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

Phase 3

• Conditions: COVID-19; Coronavirus Disease 2019 (COVID-19)

• Registration Number: JPRN-jRCTs031200026
• Lead Sponsor: Shu Okugawa

Brief Summary

afamostat combined with favipiravir did not improve clinical progression. However, early defervescence and recovery of SpO2 were observed in the combination group.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-05-01
• Study Completion: 2021-10-04
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 45

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in patient condition on a 10-point scale from baseline to day7

Secondary Outcome Measures

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