UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043538 |
|---|---|
| Receipt number | R000049716 |
| Scientific Title | Survey on prevalence of SARS-CoV-2 infection in health care workers, working at large-scale medical institutions |
| Date of disclosure of the study information | 2021/03/06 |
| Last modified on | 2022/05/19 19:38:22 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Survey on prevalence of SARS-CoV-2 infection in health care workers, working at large-scale medical institutions
Acronym
Survey on prevalence of SARS-CoV-2 infection in health care workers, working at large-scale medical institutions
Scientific Title
Survey on prevalence of SARS-CoV-2 infection in health care workers, working at large-scale medical institutions
Scientific Title:Acronym
Survey on prevalence of SARS-CoV-2 infection in health care workers, working at large-scale medical institutions
Region
| Japan |
Condition
Condition
Coronavirus Disease-2019(COVID-19, SARS-CoV-2 infection)
Classification by specialty
| Pneumology | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aimed to investigate the seroprevalence against SARS-CoV-2 in healthcare workers working at medical institutions for obtaining knowledge on maintaining the medical care provision system under the spread of SARS-CoV-2 infection.
Basic objectives2
Others
Basic objectives -Others
Evaluating the time course of various immune responses before and after vaccination.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Seroprevalence against SARS-CoV-2 in healthcare workers working at medical institutions
Key secondary outcomes
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
Those who meet all of the following criteria.
[Part 1]
(1) Those who are 20 years of age or older at the time of registration.
(2) Those who have worked at the medical institution for at least one month within the past year from the time of registration.
[Part 2]
(1) Those who are scheduled to be vaccinated against SARS-CoV-2 within 3 months from the time of study registration
Key exclusion criteria
Those who meet the following criteria are excluded.
[Part 1]
(1) Those who specimen of previous vaccination against SARS-CoV-2 is not available.
(2) Those who with mental illness or other conditions that might affect their ability to consent
(3) Those who are deemed by the researcher to be unsuitable to participate in the research.
[Part 2]
(1) Those who plan to retire from the medical institution during the follow-up survey at the time of obtaining consent.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Hideaki |
| Middle name | |
| Last name | Kato |
Organization
Yokohama City University Hospital
Division name
Infection Control Unit
Zip code
236-0004
Address
3-9 Fukuura, kanazawa-ku, Yokohama 2360004, Japan
TEL
045-787-2800
ekato@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Hieaki |
| Middle name | |
| Last name | Kato |
Organization
Yokohama City University Hospital
Division name
Infection Control Unit
Zip code
236-0004
Address
3-9 Fukuura, kanazawa-ku, Yokohama 2360004, Japan
TEL
045-787-2800
Homepage URL
ekato@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yokohama City University Hospital
Address
3-9 Fukuura, kanazawa-ku, Yokohama 2360004, Japan
Tel
045-370-7627
rinri@yokohama-cu.ac.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
| 2021 | Year | 03 | Month | 06 | 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
Completed
Date of protocol fixation
| 2021 | Year | 02 | Month | 25 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 04 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 08 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a prospective observational study of healthcare workers.
Management information
Registered date
| 2021 | Year | 03 | Month | 05 | Day |
Last modified on
| 2022 | Year | 05 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049716
