UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039873 |
|---|---|
| Receipt number | R000045453 |
| Scientific Title | COVID-19 Registry |
| Date of disclosure of the study information | 2020/03/19 |
| Last modified on | 2024/03/29 21:07:36 |
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Basic information
Public title
COVID-19 Registry
Acronym
COVID-19 Registry
Scientific Title
COVID-19 Registry
Scientific Title:Acronym
COVID-19 Registry
Region
| Japan |
Condition
Condition
COVID-19
Classification by specialty
| Pneumology | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective is to collect the following data. This is a study to develop a registry and specific analytical details are not decided.
-Clinical characteristics of COVID-19 cases in Japan
-Clinical Characteristics of cases with various severity
-Efficacy and safety evaluation on treatments and supportive therapies
Basic objectives2
Others
Basic objectives -Others
To investigate the effect and safety profile of various therapeutic agents administered for COVID-19.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
none
Key secondary outcomes
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
Patients diagnosed with COVID-19 and was hospitalized
Key exclusion criteria
Those who refused to participate in the study by opt-out
Target sample size
99999
Research contact person
Name of lead principal investigator
| 1st name | Norio |
| Middle name | |
| Last name | Ohmagari |
Organization
Center Hospital of the National Center for Global Health and Medicine
Division name
Disease Control and Prevention Center
Zip code
162-8655
Address
1-21-1, Toyama, Shinjuku-ku, Japan
TEL
0332027181
registry.covid@hosp.ncgm.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | COVIREGI study office |
Organization
National Center for Global Health and Medicine
Division name
Disease Control and Prevention Center
Zip code
162-8655
Address
1-21-1, Toyama, Shinjuku-ku, Japan
TEL
0332027181
Homepage URL
https://covid-registry.ncgm.go.jp/
registry.covid@hosp.ncgm.go.jp
Sponsor or person
Institute
National Center for Global Health and Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labor and Welfare
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
Ethics Review Board of National Center for Global Health and Medicine
Address
1-21-1 Toyama, shinzyuku,Tokyo 162-8655, Japan
Tel
0332027181
kenkyu-shinsa@hosp.ncgm.go.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 | 03 | Month | 19 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 02 | Month | 27 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 02 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 19 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
This study intends to collect medical information on COVID patients and build a patient registry. https://covid-registry.ncgm.go.jp/
Management information
Registered date
| 2020 | Year | 03 | Month | 19 | Day |
Last modified on
| 2024 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045453
