臨床研究実施計画・研究概要公開システム

Scientific Title	A prospective multi-center open trial to evaluate the safety and efficacy of favipiravir in patients infected with COVID-19.
Public Title	Favipiravir in patients infected with COVID-19

Contact for Scientific Queries	Name	Tokue Yutaka
	Affiliation	Gunma Universty Hospital
	Address	3-39-15 Showa-mchi, Maebashi-shi, Gunma
	Telephone	+81-27-220-8549
	E-mail	tokue49@gmail.com
Contact for Public Queries	Name	Nakamura Tetsuya
	Affiliation	Gunma Universty Hospital
	Address	3-39-15 Showa-mchi, Maebashi-shi, Gunma
	Telephone	+81-27-220-8740
	E-mail	nakamurt@gunma-u.ac.jp

Date of first enrollment		Mar. 14, 2020
Target sample size		100
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
Countries of Recruitment（Except Japan）		none
Key inclusion & exclusion criteria	Inclusion Criteria	positive result for COVID-19 detection test fever above 37.5 degree Celsius, or pneumonia shadow on chest X-ray or CT-scan hospital admission
	Exclusion Criteria	pregnancy lactation
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		patients infected with COVID-19
Intervention(s) Code
Intervention(s) Keyword
Intervention(s)		oral administration of favipiravir
Health Condition(s) Code
Health Condition(s) Keyword		Coronavirus
Primary Outcome(s)		expected value and 95% CI of ratio of C-reactive protein before versus after the treatment
Secondary Outcome(s)		disappearance rate of COVID-19

Recruitment status	Recruiting

Primary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Gunma University Hospital Clinical Research Review Board
Address	3-39-15 Showa-mchi, Maebashi-shi, Gunma
Telephone	+81-27-220-8740
E-Mail	irb-jimukk-ciru@ml.gunma-u.ac.jp
Approval Status	Approval
Date of approval	Feb. 26, 2020

Plan to share IPD
Plan description

Secondary ID(s)
Issuing Authority