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Investigation of the effect of mouthwash on the reduction of salivary SARS-CoV-2 in patients with mild or asymptomatic COVID-19

Effect of mouthwash on the reduction of salivary SARS-CoV-2

95

Of 90 subjects for analysis, 51 (56.7%) were male, median age was 33.1 years (interquartile range: 24.4-46.4), median BMI was 22.4 (interquartile range: 20.3-24.3), 12 (13.3%) had a history of smoking, 19 (21.1%) had underlying diseases, 55 (61.1%) had received 3 or more vaccinations, the median days from onset of symptom were 2 days (Interquartile range: 1-2), median Ct value was 37.1 (interquartile range: 34.2-40.4), and median SpO2 was 98 (interquartile range: 98-99).

A total of 95 patients who gave informed consent underwent randomization; 32 were assigned to the placebo group (purified water), 32 were assigned to the Medicinal Mondamin X-9N group, and 31 were assigned to the A2Care mouthwash group. After excluding those who discontinued the study, 31 in the placebo group, 31 in the Medicinal Mondamin X-9N group, and 28 in the A2Care mouthwash group were included in the analysis.

No adverse events were observed.

[Primary endpoint] Compared to the placebo group, the percent change from baseline in salivary SARS-CoV-2 viral load at 2 h was 1.7% (95% confidence interval [CI]: -4.5 to 7.9) in the Medicinal Mondamin X-9N group and 2.6% (95% CI: -3.7 to 8.9) in the A2Care mouthwash group, and there were no significant differences between interventions. [Secondary endpoint] Compared to the placebo group, the percent change from baseline in salivary SARS-CoV-2 viral load at 30 min was 2.8% (95% CI: -4.6 to 10.2) in the Medicinal Mondamin X-9N group and 1.8% (95% CI: -5.0 to 8.7) in the A2Care mouthwash group, and there were no significant differences between interventions. Compared to the placebo group, the percent change from baseline in salivary SARS-CoV-2 viral load at 4 h was was 4.1% (95% CI: -2.9 to 11.2) in the Medicinal Mondamin X-9N group and 1.8% (95% CI: -5.1 to 8.8) in the A2Care mouthwash group, and there were no significant differences between interventions. Compared to the placebo group, the percent change from baseline in salivary SARS-CoV-2 viral load at 10 h was 0.3% (95% CI: -5.7 to 6.4) in the Medicinal Mondamin X-9N group and 0.2% (95% CI: -5.9 to 6.2) in the A2Care mouthwash group, and there were no significant differences between interventions. Compared to the placebo group, the percent change from baseline in salivary SARS-CoV-2 viral load at 24 h was 2.7% (95% CI: -3.5 to 8.9) in the Medicinal Mondamin X-9N group and 3.5% (95% CI: -2.9 to 9.8) in the A2Care mouthwash group, and there were no significant differences between interventions. Compared to the placebo group, the percent change from baseline in SpO2 at 24 h was -0.0% (95% CI: -0.3 to 0.3) in the Medicinal Mondamin X-9N group and -0.1% (95% CI: -0.5 to 0.2) in the A2Care mouthwash group, and there were no significant differences between interventions. Compared to the placebo group, the percent change from baseline in SpO2 in the morning at Day 7 or final day of recuperation was -0.1% (95% CI: -0.5 to 0.3) in the Medicinal Mondamin X-9N group and 0.1% (95% CI: -0.3 to 0.6) in the A2Care mouthwash group, and there were no significant differences between interventions. Clinical condition scale was 0 in all subjects at each time point (in the morning at Day 2 and Day 7 or final day of recuperation).

In this study, we examined the effects of the use of Medicinal Mondamin X-9N or the A2Care mouthwash on the salivary SARS-CoV-2 viral load in COVID-19 patients. Compared to the placebo group, the use of the Medicinal Mondamin X-9N and the A2Care mouthwash did not lead to a significant reduction in the salivary SARS-CoV-2 viral load. Future studies with larger sample sizes and well-designed RCTs in multiple populations and settings are warranted.

April. 15, 2023

No

NA

https://jrct.niph.go.jp/latest-detail/jRCTs051220107

Kutsuna Satoshi

Osaka University Hospital

2-15 Yamadaoka, Suita, Osaka

kutsuna@hp-infect.med.osaka-u.ac.jp

Kutsuna Satoshi

Osaka University Hospital

2-15 Yamadaoka, Suita, Osaka

+81-6-6879-5111

kutsuna@hp-infect.med.osaka-u.ac.jp

Complete

Oct. 18, 2022

Interventional

randomized controlled trial

open(masking not used)

placebo control

parallel assignment

treatment purpose

(1) Person who is diagnosed with COVID-19 using nucleic acid amplification method (PCR method, LAMP method, etc.), antigen qualitative test, antigen quantitative test
(2) Person who recuperates at an accommodation recuperation facility (a specific facility) in Osaka Prefecture, or takes home recuperation and directly followed up by the Department of Infection Control, Osaka University Hospital
(3) Person with asymptomatic or mild severity classification in the medical guide for COVID-19 (version 8.0) at informed consent
(4) Person who is scheduled to have the first day of mouthwash within 7 days from the symptom onset date (or the sample collection date for positive confirmation when asymptomatic or the onset date is not clear)
(5) Aged 18 years or older at informed consent
(6) Person who has written consent to participate in this study

(1) Person who plans to have the first day of mouthwash as the final day of recuperation
(2) Person who has difficulty collecting saliva by him/herself
(3) Person who received or is scheduled to receive remdesivir, molnupiravir, nilmatrelvir / ritnavir, sotrovimab, casilibimab / imdebimab after the onset of this COVID-19
(4) Person who received anti-IL-6 antibody (tocilizumab, etc.), JAK inhibitors (baricitinib, etc.), oral or injectable steroids within the past 2 weeks, or will be administered by the morning of the second day of mouthwash (Including administration for diseases other than COVID-19)
(5) Person who participated in clinical trials of COVID-19 therapeutic agents since the onset of this COVID-19
(6) Person with pregnant or lactating
(7) Person with a history of hypersensitivity to the ingredients of Medicinal Mondamin X-9N or A2Care Mouthwash
(8) Person who cannot meet online with the investigator using a smart phone, personal computer, etc.
(9) Person who is judged by the investigator to be inappropriate as research subjects for other reasons

Both

COVID-19

1. Medicinal Mondamin X-9N group
Put about 20 mL of Medicinal Mondamin X-9N in mouth just before each meal, wash mouth for about 20 to 30 seconds, and then spit it out.

2. A2Care Mouthwash group
Put about 10 mL of A2Care Mouthwash in mouth just before each meal, wash mouth for about 1 minute, and then spit it out.

3. Water for injection
Put about 20 mL of water for injection in mouth just before each meal, wash mouth for about 1 minute, and then spit it out.

Change in saliva SARS-CoV-2 volume at 2 hours after the first mouthwash from baseline

(1) Change in saliva SARS-CoV-2 volume at 30 minutes after the first mouthwash from baseline
(2) Change in saliva SARS-CoV-2 volume just before the mouthwash at noon of Day 1 from baseline
(3) Change in saliva SARS-CoV-2 volume just before the mouthwash at evening of Day 1 from baseline
(4) Change in saliva SARS-CoV-2 volume just before the mouthwash at morning of Day 2 from baseline
(5) Change in SpO2 at morning of Day 2 from baseline
(6) Change in clinical condition scale at morning of Day 2 from baseline
(7) Change in SpO2 at morning of Day 7 or final day of recuperation from baseline
(8) Change in clinical condition scale at morning of Day 7 or final day of recuperation from baseline

+81-6-6210-8296

Oct. 06, 2022

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