Camostat Mesilate contained oral wash trial

JRCT ID: jRCTs031200113

Registered date:10/09/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Not applicable
• Date of first enrollment: 01/09/2021
• Target sample size: 400
• Study type: Interventional

Intervention(s)

Group I: 5.75 mg of camostat mesylate and 394.25 mg of lactose as excipients are dissolved in a 100ml Tap water and wash the mouth 4 times a day for 56 days.
Group II: Dissolve only 400 mg of lactose in a 100 ml Tap water and wash the mouth 4 times a day for 56 days.

Outcome(s)

• Primary Outcome: SARS-CoV-2 PCR test
• Secondary Outcome: Age, gender, life history (question),Blood biochemical test, Chest CT(if perfomed)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 75age old
• Gender: Both

Include criteria

1.Gender: Any
2.Age: 20 and over, under 75
3. Independent living possible person
4.Persons who can reliably answer questions, measure body temperature, and observe health
5.Persons who understand this research and complete the consent form
6.Persons who have been confirmed negative by PCR test

Exclude criteria

1.Persons who do not meet the selection criteria
2.Persons who have been infected with SARS-CoV-2 within 3 months
3.Persons who have had close contact with SARS-CoV-2 infected persons within 2 weeks
4.Persons who are taking Camostat Mesilate tablets due to chronic pancreatitis, etc.
5.Persons who are at risk of developing allergies related to this study
6.Persons with symptoms such as fever, sore throat, cough, dysgeusia, olfactory sensation, and diarrhea within 3 weeks
7.Persons who are currently participating in some clinical trial or who participated within 2 months before the start of the trial
8.Persons who are judged to be unsuitable by the principal investigator and the investigators

Related Information

• Primary Sponsor: Nishizaki Yasuriro