臨床研究実施計画・研究概要公開システム

Japanease

Date of registration	May. 01, 2020
Last modified on	Aug. 28, 2020
Trial ID	jRCTs031200026

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

Contact for Scientific Queries	Name	Kyoji Moriya
	Affiliation	The University of Tokyo Hospital
	Address	7-3-1, Hongo, Bunkyo-ku, Tokyo
	Telephone	+81-3-3815-5411
	E-mail	moriya-tky@umin.org
Contact for Public Queries	Name	Mahoko Ikeda
	Affiliation	The University of Tokyo Hospital
	Address	7-3-1, Hongo, Bunkyo-ku, Tokyo
	Telephone	+81-3-3815-5411
	E-mail	mhk-ikeda@umin.ac.jp

Date of first enrollment		June. 11, 2020
Target sample size		160
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	single blind
	control	active control
	assignment	parallel assignment
	purpose	treatment purpose
Countries of Recruitment（Except Japan）		none
Key inclusion & exclusion criteria	Inclusion Criteria	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
	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
	Age Minimum	20age old over
	Age Maximum	75age old not
	Gender	Both
Health Condition(s) or Problem(s) Studied		Coronavirus Disease 2019 (COVID-19)
Intervention(s) Code
Intervention(s) Keyword
Intervention(s)		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
Health Condition(s) Code
Health Condition(s) Keyword		COVID-19
Primary Outcome(s)		Time to alleviation of body temperature, SpO2, and chest image findings, and time to SARS-CoV-2 PCR turn negative
Secondary Outcome(s)		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

Recruitment status	Recruiting

Primary Sponsor

Primary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support	The University of Tokyo foundation (COVID-19 Emergency Action Fund)
Secondary Sponsor	Not applicable

Name of Certified Review Board	The University of Tokyo, Clinical Research Review Board
Address	7-3-1, Hongo, Bunkyo-ku, Tokyo
Telephone	+81-3-5841-0818
E-Mail	ethics@m.u-tokyo.ac.jp
Approval Status	Approval
Date of approval	April. 30, 2020

Secondary ID(s)
Issuing Authority