UMIN-CTR Clinical Trial

Basic information
Public title	A study of changes in emergency department patient dynamics during the COVID-19 outbreak
Acronym	COVID-19 Outbreak in Emergency Department
Scientific Title	A study of changes in emergency department patient dynamics during the COVID-19 outbreak
Scientific Title:Acronym	COVID-19 Outbreak in Emergency Department
Region	Japan

Condition
Condition	COVID-19
Classification by specialty	Emergency medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To determine the impact of non-pharmaceutical interventions to prevent the spread of novel coronavirus infections in Japan on emergency care.
Basic objectives2	Others
Basic objectives -Others	To determine the impact of the novel coronavirus infection on the dynamics of patients seen in our hospital's emergency department.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Comparison of the number of patients seen in the year of the new coronavirus outbreak and the average number of patients seen over a five-year period
Key secondary outcomes	Incidence of new coronavirus infection in the year of the new coronavirus outbreak. Comparison of the yearly incidence of novel coronavirus infection and the proportion of emergency cases seen by average patients over a five-year period. Comparison between the year of the new coronavirus outbreak and the average number of patients seen over a five-year period.

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 in the emergency room
Key exclusion criteria	none
Target sample size	100000

Research contact person
Name of lead principal investigator	1st name Hiroshi Middle name Last name Yamagami
Organization	Shonan Kamakura General Hospital
Division name	Department of Emergency Medicine
Zip code	2470072
Address	1370-1 Okamoto, Kamakura city, Kanagawa
TEL	+81-467-46-1717
Email	defender8chan@yahoo.co.jp

Public contact
Name of contact person	1st name Ichiro Middle name Last name Sekine
Organization	Shonan Kamakura General Hospital
Division name	Department of Emergency Medicine
Zip code	2470072
Address	1370-1 Okamoto, Kamakura city, Kanagawa
TEL	+81-467-46-1717
Homepage URL
Email	ichirosekine@yahoo.co.jp

Sponsor
Institute	Shonan Kamakura General Hospital
Institute
Department

Funding Source
Organization	Shonan Kamakura General Hospital
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	none
Address	none
Tel	none
Email	none

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 12 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	https://onlinelibrary.wiley.com/doi/10.1002/ams2.603
Number of participants that the trial has enrolled	109429
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	Completed
Date of protocol fixation	2015 Year 01 Month 01 Day
Date of IRB	2020 Year 08 Month 26 Day
Anticipated trial start date	2015 Year 01 Month 01 Day
Last follow-up date	2020 Year 09 Month 29 Day
Date of closure to data entry	2020 Year 09 Month 30 Day
Date trial data considered complete	2020 Year 09 Month 30 Day
Date analysis concluded	2020 Year 09 Month 30 Day

Other
Other related information	none

Management information
Registered date	2020 Year 07 Month 12 Day
Last modified on	2021 Year 06 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000046864