Combination therapy of Favipiravir and Nafamostat Mesilate in Patients with COVID-19 Pneumonia

Multicenter, Single blinded Randomized Controlled, Comparative Study to Evaluate the Efficacy and Safety of Favipiravir and Nafamostat Mesilate in Patients with COVID-19 Pneumonia

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs031200026

Enrollment

Registered

2020-05-01

Start date

2020-06-11

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

COVID-19 patients are randomly assigned to the group which adds Favipiravir and Nafamostat Mesilate to standard treatment or the group which add Favipiravir to standard treatment

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients who have given written consent to participate in the study 2) SARS-CoV-2 test positive 3) Patients with pneumonia on chest image 4) Patients with fever over 37.5 degrees 5) Pregnancy test-negative

Exclusion criteria

Exclusion criteria: 1) Patients with fever over 37.5 degrees for more than 10 days 2) Patients having less than 93% of oxygen saturation (SpO2) in without the oxygen administration 3) Patients having cardiac dysfunctions such as congestive heart failure, having severe liver dysfunction, and having renal dysfunction requiring dialysis 4) Patients having history of gout or currently undergoing treatment of gout or hyperuricemia 5) Patients having disorders of consciousness such as disorientation 6) Patients who are pregnant or who may be pregnant 7)Patients who are suspected to have an infection with a microorganism other than SARS-COV-2, causative organism of pneumonia. 8) Patients with hyperkalemia or hyponatremia 9) Patients who are considered inappropriate for inclusion in the study by the investigator

Design outcomes

Primary

Measure	Time frame
Change in patient condition on a 10-point scale from baseline to day7	—

Secondary

Measure	Time frame
1) Change in patient condition on a 10-point scale from baseline to day4 and day8 2) Change in SARS-CoV-2 viral load 3) Duration of fever and respiratory symptom 4) Change of clinical manifestations 5) Change of vital signs 6) Change of NEWS (National Early Warning Score) 7) Remission rate of chest image findings 8) Ratio of patients who required oxygen administration and mean duration of oxygen administration 9) Ratio of patients who required mechanical ventilation and mean duration of mechanical ventilation 10) Change of WBC count, hemoglobin, platelet count, creatinine, blood glucose, total bilirubin, ALT, PT, APTT,and D-dimer	—

Measure

Time frame

1) Change in patient condition on a 10-point scale from baseline to day4 and day8 2) Change in SARS-CoV-2 viral load 3) Duration of fever and respiratory symptom 4) Change of clinical manifestations 5) Change of vital signs 6) Change of NEWS (National Early Warning Score) 7) Remission rate of chest image findings 8) Ratio of patients who required oxygen administration and mean duration of oxygen administration 9) Ratio of patients who required mechanical ventilation and mean duration of mechanical ventilation 10) Change of WBC count, hemoglobin, platelet count, creatinine, blood glucose, total bilirubin, ALT, PT, APTT,and D-dimer

—

Contacts

Public ContactOkugawa Shu

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