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

JRCT ID: jRCTs051220107

Registered date:18/10/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: COVID-19
• Date of first enrollment: 07/11/2022
• Target sample size: 90
• Study type: Interventional

Intervention(s)

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.

Outcome(s)

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

Secondary Outcome

(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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(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

Exclude criteria

(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

Related Information

• Primary Sponsor: Kutsuna Satoshi
• Secondary Sponsor: Onozuka Daisuke,Earth Corporation