UMIN-CTR Clinical Trial

Basic information
Public title	Epidemiological Research on SARS-CoV-2 (novel coronavirus) Antibody Positivity Rate among Healthcare Workers at Saitama Medical Center, Jichi Medical University
Acronym	Epidemiological Research on SARS-CoV-2 Antibody Positivity Rate among Healthcare Workers at Saitama Medical Center, Jichi Medical University
Scientific Title	Epidemiological Research on SARS-CoV-2 (novel coronavirus) Antibody Positivity Rate among Healthcare Workers at Saitama Medical Center, Jichi Medical University
Scientific Title:Acronym	Epidemiological Research on SARS-CoV-2 Antibody Positivity Rate among Healthcare Workers at Saitama Medical Center, Jichi Medical University
Region	Japan

Condition
Condition	COVID-19
Classification by specialty	Medicine in general Infectious disease Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To verify the effectiveness of infection control measures by clarifying the prevalence of SARS-COV-2 antibodies among healthcare workers at our center
Basic objectives2	Others
Basic objectives -Others	To clarify the characteristics of SARS-COV-2 antibody-positive healthcare workers at our center
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The primary outcome is the difference between the antibody-positive rate among all research subjects and the rate among COVID-19 practitioners
Key secondary outcomes	The secondary outcome is the detection of significant differences in each factor between antibody-positive and antibody-negative subjects (Age, gender, place of residence, department, presence of COVID19 in the patient in charge, travel history in the last year, access to cluster-infected areas, the common cold symptoms and fever within 4 months)

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Healthy medical personnel who are engaged in this hospital and who have given consent to this research
Key exclusion criteria	Those with symptoms of COVID-19 within 2 weeks of the test, and those who do not consent to the research
Target sample size	400

Research contact person
Name of lead principal investigator	1st name Hitoshi Middle name Last name Sugawara
Organization	Saitama Medical Center, Jichi Medical Univers ity
Division name	General Medicine
Zip code	3308503
Address	1-847 Amanuma-chou, Omiya-ku, Saitama city, Saitama, Japan
TEL	0486472111
Email	hsmdfacp@jichi.ac.jp

Public contact
Name of contact person	1st name Hitoshi Middle name Last name Sugawara
Organization	Saitama Medical Center, Jichi Medical University
Division name	General Medicine
Zip code	3308503
Address	1-847 Amanuma-chou, Omiya-ku, Saitama city, Saitama, Japan
TEL	0486472111
Homepage URL
Email	hsmdfacp@jichi.ac.jp

Sponsor
Institute	Saitama Medical Center, Jichi Medical University
Institute
Department

Funding Source
Organization	Daiichi Sankyo Research Support Program 2020 (Grant Number: A20-1249)
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Jichi Medical University Bioethics Committee for Clinical Research, Saitama Medical Center
Address	1-847 Amanuma-cho, Omiya-ku, Saitama city, Saitama
Tel	0486472111
Email	s-suishin@jichi.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	自治医大附属さいたま医療センター

Other administrative information
Date of disclosure of the study information	2021 Year 06 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	607
Results	Only one participant tested positive for anti SARS CoV 2 antibody, with a seroprevalence of 0.16% (95% CI 0.008 1.06%).
Results date posted	2021 Year 06 Month 24 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	There were 607 participants in the study, with a median age was 34 years, of whom 69.4% were female. The proportion of participants engaged in COVID-19-related medical care was 26.7%.
Participant flow
Adverse events	None
Outcome measures	Multivariate analysis showed no difference in the antibody-positive rate between persons who engaged in COVID-19-related medical care and those who did not in the study. No significant differences were noted in antibody seroprevalence according to smoking history, occupation, symptoms suggestive of COVID-19 within the previous 4 months, travel history, municipality of residence, or use of public transportation to commute.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2020 Year 05 Month 01 Day
Date of IRB	2020 Year 06 Month 29 Day
Anticipated trial start date	2020 Year 05 Month 01 Day
Last follow-up date	2021 Year 02 Month 09 Day
Date of closure to data entry	2021 Year 06 Month 24 Day
Date trial data considered complete	2021 Year 06 Month 24 Day
Date analysis concluded	2021 Year 06 Month 24 Day

Other

Other related information

Following items as at the time of the research shall be recorded in the questionnaire: The subject's age, sex, city of residence, the presence or absence of underlying illness, smoking history, department of employment, history of BCG intake, the presence or absence of COVID19 (novel coronavirus infection) in the patient and its timing, travel history in the last year, the presence or absence of access to cluster-infected areas (location, date and time), the presence or absence of the common cold symptoms (cough, nasal discharge, sore throat, malaise, dysgeusia, fever) within 4 months and its date (how many days before the test), the presence or absence of fever and date (days before the test), and the presence of fever Analyze whether there are statistically significant differences in the proportions of these factors among the subjects who test positive for antibodies compared to the subjects who test negative

Management information
Registered date	2021 Year 06 Month 24 Day
Last modified on	2021 Year 06 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050986