UMIN-CTR Clinical Trial

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	0
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	Terminated
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	Reason for termination: The medical container or trailer were not able to be prepared and will not be able to be prepared in the future. In addition, importance of the study decreased given the widespread availability of COVID-19 testing in the region. The research termination report was submitted to the Institutional Review Board on August 25, 2021 and was approved on September 2, 2021.

Management information
Registered date	2021 Year 02 Month 21 Day
Last modified on	2022 Year 01 Month 13 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000049552