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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000041262
Receipt No. R000047120
Scientific Title Observational study of SARS-CoV-2 antibody test positive rate.
Date of disclosure of the study information 2020/08/01
Last modified on 2020/08/01

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Basic information
Public title Observational study of SARS-CoV-2 antibody test positive rate.
Acronym Observational study of SARS-CoV-2 antibody test positive rate.
Scientific Title Observational study of SARS-CoV-2 antibody test positive rate.
Scientific Title:Acronym Observational study of SARS-CoV-2 antibody test positive rate.
Region
Japan

Condition
Condition SARS-CoV-2
Classification by specialty
Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Conduct a SARS-CoV-2 antibody test and calculate the test positive rate.
Examine the influence of volunteers' factors on the test positive rate
Basic objectives2 Others
Basic objectives -Others Epidemiological
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes SARS-CoV-2 antibody test positive rate.
Key secondary outcomes Factors that influence on test positive rate

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1, A subject, willing to take SARS-CoV-2 antibody test, gives written consent to the study.
Key exclusion criteria 1, A subject whose blood is difficult to collect.
2, A subject who the investigators think is not appropriate to the study.
Target sample size 4000

Research contact person
Name of lead principal investigator
1st name Shin
Middle name
Last name Irie
Organization SOUSEIKAI
Division name CEO
Zip code 813-0017
Address 3-5-1 Kashiiteriha, Higashi-ku, Fukuoka
TEL 0926623551
Email junko-manabe@lta-med.com

Public contact
Name of contact person
1st name Tatsuya
Middle name
Last name Yoshihara
Organization SOUSEIKAI Fukuoka Mirai Hospital
Division name Clinical Research Center
Zip code 813-0017
Address 3-5-1 Kashiiteriha, Higashi-ku, Fukuoka
TEL 0926623608
Homepage URL
Email tatsuya-yoshihara@lta-med.com

Sponsor
Institute SOUSEIKAI
Institute
Department

Funding Source
Organization SOUSEIKAI
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 Hakata Clinic Institutional Review Board
Address 6-18 Tenyamachi, Hakata-ku, Fukuoka, Fukuoka
Tel 0922837701
Email miyako-koga@lta-med.com

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 08 Month 01 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 07 Month 21 Day
Date of IRB
2020 Year 07 Month 31 Day
Anticipated trial start date
2020 Year 08 Month 01 Day
Last follow-up date
2020 Year 10 Month 22 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Conduct a SARS-CoV-2 antibody test mainly on staff within organisation.

Management information
Registered date
2020 Year 07 Month 30 Day
Last modified on
2020 Year 08 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047120

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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