UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041186
Receipt number R000047028
Scientific Title Survey of Coronavirus disease 2019(COVID-19)
Date of disclosure of the study information 2020/07/23
Last modified on 2020/07/22 02:22:54

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Basic information

Public title

Survey of Coronavirus disease 2019(COVID-19)

Acronym

Survey of Coronavirus disease 2019(COVID-19)

Scientific Title

Survey of Coronavirus disease 2019(COVID-19)

Scientific Title:Acronym

Survey of Coronavirus disease 2019(COVID-19)

Region

Japan


Condition

Condition

COVID-19

Classification by specialty

Medicine in general Pneumology Infectious disease

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To conduct a fact-finding survey of COVID-19 (including suspected cases) by accumulating clinical information.

Basic objectives2

Others

Basic objectives -Others

To identify the risk factors of death from COVID-19.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Investigation of clinical characteristics of COVID-19 (e.g.clarification of risk factors for progression of COVID-19).

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

Individuals with COVID-19 (including suspected patients)

Key exclusion criteria

Patients who did not agree participation of the study by opt out or clearly refuse its participation.

Target sample size

2000


Research contact person

Name of lead principal investigator

1st name Koichi
Middle name
Last name Fukunaga

Organization

Keio University School of Medicine

Division name

Division of Pulmonary Medicine, Department of Medicine

Zip code

1608582

Address

35 Shinanomachi, Shinjuku-ku, Tokyo, Japan

TEL

0333531211

Email

kfukunaga@keio.jp


Public contact

Name of contact person

1st name Makoto
Middle name
Last name Ishii

Organization

Keio University School of Medicine

Division name

Division of Pulmonary Medicine,Department of Medicine

Zip code

1608582

Address

Shinanomachi 35, Shinjuku-ku, Tokyo, Japan

TEL

0333531211

Homepage URL


Email

ishii@keio.jp


Sponsor or person

Institute

Keio University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Self funding

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Keio University School of Medicine

Address

35 Shinanomachi, Shinuku-ku, Tokyo, Japan

Tel

0333531211

Email

natsuko.chiba@adst.keio.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 23 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

Enrolling by invitation

Date of protocol fixation

2020 Year 05 Month 29 Day

Date of IRB

2020 Year 05 Month 29 Day

Anticipated trial start date

2020 Year 05 Month 29 Day

Last follow-up date

2030 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

This study is a retrospective multicenter study.


Management information

Registered date

2020 Year 07 Month 22 Day

Last modified on

2020 Year 07 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047028


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name