UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047056 |
|---|---|
| Receipt number | R000053681 |
| Scientific Title | J-RECOVER |
| Date of disclosure of the study information | 2022/03/02 |
| Last modified on | 2022/09/03 07:06:59 |
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Basic information
Public title
Japanese multicenter REsearch of COVID-19 by assEmbling Real-world data
Acronym
J-RECOVER
Scientific Title
J-RECOVER
Scientific Title:Acronym
J-RECOVER
Region
| Japan |
Condition
Condition
COVID-19
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to construct a database of confirmed COVID-19 cases in Japan and promptly address unresolved research issues.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
28-day mortality
mortality
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
| 1 | days-old | <= |
Age-upper limit
| 120 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with COVID-19 who had a laboratory-confirmed SARS-CoV-2 infection were eligible for this study, regardless of being admitted to the ICU.
Key exclusion criteria
out of hospital cardiac arrest patient and died at the ED.
Target sample size
4500
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Tagami |
Organization
Nippon Medical School Musashikosugi Hospital
Division name
Department of Emergency and Critical Care Medicine
Zip code
211-8533
Address
1-396 Kosugimachi, Nakahara-ku, Kawasaki, Kanagawa 211-8533, Japan
TEL
0447335181
t-tagami@nms.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Tagami |
Organization
Nippon Medical School Musashikosugi Hospital
Division name
Department of Emergency and Critical Care Medicine
Zip code
211-8533
Address
1-396 Kosugimachi, Nakahara-ku, Kawasaki, Kanagawa 211-8533, Japan
TEL
0447335181
Homepage URL
https://nms-kosugi-eccm.com/covid19-joint-research/
t-tagami@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School Musashikosugi Hospital
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nippon Medical School Musashikosugi Hospital
Address
1-396 Kosugimachi, Nakahara-ku, Kawasaki, Kanagawa 211-8533, Japan
Tel
0447335181
t-tagami@nms.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
| 2022 | Year | 03 | Month | 02 | 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
4700
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 12 | Month | 07 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 07 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We planned to conduct an analysis based on the research proposal. Overall, 66 institutions from Japan announced their participation, and 102 research proposals were selected for the analyses. Research areas from the proposals included epidemiology, pathophysiology, therapeutic agents, ventilator settings, cost-benefit analyses, and prognosis prediction for COVID-19.
Management information
Registered date
| 2022 | Year | 03 | Month | 02 | Day |
Last modified on
| 2022 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053681
