UMIN-CTR Clinical Trial

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
Institute	Keio University School of Medicine
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047028