UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040694 |
|---|---|
| Receipt number | 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 08:55:45 |
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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
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
nishikawa17635@gmail.com
Sponsor or person
Institute
Kinki Health Administration Center,
Mie Health Checkup Clinic
Institute
Department
Personal name
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
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
Value
https://center6.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 |
