thousands of papers. Community updates help ensure high accuracy. Treatments and other interventions are complementary. All practical, effective, and safe means should be used based on risk/benefit analysis. No treatment or intervention is 100% available and effective for all current and future variants. We do not provide medical advice. Before taking any medication, consult a qualified physician who can provide personalized advice and details of risks and benefits based on your medical history and situation. FLCCC and WCH provide treatment protocols.
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