UMIN-CTR Clinical Trial

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
Email	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
Email	handa@kdu.ac.jp

Sponsor
Institute	Kanagawa Dental University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046461