UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039997 |
|---|---|
| Receipt number | 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 | 2022/01/23 12:04:58 |
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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
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
ireef@jichi.ac.jp
Sponsor or person
Institute
Jichi Medical University
Division of Gastroenterology
Institute
Department
Personal name
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
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
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
382
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
| 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 | 03 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 06 | Month | 01 | Day |
Other
Other related information
A total of 382 subjects were enrolled.
Management information
Registered date
| 2020 | Year | 03 | Month | 31 | Day |
Last modified on
| 2022 | Year | 01 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045600
| Research Plan | |
|---|---|
| Registered date | File name |
| 2022/01/23 | コロナ臨床研究計画書20210124.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2022/01/23 | DEN Open - 2021 - Miura - Low prevalence of SARS%E2%80%90CoV%E2%80%902 specific antibodies among endoscopists and their assistants in a.pdf |
| Research case data | |
|---|---|
| Registered date | File name |
| 2022/01/23 | DEN Open - 2021 - Miura - Low prevalence of SARS%E2%80%90CoV%E2%80%902 specific antibodies among endoscopists and their assistants in a.pdf |
