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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040694
Receipt No. R000046448
Scientific Title SUrveillance of SARS-CoV-2 Virus Antibody in Health CarE and CloSe-Contact WorkerS
Date of disclosure of the study information 2020/06/09
Last modified on 2020/06/09

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Basic information
Public title SUrveillance of SARS-CoV-2 Virus Antibody in Health CarE and CloSe-Contact WorkerS
Acronym SUCCESS
Scientific Title SUrveillance of SARS-CoV-2 Virus Antibody in Health CarE and CloSe-Contact WorkerS
Scientific Title:Acronym SUCCESS
Region
Japan

Condition
Condition Coronavirus disease-19
Classification by specialty
Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Assessment of COVID 19 antibody positivity in health-care professions and workers
Basic objectives2 Others
Basic objectives -Others none
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes We examine the distribution of antibody positivity against COVID-19 among health-care professions and workplace workers at high risk of infection, using either the POC test kit or the laboratory test.
Key secondary outcomes none

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 Prevention
Type of intervention
Other
Interventions/Control_1 Both COVID-19 antibody POC test kit and the laboratory test are not approved, and therefor this study is intervention research.
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 1)adult more than 20 years-old
2)health-care professions
3)workers who have many opportunities to interact with peoples(sales, face-to-face work sites, and crowded works)
Key exclusion criteria 1)persons under 20
2) persons who did not get consent
3) persons who are judged to be inappropriate for inclusion in the study by the principal investigator / partner and the medical staff involved in the study
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name Masakatsu
Middle name
Last name Nishikawa
Organization Kinki Health Administration Center (KKC)
Division name Mie Health Checkup Clinic
Zip code 514-0131
Address 4-1-3 Anotsudai, Tsu, Mie 514-0131, JAPAN
TEL 059-253-7426
Email nishikawa17635@gmail.com

Public contact
Name of contact person
1st name Masakatsu
Middle name
Last name Nishikawa
Organization Kinki Health Administration Center (KKC)
Division name Mie Health Checkup Clinic
Zip code 514-0131
Address 4-1-3 Anotsudai, Tsu, Mie 514-0131, JAPAN
TEL 0592537426
Homepage URL
Email nishikawa17635@gmail.com

Sponsor
Institute Kinki Health Administration Center,
Mie Health Checkup Clinic
Institute
Department

Funding Source
Organization Kinki Health Administration Center
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 Central Research Ethic Committee, Kinki Health Administration Center
Address 10-10 Kinoshita-cho, Ootsu, Shiga 520-0812, JAPAN
Tel 077-525-5418
Email t_hachio@zai-kkc.or.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
2020 Year 06 Month 09 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 05 Month 21 Day
Date of IRB
2020 Year 05 Month 26 Day
Anticipated trial start date
2020 Year 06 Month 10 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
2021 Year 05 Month 31 Day
Date trial data considered complete
2021 Year 07 Month 31 Day
Date analysis concluded
2021 Year 09 Month 30 Day

Other
Other related information

Management information
Registered date
2020 Year 06 Month 09 Day
Last modified on
2020 Year 06 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046448

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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