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

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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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name