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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043400
Receipt No. R000049552
Scientific Title Evaluation of operational capacity of mobile "street laboratory": a pilot study using PCR test and antibody test for COVID-19
Date of disclosure of the study information 2021/02/21
Last modified on 2021/02/21

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Basic information
Public title Evaluation of operational capacity of mobile "street laboratory": a pilot study using PCR test and antibody test for COVID-19
Acronym Evaluation of operational capacity of mobile "street laboratory": a pilot study using PCR test and antibody test for COVID-19
Scientific Title Evaluation of operational capacity of mobile "street laboratory": a pilot study using PCR test and antibody test for COVID-19
Scientific Title:Acronym Evaluation of operational capacity of mobile "street laboratory": a pilot study using PCR test and antibody test for COVID-19
Region
Japan

Condition
Condition COVID-19
Classification by specialty
Infectious disease Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to evaluate the operational capacity of mobile "street laboratory" using medical containers or trailers. As a pilot study, a set of PCR and antibody tests for SARS-CoV-2 will be conducted in healthy adults to examine the maximum number of tests that can be performed per day.
Basic objectives2 Others
Basic objectives -Others Based on these test results, PCR positive rate and antibody positive rate in healthy adults will be clarified.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Operational capacity of mobile "street laboratory"
Key secondary outcomes Distribution of PCR positive rate and antibody titer for SARS-CoV-2 in healthy adults

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 The Ethical Committee determined that restricting the behavior of study subjects may correspond to an intervention depending on the results of PCR tests.
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 - Persons who are faculty members or students of Osaka City University or Osaka Prefecture University as of the date of participation in this study (i.e., the date of sampling)

- Persons who are employees of Osaka City or Osaka Prefecture as of the date of participation in this study (i.e., the date of sampling)
Key exclusion criteria - Persons who are not allowed to attend work on the day of participation in this study (i.e., the date of sampling) due to the rules or standards of the institution to which they belong
Target sample size 2400

Research contact person
Name of lead principal investigator
1st name Hiroshi
Middle name
Last name Kayeka
Organization Osaka City University Graduate School of Medicine
Division name Department of Infection Control Science
Zip code 545-8585
Address 1-4-3, Asahi-machi, Abeno-ku, Osaka, Japan
TEL 06-6645-3784
Email kakeya@med.osaka-cu.ac.jp

Public contact
Name of contact person
1st name Hiroshi
Middle name
Last name Kayeka
Organization Osaka City University Graduate School of Medicine
Division name Department of Infection Control Science
Zip code 545-8585
Address 1-4-3, Asahi-machi, Abeno-ku, Osaka, Japan
TEL 06-6645-3784
Homepage URL
Email kakeya@med.osaka-cu.ac.jp

Sponsor
Institute Osaka City University
Institute
Department

Funding Source
Organization Osaka City University
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 Ethical Committee of Osaka City University Graduate School of Medicine
Address Abeno Medix 6F, 1-2-7, Asahi-machi, Abeno-ku, Osaka, Japan
Tel 06-6645-3456
Email ethics@med.osaka-cu.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 02 Month 21 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 Preinitiation
Date of protocol fixation
2020 Year 10 Month 02 Day
Date of IRB
2020 Year 10 Month 02 Day
Anticipated trial start date
2021 Year 06 Month 01 Day
Last follow-up date
2022 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 02 Month 21 Day
Last modified on
2021 Year 02 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049552

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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