UMIN-CTR Clinical Trial

Basic information
Public title	Survey on prevalence of SARS-CoV-2 infection in health care workers, working at large-scale medical institutions
Acronym	Survey on prevalence of SARS-CoV-2 infection in health care workers, working at large-scale medical institutions
Scientific Title	Survey on prevalence of SARS-CoV-2 infection in health care workers, working at large-scale medical institutions
Scientific Title:Acronym	Survey on prevalence of SARS-CoV-2 infection in health care workers, working at large-scale medical institutions
Region	Japan

Condition
Condition	Coronavirus Disease-2019(COVID-19, SARS-CoV-2 infection)
Classification by specialty	Pneumology Infectious disease
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We aimed to investigate the seroprevalence against SARS-CoV-2 in healthcare workers working at medical institutions for obtaining knowledge on maintaining the medical care provision system under the spread of SARS-CoV-2 infection.
Basic objectives2	Others
Basic objectives -Others	Evaluating the time course of various immune responses before and after vaccination.
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Seroprevalence against SARS-CoV-2 in healthcare workers working at medical institutions
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Those who meet all of the following criteria. [Part 1] (1) Those who are 20 years of age or older at the time of registration. (2) Those who have worked at the medical institution for at least one month within the past year from the time of registration. [Part 2] (1) Those who are scheduled to be vaccinated against SARS-CoV-2 within 3 months from the time of study registration
Key exclusion criteria	Those who meet the following criteria are excluded. [Part 1] (1) Those who specimen of previous vaccination against SARS-CoV-2 is not available. (2) Those who with mental illness or other conditions that might affect their ability to consent (3) Those who are deemed by the researcher to be unsuitable to participate in the research. [Part 2] (1) Those who plan to retire from the medical institution during the follow-up survey at the time of obtaining consent.
Target sample size	500

Research contact person
Name of lead principal investigator	1st name Hideaki Middle name Last name Kato
Organization	Yokohama City University Hospital
Division name	Infection Control Unit
Zip code	236-0004
Address	3-9 Fukuura, kanazawa-ku, Yokohama 2360004, Japan
TEL	045-787-2800
Email	ekato@yokohama-cu.ac.jp

Public contact
Name of contact person	1st name Hieaki Middle name Last name Kato
Organization	Yokohama City University Hospital
Division name	Infection Control Unit
Zip code	236-0004
Address	3-9 Fukuura, kanazawa-ku, Yokohama 2360004, Japan
TEL	045-787-2800
Homepage URL
Email	ekato@yokohama-cu.ac.jp

Sponsor
Institute	Yokohama City University
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Yokohama City University Hospital
Address	3-9 Fukuura, kanazawa-ku, Yokohama 2360004, Japan
Tel	045-370-7627
Email	rinri@yokohama-cu.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 06 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	Completed
Date of protocol fixation	2021 Year 02 Month 25 Day
Date of IRB	2021 Year 03 Month 04 Day
Anticipated trial start date	2021 Year 03 Month 08 Day
Last follow-up date	2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	This study is a prospective observational study of healthcare workers.

Management information
Registered date	2021 Year 03 Month 05 Day
Last modified on	2022 Year 05 Month 19 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049716