Exploratory research of nafamostat mesilate in early mild COVID-19 patients
- Conditions
- Coronavirus Disease 2019(COVID-19)COVID-19
- Registration Number
- JPRN-jRCTs031210183
- Lead Sponsor
- Okugawa Shu
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 30
1)Patients who have given written consent to participate in the study
2)SARS-CoV-2 PCR Positive
3) Patients in need of inpatient treatment
4)Patents with no obvious pneumonia on chest images
5)Patients who are hospitalized and can start study drug administration within 5days after the onset of COVID-19 symptoms
1)Patients with recurrence or reinfection of COVID-19
2) Patients who are asymptomatic or whose onset date of various symptoms due to COVID-19 cannot be specified
3) Patients suspected of having infection with microorganisms other than SARS-CoV-2 requiring treatment
4) Patients with hyperkalemia or hyponatremia
5) Patients undergoing or planning treatment for malignant tumors
6) Patients with severe liver dysfunction or renal dysfunction requiring dialysis
7) Patients with impaired consciousness such as disorientation
8)Patients who are pregnant or who may be pregnant
9) Patients with weakened immune system
10)Patients with a history of hypersensitivity to Nafamostat Mesilate
11)Patients who are considered inappropriate for inclusion in the study by the investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method AUC of SARS-CoV-2 virus reduction in the nasopharynx from before the start of treatment to the 6th day of treatment
- Secondary Outcome Measures
Name Time Method 1)Change of clinical symptoms (vital sign, SpO2)<br>2)Amount of change in patient condition on a 10-point scale<br>3) Logarithmic viral load