UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040453 |
|---|---|
| Receipt number | R000046159 |
| Scientific Title | Long-term follow-up of corona virus disease 2019 (COVID-19) antibody seroprevalence in the cohort of employees at hospitals with or without cluster of COVID-19. |
| Date of disclosure of the study information | 2020/05/25 |
| Last modified on | 2023/05/22 14:39:38 |
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Basic information
Public title
Corona virus disease 2019 (COVID-19) antibody seroprevalence of the medical staff in the hospital with cluster of COVID-19.
Acronym
COVID-19 antibody seroprevalence of medical staff in the hospital with cluster of COVID-19.
Scientific Title
Long-term follow-up of corona virus disease 2019 (COVID-19) antibody seroprevalence in the cohort of employees at hospitals with or without cluster of COVID-19.
Scientific Title:Acronym
Long-term follow-up of COVID-19 antibody seroprevalence in the cohort of medical staff.
Region
| Japan |
Condition
Condition
COVID-19
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to provide a more complete estimation of COVID-19 in hospital with or without COVID-19 cluster by seroprevalence survey of COVID-19.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Total number of COVID-19, including those infections that might have been missed (include asymptomatic cases)
Key secondary outcomes
Incidence of seroconversion in high-risk population (working in hospital with cluster, job, and exposure to COVID-19).
Timeline of seroconversion.
Development of herd immunity.
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
Employee of Osaka Police Hospital and Daini Osaka Police Hospital at May 2020.
Person who received regular medical checkup.
Key exclusion criteria
Person who don't want to participate the study
Target sample size
2500
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Ogata |
Organization
Daini Osaka Police Hospital
Division name
Departmrny of Internal Medeicine
Zip code
543-8922
Address
2-6-40, Karasugatsuji, Tennoji-ku Osaka, Japan
TEL
06-6773-7111
a24ogata@icloud.com
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Ogata |
Organization
Daini Osaka Police Hospital
Division name
Departmrny of Internal Medeicine
Zip code
543-8922
Address
2-6-40, Karasugatsuji, Tennoji-ku Osaka, Japan
TEL
06-6773-7111
Homepage URL
a24ogata@icloud.com
Sponsor or person
Institute
Daini Osaka Police Hospital
Institute
Department
Personal name
Funding Source
Organization
Daini Osaka Police Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Osaka Police Hospital
Department of Clinical Immunology, Graduate School of Medicine, Osaka University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Daini Osaka Police Hospital
Address
2-6-40, Karasugatsuji, Tennoji-ku Osaka, Japan
Tel
06-6773-7050
m-kubota@oph.gr.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 | 05 | Month | 25 | 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
45
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
| 2020 | Year | 05 | Month | 15 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 18 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 25 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
COVID-19 antibody will be measured by Elecsys Anti-SARS-CoV-2 (Roche) at regular medical checkup (May 2020, Nov 2020, May 2021, Nov 2021). Exposure to COVID-19, noticeable symptoms which may be related to COVID-19 infection will be collected with each regular medical checkup. Other corona virus antibody will be analyzed.
Management information
Registered date
| 2020 | Year | 05 | Month | 19 | Day |
Last modified on
| 2023 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046159
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
