UMIN-CTR Clinical Trial

Public title

Investigation on the effect of favipiravir in preventing Ebola virus disease and its safety

Acronym

Prophylactic effect of favipiravir on Ebola virus disease

Scientific Title

Investigation on the effect of favipiravir in preventing Ebola virus disease and its safety

Scientific Title:Acronym

Prophylactic effect of favipiravir on Ebola virus disease

Region

Japan

Condition

Ebola virus disease

Classification by specialty

Infectious disease

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

Presence or absence of Ebola virus disease at the end of study or at discontinuation

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Yasuyuki Kato

Organization

National Center for Global Health and Medicine

Division name

Division of Preparedness and Emerging Infections, Disease Control and Prevention Center

Zip code

Address

1-21-1 Toyama, Shinjuku-ku, Tokyo 162-8655, Japan

TEL

03-3202-7181

Email

ykato@hosp.ncgm.go.jp

Name of contact person

1st name
Middle name
Last name	Yasuyuki Kato

Organization

National Center for Global Health and Medicine

Division name

Division of Preparedness and Emerging Infections, Disease Control and Prevention Center

Zip code

Address

1-21-1 Toyama, Shinjuku-ku, Tokyo 162-8655, Japan

TEL

03-3202-7181

Homepage URL

Email

ykato@hosp.ncgm.go.jp

Institute

National Center for Global Health and Medicine

Institute

Department

Personal name

Organization

Ministry of Health, Labour and Welfare, Japan

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2015

Year

01

Month

02

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2014

Year

11

Month

17

Day

Date of IRB

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

Other related information

Registered date

2015

Year

01

Month

02

Day

Last modified on

2017

Year

11

Month

15

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018700