Japanease

May. 01, 2020

July. 02, 2020

jRCTs031200026

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

+81-3-3815-5411

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

160

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 PCR 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

20age old over
75age old not

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

Time to alleviation of body temperature, SpO2, and chest image findings, and time to SARS-CoV-2 PCR turn negative

1) Change in patient condition on a 7-point scale
2) Time to SARS-CoV-2 viral clearance
3) Duration of fever
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

The University of Tokyo foundation (COVID-19 Emergency Action Fund)
Not applicable
The University of Tokyo, Clinical Research Review Board
7-3-1, Hongo, Bunkyo-ku, Tokyo

+81-3-5841-0818

ethics@m.u-tokyo.ac.jp
Approval

April. 30, 2020