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

JRCT ID: jRCTs031230566

Registered date:12/01/2024

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: COVID-19
• Date of first enrollment: 14/01/2024
• Target sample size: 66
• Study type: Interventional

Intervention(s)

1. Medicinal Mondamin X-9N group
Put about 20 mL of Medicinal Mondamin X-9N in mouth , wash mouth for about 20 to 30 sec, and then spit it out.
2. A2Care Mouthwash group
Put about 9 mL of A2Care Mouthwash in mouth, wash mouth for about 20 to 30 sec, and then spit it out.
3. Water for injection
Put about 20 mL of water for injection in mouth , wash mouth for about 20 to 30 sec, and then spit it out.

Outcome(s)

• Primary Outcome: Change in saliva SARS-CoV-2 volume at 60 min after the mouthwash from baseline

Secondary Outcome

(1)Change in saliva SARS-CoV-2 volume at 10 min after the mouthwash from baseline
(2)Change in saliva SARS-CoV-2 volume at 30 min after the mouthwash 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 with mild severity class ification in the medical guide for COVID-19 (version 10.0) at informed consent
(3) Person who is scheduled to have the day of mouthwash within 3 days from the symptom onset date (or the sample collection date for positive confirmation when asymptomatic or the onset date is not clear)
(4) Aged 18 years or older at informed consent
(5) Person who has written consent to participate in this study

Exclude criteria

(1) Person who has difficulty collecting saliva by him/herself due to the effects of old age, Sjogren's syndrome, radiation therapy for malignant tumors, etc.
(2) Person who received or is scheduled to receive remdesivir, molnupiravir, nilmatrelvir / ritnavir, Ensitrelvir,sotrovimab, casilibimab / imdebimab,Tixagevimab/Cilgavimab after the onset of this COVID-19
(3) 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 day of mouthwash (Including administration for diseases other than COVID-19)
(4) Person who participated in clinical trials of COVID-19 therapeutic agents since the onset of this
COVID-19
(5) Person with pregnant or lactating
(6) Person with a history of hypersensitivity to the ingredients of Medicinal Mondamin X-9N or A2Car
e Mouthwash
(7) Person who is judged by the investigator to be inappropriate as research subjects for other reaso
ns

Related Information

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