UMIN-CTR Clinical Trial

Basic information
Public title	Identifying the risk of COVID-19 between different underlying comorbidities through the collaborative effort of Core Hospitals for Clinical Research in Japan
Acronym	Identifying the risk of COVID-19 between different underlying comorbidities through the collaborative effort of Core Hospitals for Clinical Research in Japan
Scientific Title	Identifying the risk of COVID-19 between different underlying comorbidities through the collaborative effort of Core Hospitals for Clinical Research in Japan
Scientific Title:Acronym	Identifying the risk of COVID-19 between different underlying comorbidities through the collaborative effort of Core Hospitals for Clinical Research in Japan
Region	Japan

Condition
Condition	All patients who visited the participating hospitals between March 1st, 2020 and December 3st, 2020, and who meets the inclusion criteria, and not meet the exclusion criteria are included in the current study
Classification by specialty	Medicine in general Surgery in general Obsterics and gynecology Ophthalmology Dermatology Psychiatry Oto-rhino-laryngology Orthopedics Urology Radiology Neurosurgery Cardiovascular surgery Plastic surgery Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Patients who visited the participating Core Hospitals for Clinical Research will be evaluated for their risk of onset of COVID-19 and their comorbidities
Basic objectives2	Others
Basic objectives -Others	We will evaluate the feasibility of the collaborative network project among Core Hospitals for Clinical Research in gathering Real World Data and establishing Real World Evidence
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Onset 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	Patients who visited the participating institute more than twice between March 1st, 2020 and December 31st, 2020. For the patients who were positive for COVID-19, they would be enrolled in the study even with a one time visit.
Key exclusion criteria	1) Patients who declared to opt out of the study 2) patients whose data cannot be used for this study according to the participating institutes' previously defined policy (for example the patient is currently enrolled in a different clinical trial)
Target sample size	7000000

Research contact person
Name of lead principal investigator	1st name Hideyuki Middle name Last name Saya
Organization	Keio University Hospital
Division name	Clinical and Translational Research Center
Zip code	160-8582
Address	35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL	03-3353-1211
Email	hsaya@a6.keio.jp

Public contact
Name of contact person	1st name Ryo Middle name Last name Takemura
Organization	Keio University Hospital
Division name	Clinical and Translational Research Center
Zip code	160-8582
Address	35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL	03-3353-1211
Homepage URL
Email	rtakemura@keio.jp

Sponsor
Institute	Keio University Hospital
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Japanese Governmental office
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 Ethics Committee
Address	35 Shinanomachi, Shinjuku-ku, Tokyo
Tel	03-5363-3503
Email	med-rinri-jimu@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	2021 Year 02 Month 28 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	2021 Year 01 Month 07 Day
Date of IRB	2021 Year 01 Month 27 Day
Anticipated trial start date	2021 Year 03 Month 01 Day
Last follow-up date	2022 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

This is a retrospective Cohort study to assess the risk of COVID-19 infection according to underlying comorbidities. The outcome is defined as COVID-19 infection, defined by ICD10 code of U07.1 2019-nCoV acute respiratory disease. We will also collect information of the patients' underlying comorbidities from their diagnosis, as well as data on prescription, lab result, age and admission/discharge information.

Management information
Registered date	2021 Year 02 Month 22 Day
Last modified on	2022 Year 02 Month 24 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000049453