UMIN-CTR Clinical Trial

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