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临床试验/JPRN-jRCTs051220107
JPRN-jRCTs051220107已完成Unknown

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

Kutsuna Satoshi0 个研究点目标入组 95 人开始时间: 2022年10月18日最近更新:

试验速览

阶段
Unknown
状态
已完成
发起方
入组人数
95

研究概览

简要总结

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.

研究设计

研究类型
Interventional

入排标准

年龄范围
>= 18age old 至 ot applicable(—)
性别
All

入选标准

  • (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

排除标准

  • (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

研究者

发起方
Kutsuna Satoshi

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