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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000040033
Receipt No. R000045640
Scientific Title Nosocomial infection of coronavirus disease 2019 in the hospital without negative pressure chamber.
Date of disclosure of the study information 2020/04/02
Last modified on 2020/04/02

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Basic information
Public title Nosocomial infection of coronavirus disease 2019 in the hospital without negative pressure chamber.
Acronym Nosocomial infection of coronavirus disease 2019.
Scientific Title Nosocomial infection of coronavirus disease 2019 in the hospital without negative pressure chamber.
Scientific Title:Acronym Nosocomial infection of coronavirus disease 2019.
Region
Japan

Condition
Condition coronavirus disease 2019
Classification by specialty
Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To consider the nosocomial transmission to medical workers when the patients with coronavirus disease 2019 infection was hospitalized in the hospital without negative pressure chamber.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The period from the first hospitalization day of the patients with coronavirus disease 2019 to the first nosocomial transmission to medical workers.
Key secondary outcomes Consideration of clinical symptoms of medical workers, the number of PCR examination until the confirmation of nosocomial infection, the usefulness of questionnaire.

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
90 years-old >=
Gender Male and Female
Key inclusion criteria All medical worker in the hospital.
Key exclusion criteria None
Target sample size 300

Research contact person
Name of lead principal investigator
1st name Ryota
Middle name
Last name Sagami
Organization Oita San-ai Medical Center
Division name Department of Gastroenterology
Zip code 870-1151
Address Oaza Ichi 1213, Oita, Oita, Japan
TEL +81-97-541-1311
Email sagami1985@yahoo.co.jp

Public contact
Name of contact person
1st name Ryota
Middle name
Last name Sagami
Organization Oita San-ai Medical Center
Division name Department of Gastroenterology
Zip code 870-1151
Address Oaza Ichi 1213, Oita, Oita, Japan
TEL +81-97-541-1311
Homepage URL
Email sagami1985@yahoo.co.jp

Sponsor
Institute Oita San-ai Medical Center
Institute
Department

Funding Source
Organization None
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 Oita San-ai Medical Center
Address Oaza Ichi 1213, Oita, Oita, Japan
Tel +81-97-541-1311
Email sagami1985@yahoo.co.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 大分三愛メディカルセンター

Other administrative information
Date of disclosure of the study information
2020 Year 04 Month 02 Day

Related information
URL releasing protocol
Publication of results Partially published

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 04 Month 02 Day
Date of IRB
2020 Year 04 Month 02 Day
Anticipated trial start date
2020 Year 04 Month 02 Day
Last follow-up date
2021 Year 04 Month 02 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information None

Management information
Registered date
2020 Year 04 Month 02 Day
Last modified on
2020 Year 04 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045640

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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