UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040733 |
|---|---|
| Receipt number | R000046461 |
| Scientific Title | A study on the prevalence of infection in dental institutions by measuring the antibody titer to COVID-19 of the staff members of Kanagawa Dental College Medical Center |
| Date of disclosure of the study information | 2020/06/22 |
| Last modified on | 2020/06/12 15:21:53 |
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Basic information
Public title
A study on the prevalence of infection in dental institutions by measuring the antibody titer to COVID-19 of the staff members of Kanagawa Dental College Medical Center
Acronym
A study on the prevalence of infection in dental institutions by measuring the antibody titer to COVID-19 of the staff members of Kanagawa Dental College Medical Center
Scientific Title
A study on the prevalence of infection in dental institutions by measuring the antibody titer to COVID-19 of the staff members of Kanagawa Dental College Medical Center
Scientific Title:Acronym
A study on the prevalence of infection in dental institutions by measuring the antibody titer to COVID-19 of the staff members of Kanagawa Dental College Medical Center
Region
| Japan |
Condition
Condition
COVID-19
Classification by specialty
| Infectious disease | Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examine the existence of antibodies against COVID-19 in dental staff and confirm the current status of actual immunity
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Examine the presence of IgG and IgM in adaptive immunity and IgA in innate immunity against COVID-19.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
The collected saliva is treated with a treatment solution, and the COVID-19 PCR test is performed.Detect IgG and IgM by immunochromatography using a small blood sample collected from the fingertip.Saliva is collected with a saliva collection tube and IgA antibody level is analyzed by ELISA
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Hospital worker COVID-19 PCR test negative
Key exclusion criteria
Hospital worker COVID-19 PCR test positive
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Keiichi |
| Middle name | |
| Last name | Tsukinoki |
Organization
Graduate School of Dentistry, Kanagawa Dental University
Division name
Department of Oral Science
Zip code
238-8580
Address
82 Inaoka-cho, Yokosuka, Kanagawa
TEL
046-822-8866
tsukinoki@kdu.ac.jp
Public contact
Name of contact person
| 1st name | Keisuke |
| Middle name | |
| Last name | Handa |
Organization
Graduate School of Dentistry, Kanagawa Dental University
Division name
Department of Oral Science
Zip code
238-8580
Address
82 Inaoka-cho, Yokosuka, Kanagawa
TEL
046-822-8840
Homepage URL
handa@kdu.ac.jp
Sponsor or person
Institute
Kanagawa Dental University
Institute
Department
Personal name
Funding Source
Organization
Kanagawa Dental University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kanagawa Dental University
Address
82 Inaoka-cho, Yokosuka, Kanagawa
Tel
046-822-8813
kenkyo@kdu.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
神奈川歯科大学付属病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 06 | 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
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
Preinitiation
Date of protocol fixation
| 2020 | Year | 06 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 06 | Month | 22 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 06 | Month | 12 | Day |
Last modified on
| 2020 | Year | 06 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046461
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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