UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048518 |
|---|---|
| Receipt number | R000054847 |
| Scientific Title | Estimation of preference for selection of oral COVID-19 treatments |
| Date of disclosure of the study information | 2022/08/02 |
| Last modified on | 2023/06/21 14:34:14 |
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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
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
kenji.kurazono@shionogi.co.jp
Sponsor or person
Institute
Shionogi & Co., Ltd.
Institute
Department
Personal name
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
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
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s12325-023-02564-4
Number of participants that the trial has enrolled
11303
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
Completed
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
| 2023 | Year | 06 | Month | 21 | Day |
Link to view the page
Value
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 |
