UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044648 |
|---|---|
| Receipt number | R000050926 |
| Scientific Title | Epidemiological Research on SARS-CoV-2 (novel coronavirus) Antibody Positivity Rate among Healthcare Workers at Saitama Medical Center, Jichi Medical University during the COVID-19 Pandemic |
| Date of disclosure of the study information | 2021/06/30 |
| Last modified on | 2021/06/24 21:13:59 |
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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 during the COVID-19 Pandemic
Acronym
Epidemiological Research on SARS-CoV-2 Antibody Positivity Rate among Healthcare Workers
Scientific Title
Epidemiological Research on SARS-CoV-2 (novel coronavirus) Antibody Positivity Rate among Healthcare Workers at Saitama Medical Center, Jichi Medical University during the COVID-19 Pandemic
Scientific Title:Acronym
Epidemiological Research on SARS-CoV-2 Antibody Positivity Rate among Healthcare Workers
Region
| Japan |
Condition
Condition
COVID-19
Classification by specialty
| Medicine in general | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the prevalence of SARS-COV-2 antibodies among healthcare workers at our center.
To clarify the characteristics of SARS-COV-2 antibody-positive patients.
Basic objectives2
Others
Basic objectives -Others
Prevalence measurement
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary outcome is the rate of antibody positivity in the entire research population, and the change in the rate of positivity
Key secondary outcomes
The secondary outcome is the detection of significant differences in each factor among antibody-positive and antibody-negative subjects (age, sex, place of residence, department, the presence of COVID19 in the patient in charge if not an early resident, travel history in the past year, access to cluster-infected areas, the presence of cold symptoms and fever within 3 months), and subsequent incidence of COVID-19 in antibody-positive individuals.
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 including junior resident, physicians in general medicine department, physicians in emergency department, physicians ICU, EICU nurses, emergency and ward 2A nurses who have given consent for this research, who have been or will be engaged in the treatment of SARS-COV-2 infected patients
Key exclusion criteria
Those with fever, cough, or respiratory distress at the time of the initial examination, and those who do not consent to the research.
Target sample size
60
Research contact person
Name of lead principal investigator
| 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
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
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
116
Results
All tests performed during the research period were negative for SARS-CoV2 antibody
Results date posted
| 2021 | Year | 06 | Month | 18 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
38 doctors and 78 nurses participated.
There were 116 participants in the cohort study, with a median age of 29 years, of whom 75.9% were female.
Participant flow
Of the 116 participants in the cohort study, 111, 103, and 107 underwent blood sampling in May, June, and July, respectively.
Adverse events
None
Outcome measures
All participants in the cohort study tested negative for antibodies in the first, second, and third tests
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 | 10 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2021 | Year | 06 | Month | 18 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Participants were measured monthly anti-SARS-CoV2 antibody for 3 months.
A structured questionnaire was administered whenever blood was drawn for antibody testing, to assess adherence to infection prevention measures, including thorough hand hygiene and avoidance of unnecessary and nonurgent outings and situations with a high risk of contracting the infection.
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=R000050926
