UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043717 |
|---|---|
| Receipt number | R000049910 |
| Scientific Title | A study on salivary IgA crossed by SARS-CoV-2 |
| Date of disclosure of the study information | 2021/04/01 |
| Last modified on | 2022/01/14 08:50:15 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A study on salivary IgA crossed by SARS-CoV-2
Acronym
A study on salivary IgA crossed by SARS-CoV-2
Scientific Title
A study on salivary IgA crossed by SARS-CoV-2
Scientific Title:Acronym
A study on salivary IgA crossed by SARS-CoV-2
Region
| Japan |
Condition
Condition
Healthy volunteer
Classification by specialty
| Oral surgery | Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigate the relationship between a specific immunoglobulin in mucus and blood, and COVID-19
Basic objectives2
Others
Basic objectives -Others
Elucidation of the mechanism of immunity
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Immunoglobulin levels
Key secondary outcomes
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
| 3 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy males and females over 2 years old
Key exclusion criteria
none
Target sample size
190
Research contact person
Name of lead principal investigator
| 1st name | Keiichi |
| Middle name | |
| Last name | Tukinoki |
Organization
Kanagawa Dental University
Division name
Division of Environmental Pathology, Department of Oral Science
Zip code
238-8580
Address
82 Inaoka-cho, Yokosuka-shi, Kanagawa, Japan
TEL
046-822-1500
tsukinoki@kdu.ac.jp
Public contact
Name of contact person
| 1st name | Keiichi |
| Middle name | |
| Last name | Tukinoki |
Organization
Kanagawa Dental University
Division name
Division of Environmental Pathology, Department of Oral Science
Zip code
238-8580
Address
82 Inaoka-cho, Yokosuka-shi, Kanagawa, Japan
TEL
046-822-1500
Homepage URL
tsukinoki@kdu.ac.jp
Sponsor or person
Institute
Kanagawa Dental University
Institute
Department
Personal name
Funding Source
Organization
EPS holdings Inc.
Organization
Division
Category of Funding Organization
Profit organization
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-shi, Kanagawa, Japan
Tel
046-822-1500
graduate@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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 04 | Month | 01 | 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
200
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
| 2021 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 06 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 26 | 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
From April 6, 2021, it will be implemented for subjects who have been recruited in hospitals or via the Internet. SARS-CoV2 S protein-specific immunoglobulin levels in blood and saliva will be measured to examine their association with COVID-19 infection.
Management information
Registered date
| 2021 | Year | 03 | Month | 23 | Day |
Last modified on
| 2022 | Year | 01 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049910
