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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000044648
Receipt No. 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

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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
Email 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
Email hsmdfacp@jichi.ac.jp

Sponsor
Institute Saitama Medical Center Jichi Medical University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050926

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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