UMIN-CTR Clinical Trial

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