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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000039997
Receipt No. R000045600
Scientific Title Prevention of COVID-19 infection in a medical institution and maintenance of medical system
Date of disclosure of the study information 2020/04/01
Last modified on 2020/10/08

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Basic information
Public title Prevention of COVID-19 infection in a medical institution
and maintenance of medical system
Acronym Prevention of COVID-19 infection in a medical institution
and maintenance of medical system
Scientific Title Prevention of COVID-19 infection in a medical institution
and maintenance of medical system
Scientific Title:Acronym Prevention of COVID-19 infection in a medical institution
and maintenance of medical system
Region
Japan

Condition
Condition COVID-19 infection
Classification by specialty
Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aims of this study are to clarify the positive rates of
COVID-19-related markers in medical workers and to
maintain medical system by preventing COVID-19
infection among medical workers.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The positive rates of COVID-19-related markers in
medical workers.
Key secondary outcomes The changes of COVID-19-related markers in medical
workers.

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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Medical workers in Jichi Medical University
Key exclusion criteria Medical workers who do not agree the present study
Target sample size 3700

Research contact person
Name of lead principal investigator
1st name Hironori
Middle name
Last name Yamamoto
Organization Jichi Medical University
Division name Division of Gastroenterology
Zip code 329-0498
Address 3311-1, Yakushuji, Shimotsuke, Tochigi, Japan
TEL 0285-58-7348
Email ireef@jichi.ac.jp

Public contact
Name of contact person
1st name Hironori
Middle name
Last name Yamamoto
Organization Jichi Medical University
Division name Division of Gastroenterology
Zip code 329-0498
Address 3311-1, Yakushuji, Shimotsuke, Tochigi, Japan
TEL 0285-58-7348
Homepage URL
Email ireef@jichi.ac.jp

Sponsor
Institute Jichi Medical University
Division of Gastroenterology
Institute
Department

Funding Source
Organization Jichi Medical University
Division of Gastroenterology
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 Bioethics Committee for Clinical Research A, Jichi Medical University Hospital
Address 3311-1, Yakushuji, Shimotsuke, Tochigi, Japan
Tel 0285-44-2111
Email rinri@jichi.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 04 Month 01 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 Open public recruiting
Date of protocol fixation
2020 Year 03 Month 16 Day
Date of IRB
2020 Year 03 Month 23 Day
Anticipated trial start date
2020 Year 04 Month 01 Day
Last follow-up date
2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information At present, 252 subjects were enrolled.

Management information
Registered date
2020 Year 03 Month 31 Day
Last modified on
2020 Year 10 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045600

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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