UMIN-CTR Clinical Trial

Basic information
Public title	Estimation of preference for selection of oral COVID-19 treatments
Acronym	Estimation of preference for selection of oral COVID-19 treatments
Scientific Title	Estimation of preference for selection of oral COVID-19 treatments
Scientific Title:Acronym	Estimation of preference for selection of oral COVID-19 treatments
Region	Japan

Condition
Condition	COVID-19
Classification by specialty	Infectious disease
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To estimate the economic value of S-217622, an oral COVID-19 treatment that is under application for approval, by investigating factors associated with the preference of treatment and differences in the preference by attributes and background of the respondents.
Basic objectives2	Others
Basic objectives -Others	preference
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Preference of factors about the oral COVID-19 treatments: dosage form and size, frequency of administration per day, number of drugs at once, number of days taking not to infect others from initiation of the treatment, developed company (domestic or foreign company), and out-of-pocket cost
Key secondary outcomes

Base
Study type	Others,meta-analysis etc

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	20 years-old <=
Age-upper limit	69 years-old >=
Gender	Male and Female
Key inclusion criteria	1. General population: 10,000 people 2. People who have been infected with SARS-CoV-2: 1,000 people: 1,000 people (if the number of respondents does not reach the target number, those between 10 and 79 years old will be included).
Key exclusion criteria	People who stop responding to the survey (not considered as respondents)
Target sample size	11000

Research contact person
Name of lead principal investigator	1st name Shinzo Middle name Last name Hiroi
Organization	Shionogi & Co., Ltd.
Division name	Medical Affairs Dept.
Zip code	541-0045
Address	3-1-8, Doshomachi, Chuo-ku, Osaka
TEL	06-6209-7412
Email	shinzo.hiroi@shionogi.co.jp

Public contact
Name of contact person	1st name Kenji Middle name Last name Kurazono
Organization	Shionogi & Co., Ltd.
Division name	Medical Affairs Dept.
Zip code	541-0045
Address	3-1-8, Doshomachi, Chuo-ku, Osaka
TEL	06-6209-7412
Homepage URL
Email	kenji.kurazono@shionogi.co.jp

Sponsor
Institute	Shionogi & Co., Ltd.
Institute
Department

Funding Source
Organization	Shionogi & Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	RIHDS Ethical Review Board
Address	12th Floor, Suitomo Shiba Daimon Building, 2-5-5 Shiba Daimon, Minato-ku, Tokyo, Japan
Tel	03-5733-5010
Email	rihds@jmdc.co.jp

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	2022 Year 08 Month 02 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2022 Year 07 Month 04 Day
Date of IRB	2022 Year 07 Month 29 Day
Anticipated trial start date	2022 Year 08 Month 05 Day
Last follow-up date	2022 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	A questionnaire survey will be performed for the eligible people in a research panel in a research company. The results of the survey will be analyzed using conjoint analysis.

Management information
Registered date	2022 Year 07 Month 29 Day
Last modified on	2022 Year 07 Month 29 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054847

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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