UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation on the effect of favipiravir in preventing Ebola virus disease and its safety
Title of the study (Brief title)	Prophylactic effect of favipiravir on Ebola virus disease
Region	Japan

Condition
Condition	Ebola virus disease
Classification by specialty	Infectious disease
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the preventive effect and safety of favipiravir in persons who had high risk exposure to Ebola virus
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Presence or absence of Ebola virus disease at the end of study or at discontinuation
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Favipiravir is given for 14 days after study initiation.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Persons who met all of the following criteria is enrolled in the study. 1. Among those who experienced one of the following events (A-D) of Ebola virus exposure, the Case Management Committee evaluates the appropriateness of the subject for this study. A Penetration of skin by sharps contaminated with blood or body fluids of an Ebola virus-infected patient (e.g. needle stick injury). B Contamination of mucous membrane or broken skin with blood or body fluids of an Ebola virus-infected patient. C Performing aerosol-producing procedure (e.g. cardiopulmonary resuscitation) on an Ebola virus-infected patient without use of appropriate personal protective equipment. D Prolonged (for hours) contact with an Ebola virus-infected patient in an enclosed space like an aircraft cabin without use of appropriate personal protective equipment. 2. Principally, male and female aged 20 years or older. However, even minors are allowed to participate in the study only when his/her doctor understands the significance of the post-exposure treatment provided in this study. 3. Persons aged 20 years or older who submitted informed consent. Proxy consent is acceptable in case the person is incompetent to consent to the contract. For those under 20 years old, written consent of both the person and his/her parent (or the replacement) is required for junior-high and high school students. For primary school children or younger, written consent of his/her parent (or the replacement) is required.
Key exclusion criteria	Person who conflicts any of the following criteria cannot be enrolled in the study. 1. Person who has a high fever 2. Person who was considered as inadequate for this study by the Case Management Committee.
Target sample size	25

Research contact person
Name of lead principal investigator	Yasuyuki Kato
Organization	National Center for Global Health and Medicine
Division name	Division of Preparedness and Emerging Infections, Disease Control and Prevention Center
Address	1-21-1 Toyama, Shinjuku-ku, Tokyo 162-8655, Japan
TEL	03-3202-7181
Email	ykato@hosp.ncgm.go.jp

Public contact
Name of contact person	Yasuyuki Kato
Organization	National Center for Global Health and Medicine
Division name	Division of Preparedness and Emerging Infections, Disease Control and Prevention Center
Address	1-21-1 Toyama, Shinjuku-ku, Tokyo 162-8655, Japan
TEL	03-3202-7181
Homepage URL
Email	ykato@hosp.ncgm.go.jp

Sponsor
Institute	National Center for Global Health and Medicine
Institute
Department

Funding Source
Organization	Ministry of Health, Labour and Welfare, Japan
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2015 Year 01 Month 02 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 11 Month 17 Day
Anticipated trial start date	2015 Year 01 Month 19 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 01 Month 02 Day
Last modified on	2017 Year 11 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018700