UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042477 |
|---|---|
| Receipt number | R000048432 |
| Scientific Title | Prospective research for early detection of COVID-19 pneumonia using mobile CT vehicle at specialized accommodation facilities |
| Date of disclosure of the study information | 2020/11/17 |
| Last modified on | 2021/10/10 17:33:32 |
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Basic information
Public title
Prospective research for early detection of COVID-19 pneumonia using mobile CT vehicle at specialized accommodation facilities
Acronym
Prospective research for early detection of COVID-19 pneumonia using mobile CT vehicle at specialized accommodation facilities
Scientific Title
Prospective research for early detection of COVID-19 pneumonia using mobile CT vehicle at specialized accommodation facilities
Scientific Title:Acronym
Prospective research for early detection of COVID-19 pneumonia using mobile CT vehicle at specialized accommodation facilities
Region
| Japan |
Condition
Condition
COVID-19 pneumonia
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the prevalence of COVID-19 pneumonia in people infected by SARS-CoV-2 at a specialized accommodation facility
Basic objectives2
Others
Basic objectives -Others
See above
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Prevalence of COVID-19 pneumonia in people infected by SARS-CoV-2 at a specialized accommodation facility using mobile CT vehicle
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
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
To diagnose COVD-19 pneumonia using mobile CT vehicle in people who are infected by SARS-CoV-2 and staying at a specialized accommodation facility based on a written informed consent.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. People infected by SARS-CoV-2 and staying at a specialized accommodation facility
2. 20-years-old or older
3. People who gives a written informed consent.
Key exclusion criteria
(1)People who have already undergone chest CT within 48 hours of planed chest CT at a specialized accommodation facility
(2)Pregnant women
(3)People who are not suitable for this research based on medical reasons judged by medical doctors
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Tsuneo |
| Middle name | |
| Last name | Yamashiro |
Organization
Yokohama City University
Division name
Diagnostic Radiology
Zip code
236-0004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama
TEL
045-787-2696
clatsune@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Tsuneo |
| Middle name | |
| Last name | Yamashiro |
Organization
Yokohama City University
Division name
Diagnostic Radiology
Zip code
236-0004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama
TEL
045-787-2696
Homepage URL
clatsune@yahoo.co.jp
Sponsor or person
Institute
Yokohama City University
Diagnostic Radiology
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development (AMED)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
YCU Center for Novel and Exploratory Clinical Trials
Address
3-9 Fukuura, Kanazawa-ku, Yokohama
Tel
045-370-7933
nextjim1@yokohama-cu.ac.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
横浜市立大学附属病院
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 11 | Month | 17 | 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
75
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
N/A
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 11 | Month | 13 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 13 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 17 | Day |
Last follow-up date
| 2021 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2021 | Year | 07 | Month | 01 | Day |
Date trial data considered complete
| 2021 | Year | 07 | Month | 20 | Day |
Date analysis concluded
| 2021 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 11 | Month | 17 | Day |
Last modified on
| 2021 | Year | 10 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048432
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
