UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040033
Receipt number 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 13:18:41

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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 or person

Institute

Oita San-ai Medical Center

Institute

Department

Personal name



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

Value
https://center6.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