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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000040219
Receipt No. R000045877
Scientific Title A prospective cohort study to follow the health status of medical staff engage in COVID-19
Date of disclosure of the study information 2020/04/22
Last modified on 2020/06/08

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Basic information
Public title A prospective cohort study to follow the health status of medical staff engage in COVID-19
Acronym A prospective cohort study to medical staff engage in COVID-19
Scientific Title A prospective cohort study to follow the health status of medical staff engage in COVID-19
Scientific Title:Acronym A prospective cohort study to medical staff engage in COVID-19
Region
Japan

Condition
Condition medical staff engage in COVID-19
Classification by specialty
Medicine in general Infectious disease Emergency medicine
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To follow up the health status of medical stuff engage in COVID-19
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The change of COVID-19 markers in medical staff engage in COVID-19
Key secondary outcomes The health status of medical staff engage in COVID-19

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria medical staffs engaged in COVID-19 in Yokohama City University
Key exclusion criteria not willing to participate the study
judged as being inappropriate candidates for the trial by the investigators
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Takuma
Middle name
Last name HIGURASHI
Organization Yokohama City University
Division name Department of gastroenterology and hepatology
Zip code 236-0004
Address 3-9 Fukuura, Kanazawaku, Yokohama, Kanagawa, Japan
TEL 045-787-2800
Email takuma_h@yokohama-cu.ac.jp

Public contact
Name of contact person
1st name Takuma
Middle name
Last name HIGURASHI
Organization Yokohama City University
Division name Department of gastroenterology and hepatology
Zip code 236-0004
Address 3-9 Fukuura, Kanazawaku, Yokohama, Kanagawa, Japan
TEL 045-787-2800
Homepage URL
Email takuma_h@yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University
Institute
Department

Funding Source
Organization Self funding
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 Yokohama City University Hospital IRB
Address 3-9 Fukuura, Kanazawaku, Yokohama, Kanagawa, Japan
Tel 045-370-7627
Email rinri@yokohama-cu.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 横浜市立大学附属病院(神奈川県)

Other administrative information
Date of disclosure of the study information
2020 Year 04 Month 22 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 35
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 No longer recruiting
Date of protocol fixation
2020 Year 04 Month 21 Day
Date of IRB
2020 Year 04 Month 22 Day
Anticipated trial start date
2020 Year 04 Month 23 Day
Last follow-up date
2020 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information N/A

Management information
Registered date
2020 Year 04 Month 22 Day
Last modified on
2020 Year 06 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045877

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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