臨床研究実施計画・研究概要公開システム

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

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

Kyoji Moriya

The University of Tokyo Hospital

7-3-1, Hongo, Bunkyo-ku, Tokyo

moriya-tky@umin.org

Mahoko Ikeda

The University of Tokyo Hospital

7-3-1, Hongo, Bunkyo-ku, Tokyo

+81-3-3815-5411

mhk-ikeda@umin.ac.jp

June. 11, 2020

Interventional

randomized controlled trial

single blind

active control

parallel assignment

treatment purpose

none

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

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

Both

Coronavirus Disease 2019 (COVID-19)

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

COVID-19

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

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

Recruiting

+81-3-5841-0818

April. 30, 2020

No