UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044650 |
|---|---|
| Receipt number | R000050986 |
| Scientific Title | Epidemiological Research on SARS-CoV-2 (novel coronavirus) Antibody Positivity Rate among Healthcare Workers at Saitama Medical Center, Jichi Medical University |
| Date of disclosure of the study information | 2021/06/30 |
| Last modified on | 2021/06/24 21:15:28 |
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Basic information
Public title
Epidemiological Research on SARS-CoV-2 (novel coronavirus) Antibody Positivity Rate among Healthcare Workers at Saitama Medical Center, Jichi Medical University
Acronym
Epidemiological Research on SARS-CoV-2 Antibody Positivity Rate among Healthcare Workers at Saitama Medical Center, Jichi Medical University
Scientific Title
Epidemiological Research on SARS-CoV-2 (novel coronavirus) Antibody Positivity Rate among Healthcare Workers at Saitama Medical Center, Jichi Medical University
Scientific Title:Acronym
Epidemiological Research on SARS-CoV-2 Antibody Positivity Rate among Healthcare Workers at Saitama Medical Center, Jichi Medical University
Region
| Japan |
Condition
Condition
COVID-19
Classification by specialty
| Medicine in general | Infectious disease | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effectiveness of infection control measures by clarifying the prevalence of SARS-COV-2 antibodies among healthcare workers at our center
Basic objectives2
Others
Basic objectives -Others
To clarify the characteristics of SARS-COV-2 antibody-positive healthcare workers at our center
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome is the difference between the antibody-positive rate among all research subjects and the rate among COVID-19 practitioners
Key secondary outcomes
The secondary outcome is the detection of significant differences in each factor between antibody-positive and antibody-negative subjects (Age, gender, place of residence, department, presence of COVID19 in the patient in charge, travel history in the last year, access to cluster-infected areas, the common cold symptoms and fever within 4 months)
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
Healthy medical personnel who are engaged in this hospital and who have given consent to this research
Key exclusion criteria
Those with symptoms of COVID-19 within 2 weeks of the test, and those who do not consent to the research
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Hitoshi |
| Middle name | |
| Last name | Sugawara |
Organization
Saitama Medical Center, Jichi Medical Univers
ity
Division name
General Medicine
Zip code
3308503
Address
1-847 Amanuma-chou, Omiya-ku, Saitama city, Saitama, Japan
TEL
0486472111
hsmdfacp@jichi.ac.jp
Public contact
Name of contact person
| 1st name | Hitoshi |
| Middle name | |
| Last name | Sugawara |
Organization
Saitama Medical Center, Jichi Medical University
Division name
General Medicine
Zip code
3308503
Address
1-847 Amanuma-chou, Omiya-ku, Saitama city, Saitama, Japan
TEL
0486472111
Homepage URL
hsmdfacp@jichi.ac.jp
Sponsor or person
Institute
Saitama Medical Center, Jichi Medical University
Institute
Department
Personal name
Funding Source
Organization
Daiichi Sankyo Research Support Program 2020
(Grant Number: A20-1249)
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Jichi Medical University Bioethics Committee for Clinical Research, Saitama Medical Center
Address
1-847 Amanuma-cho, Omiya-ku, Saitama city, Saitama
Tel
0486472111
s-suishin@jichi.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
自治医大附属さいたま医療センター
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 06 | Month | 30 | 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
607
Results
Only one participant tested positive for anti SARS CoV 2 antibody, with a seroprevalence of 0.16% (95% CI 0.008 1.06%).
Results date posted
| 2021 | Year | 06 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
There were 607 participants in the study, with a median age was 34 years, of whom 69.4% were female. The proportion of participants engaged in COVID-19-related medical care was 26.7%.
Participant flow
Adverse events
None
Outcome measures
Multivariate analysis showed no difference in the antibody-positive rate between persons who engaged in COVID-19-related medical care and those who did not in the study. No significant differences were noted in antibody seroprevalence according to smoking history, occupation, symptoms suggestive of COVID-19 within the previous 4 months, travel history, municipality of residence, or use of public transportation to commute.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 29 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 02 | Month | 09 | Day |
Date of closure to data entry
| 2021 | Year | 06 | Month | 24 | Day |
Date trial data considered complete
| 2021 | Year | 06 | Month | 24 | Day |
Date analysis concluded
| 2021 | Year | 06 | Month | 24 | Day |
Other
Other related information
Following items as at the time of the research shall be recorded in the questionnaire: The subject's age, sex, city of residence, the presence or absence of underlying illness, smoking history, department of employment, history of BCG intake, the presence or absence of COVID19 (novel coronavirus infection) in the patient and its timing, travel history in the last year, the presence or absence of access to cluster-infected areas (location, date and time), the presence or absence of the common cold symptoms (cough, nasal discharge, sore throat, malaise, dysgeusia, fever) within 4 months and its date (how many days before the test), the presence or absence of fever and date (days before the test), and the presence of fever
Analyze whether there are statistically significant differences in the proportions of these factors among the subjects who test positive for antibodies compared to the subjects who test negative
Management information
Registered date
| 2021 | Year | 06 | Month | 24 | Day |
Last modified on
| 2021 | Year | 06 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050986
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
