UMIN-CTR Clinical Trial

Basic information
Public title	A multicenter seroepidemiological study of SARS-CoV-2 antibody prevalence in oral surgery medical staff.
Acronym	A multicenter seroepidemiological study of SARS-CoV-2 antibody prevalence in oral surgery medical staff.
Scientific Title	A multicenter seroepidemiological study of SARS-CoV-2 antibody prevalence in oral surgery medical staff.
Scientific Title:Acronym	A multicenter seroepidemiological study of SARS-CoV-2 antibody prevalence in oral surgery medical staff.
Region	Japan

Condition
Condition	COVID-19
Classification by specialty	Oral surgery Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We explore the prevalence of antibodies against SARS-CoV-2 in oral surgery medical staff at multiple centers.
Basic objectives2	Others
Basic objectives -Others	We establish evidence-based infection precaution protocols for COVID-19 by level.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	the SARS-CoV-2 antibody prevalence in oral surgery medical staff
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
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Maneuver
Interventions/Control_1	Blood sampling (5 ml) will be performed once during the study period.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Persons who are employees in the field of oral surgery (dentists, dental hygienists, nurses, dental technicians) and who have obtained the consent of the document by their own free will after fully understanding when participating in this study.
Key exclusion criteria	Persons who are judged to be ineligible for this study by the principal investigator.
Target sample size	300

Research contact person
Name of lead principal investigator	1st name Yoko Middle name Last name Koga
Organization	Tokyo Women's Medical University, School of Medicine
Division name	Department of Oral and Maxillofacial Surgery
Zip code	162-8666
Address	8-1 Kawada-cho, Shinjuku-ku, Tokyo
TEL	03-3353-8111
Email	koga.yoko@twmu.ac.jp

Public contact
Name of contact person	1st name Yoko Middle name Last name Koga
Organization	Tokyo Women's Medical University, School of Medicine
Division name	Department of Oral and Maxillofacial Surgery
Zip code	162-8666
Address	8-1 Kawada-cho, Shinjuku-ku, Tokyo
TEL	03-3353-8111
Homepage URL
Email	koga.yoko@twmu.ac.jp

Sponsor
Institute	Tokyo Women's Medical University, School of Medicine
Institute
Department

Funding Source
Organization	sysmex Corporation
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Tokyo Women's Medical University, School of Medicine
Address	8-1 Kawada-cho, Shinjuku-ku, Tokyo
Tel	03-3353-8111
Email	koga.yoko@twmu.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 03 Month 30 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	Enrolling by invitation
Date of protocol fixation	2020 Year 12 Month 03 Day
Date of IRB	2020 Year 12 Month 03 Day
Anticipated trial start date	2021 Year 02 Month 10 Day
Last follow-up date	2021 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 03 Month 30 Day
Last modified on	2021 Year 03 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049983