UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040409 |
|---|---|
| Receipt number | R000046113 |
| Scientific Title | Study of International Clinical Data Collection, Doctor to Doctor Telemedicine, education, and AI platform against deterioration of COVID-19 |
| Date of disclosure of the study information | 2020/07/01 |
| Last modified on | 2022/11/16 09:12:00 |
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Basic information
Public title
Study of International Clinical Data Collection, Doctor to Doctor Telemedicine, education, and AI platform against deterioration of COVID-19
Acronym
Study of International Clinical Data Collection, Doctor to Doctor Telemedicine, education, and AI platform against deterioration of COVID-19
Scientific Title
Study of International Clinical Data Collection, Doctor to Doctor Telemedicine, education, and AI platform against deterioration of COVID-19
Scientific Title:Acronym
Study of International Clinical Data Collection, Doctor to Doctor Telemedicine, education, and AI platform against deterioration of COVID-19
Region
| Japan | South America | Europe |
Condition
Condition
Coronavirus disease 2019
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to construct a severe disease prediction AI to detect the severe disease prediction cases quickly during the course of patients with new coronavirus infection, and the clinical information at the very early stage when COVID-19 was diagnosed. It is to build a mechanism that can predict the aggravation including the prognosis in real time from (basic patient information, vital signs, inflammatory biomarkers, chest CT). In addition, "Teaching Files" will be updated from chest CT images, prognosis data, etc. accumulated at the same time, which will be useful for knowledge sharing and education at medical institutions.
Basic objectives2
Others
Basic objectives -Others
In this study, A. Creation of database for analysis of 1000 cases or more, B. AI development for prediction of severity and creation of Teaching Files for educational purposes, C. Improvement of medical platform (Join, Team, MySOS), commercialization, D. As international medical support, we will return the research results from clinical data from Japan and overseas to overseas medical support.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Prognosis at the end of treatment
Key secondary outcomes
Severity during treatment {Use of ventilator or extracorporeal membrane oxygenation (ECMO)}
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
COVID-19 infectious patients
Key exclusion criteria
1.Patients under the age of 20.
2.Patients who have difficulty operating the device due to dementia or higher brain dysfunction.
3.Other patients who are judged by doctors to be unable to make appropriate decisions.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Kawai |
Organization
The Jikei University School of Medicine
Division name
Division of Cardiology, Department of Internal Medicine
Zip code
105-8461
Address
3-25-8 Nishi-shimbashi, Minato-ku, Tokyo 1058461, Japan.
TEL
03-3433-1111
cadmk@jikei.ac.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Kawai |
Organization
The Jikei University School of Medicine
Division name
Division of Cardiology, Department of Internal Medicine
Zip code
105-8461
Address
3-25-8 Nishi-shimbashi, Minato-ku, Tokyo 1058461, Japan
TEL
03-3433-1111
Homepage URL
cadmk@jikei.ac.jp
Sponsor or person
Institute
The Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
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
The ethics committee of The Jikei University School of Medicine
Address
3-25-8 Nishi-shimbashi, Minato-ku, Tokyo 1058461, Japan
Tel
03-3433-1111
rinri@jikei.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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 07 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2020 | Year | 05 | Month | 15 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 06 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 20 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 07 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 07 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 07 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 07 | Day |
Other
Other related information
none
Management information
Registered date
| 2020 | Year | 05 | Month | 15 | Day |
Last modified on
| 2022 | Year | 11 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046113
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
