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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000040333
Receipt No. R000046025
Scientific Title Fact-finding survey on subclinical infection of SARS-CoV-2 in Kanagawa Prefecture
Date of disclosure of the study information 2020/05/08
Last modified on 2020/07/17

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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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