UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043400
Receipt number 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 2022/01/13 13:44:40

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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 or person

Institute

Osaka City University

Institute

Department

Personal name



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

Value
https://center6.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