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

Exploratory research for consideration of virus inhibitory effect, safety and optimal dose of nafamostat mesilate in early mild COVID-19 patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs031210183
Enrollment
30
Registered
2021-07-05
Start date
2022-01-17
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronavirus Disease 2019(COVID-19) COVID-19

Interventions

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 tre

Sponsors

Okugawa Shu
Lead Sponsor
Moriya Kyoji
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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

Design outcomes

Primary

MeasureTime frame
AUC of SARS-CoV-2 virus reduction in the nasopharynx from before the start of treatment to the 6th day of treatment

Secondary

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

Contacts

Public ContactShu Okugawa

The University of Tokyo Hospital

okugawa-tky@g.ecc.u-tokyo.ac.jp+81-3-3815-5411

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026