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

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 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

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

Value
https://center6.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