UMIN-CTR Clinical Trial

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
Email	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/
Email	t-tagami@nms.ac.jp

Sponsor
Institute	Nippon Medical School Musashikosugi Hospital
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000053681