UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049688 |
|---|---|
| Receipt number | R000056594 |
| Scientific Title | Web-based questionnaire survey of physicians' practices and needs for an antiviral in patients with mild/moderate I COVID-19 without risk factors for disease progression |
| Date of disclosure of the study information | 2022/12/06 |
| Last modified on | 2023/03/28 15:07:30 |
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Basic information
Public title
Questionnaire survey about COVID-19 clinical practices and physicians' needs for an antiviral
Acronym
Questionnaire survey about COVID-19 clinical practices and physicians' needs for an antiviral
Scientific Title
Web-based questionnaire survey of physicians' practices and needs for an antiviral in patients with mild/moderate I COVID-19 without risk factors for disease progression
Scientific Title:Acronym
Questionnaire survey of physicians' practices and needs for antivirals in COVID-19 patients
Region
| Japan |
Condition
Condition
COVID-19
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the needs and impacts on clinical practice when an oral antiviral for these patients is available
Basic objectives2
Others
Basic objectives -Others
To confirm the current COVID-19 treatment and the burden on medical staff for mild/moderate I patients without risk factors
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Impact on clinical practice when an oral antiviral is approved for mild/moderate I patients without risk factors
-Prescription intention of an antiviral and their reasons
-Expectation to an antiviral in those patient treatments
-Impacts on the burden of health care workers
Key secondary outcomes
Information on the care of mild/moderate I patients without risk factors
-Current practice of treatment, Satisfaction of treatment
-Degree of pressure on the medical system: Impact on other medical services, lack of personnel
-Burden on healthcare workers and their factors: working hours, infection control measures, and infection risk
-Impacts when healthcare workers infected
Base
Study type
Observational
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Persons who meet the following criteria in the screening survey
-Physician working in internal medicine or respiratory medicine
-Persons who have experience in the care of more than 20 mild/moderate I COVID-19 patients without risk factors from July to October 2022
Key exclusion criteria
Not applicable
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Shinzo |
| Middle name | |
| Last name | Hiroi |
Organization
SHIONOGI & Co., Ltd.
Division name
Medical Affairs Department
Zip code
561-0045
Address
1-8, Doshomachi 3-chome, Chuo-ku, Osaka
TEL
080-2425-7440
shinzo.hiroi@shionogi.co.jp
Public contact
Name of contact person
| 1st name | Ippei |
| Middle name | |
| Last name | Morita |
Organization
SHIONOGI & Co., Ltd.
Division name
Medical Affairs Department
Zip code
561-0045
Address
1-8, Doshomachi 3-chome, Chuo-ku, Osaka
TEL
070-7812-7168
Homepage URL
ippei.morita@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
Not applicable
Address
Not applicable
Tel
-
-
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 | 12 | Month | 06 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-bin/ctr/ctr_file_dl.cgi?recptno=R000056594&file_id=00001&file_kind=1
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
464
Results
Main treatment for mild patients without risk factors was "symptomatic treatment", and there was an intention to use antivirals in the hope of "prevention of severe illness" for moderate I patients. There are some patients who complain to their physicians about the lack of antivirals, while even if it becomes possible to prescribe, half of the respondents thought "no or little benefits for patients" or "no stress of healthcare providers is alleviated" and responded to not want to use them.
Results date posted
| 2023 | Year | 03 | Month | 28 | Day |
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 | 12 | Month | 12 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 13 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 13 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
None
Management information
Registered date
| 2022 | Year | 12 | Month | 05 | Day |
Last modified on
| 2023 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056594
| Research Plan | |
|---|---|
| Registered date | File name |
| 2022/12/13 | 医師ニーズ調査研究_実施計画書 Fix.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
