UMIN-CTR Clinical Trial

Basic information
Public title	Fact-finding survey on subclinical infection of SARS-CoV-2 in Kanagawa Prefecture
Acronym	Fact-finding survey on subclinical infection of SARS-CoV-2 in Kanagawa Prefecture
Scientific Title	Fact-finding survey on subclinical infection of SARS-CoV-2 in Kanagawa Prefecture
Scientific Title:Acronym	Fact-finding survey on subclinical infection of SARS-CoV-2 in Kanagawa Prefecture
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 investigate the actual condition of clinical sites and analyze the subclinical infection of SARS-CoV-2, the frequency of anamnesis of infection, and the relation to backgrounds in Kanagawa.
Basic objectives2	Others
Basic objectives -Others	epidemiologic study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	SARS-CoV-2 positivity rate in IgG antibody tests
Key secondary outcomes	Rates of SARS-CoV-2-positive patients in IgG antibody tests for different elements of patient backgrounds SARS-CoV-2 positivity rate in IgG antibody tests (2,4 and 6 month after being found to be positive) Clinical symptoms (2,4 and 6 month after being found to be positive)

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patients who regularly visit medical institutions belonging to the Kanagawa Physicians Association or physicians and nurses employed at those institutions 2) All ages eligible 3) Those who are living in Japan and can participate in continuous follow-ups 4) Those who consent to participate in the study (in the case of minors, consent should be obtained from their legal guardian)
Key exclusion criteria	1) Those who have tested positive for SARS-CoV-2 2) Those who had cold-like symptoms such as a fever within the past 21 days 3) Those who had cold-like symptoms and/or a fever of 37.5 degrees or more for at least four days in 2020 4) Those who had extreme fatigue and/or dyspnea in 2020
Target sample size	1500

Research contact person
Name of lead principal investigator	1st name Ikuro Middle name Last name Matsuba
Organization	Kanagawa Physicians Association
Division name	Scientific Committee
Zip code	231-0037
Address	1-3 Fujimichou, Nakaku, Yokohama, Kanagawa
TEL	045-241-7000
Email	ikuro@matsuba-web.com

Public contact
Name of contact person	1st name Ikuro Middle name Last name Matsuba
Organization	Kanagawa Physicians Association
Division name	Scientific Committee
Zip code	231-0037
Address	1-3 Fujimichou, Nakaku, Yokohama, Kanagawa
TEL	045-241-7000
Homepage URL
Email	ikuro@matsuba-web.com

Sponsor
Institute	Kanagawa Physicians Association
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kanagawa Physicians Association Ethical Review Special Committee
Address	1-3 Fujimichou, Nakaku, Yokohama, Kanagawa
Tel	045-241-7000
Email	info@kanagawa.med.or.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	2020 Year 05 Month 08 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
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2020 Year 04 Month 18 Day
Date of IRB	2020 Year 04 Month 27 Day
Anticipated trial start date	2020 Year 05 Month 19 Day
Last follow-up date	2021 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Obtain consent from the subject and then conduct an antibody test using serum followed by a survey.

Management information
Registered date	2020 Year 05 Month 08 Day
Last modified on	2020 Year 07 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046025

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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