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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053681