Exploratory research of nafamostat mesilate in early mild COVID-19 patients

JRCT ID: jRCTs031210183

Registered date:05/07/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Coronavirus Disease 2019(COVID-19)
• Date of first enrollment: 17/01/2022
• Target sample size: 30
• Study type: Interventional

Intervention(s)

Patients with COVID-19 will be randomly assigned to any of the following groups:
-Standard treatment group
-Standard treatment +nafamostat mesilate 0.2mg/kg/hr group, 6 days(110-120hrs)
-Standard treatment +nafamostat mesilate 0.1mg/kg/hr group, 6 days(110-120hrs)

Outcome(s)

• Primary Outcome: AUC of SARS-CoV-2 virus reduction in the nasopharynx from before the start of treatment to the 6th day of treatment

Secondary Outcome

1)Change of clinical symptoms (vital sign, SpO2)
2)Amount of change in patient condition on a 10-point scale
3) Logarithmic viral load

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

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

Exclude criteria

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

Related Information

• Primary Sponsor: Okugawa Shu
• Secondary Sponsor: Moriya Kyoji
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development