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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000042723
Receipt No. R000048652
Scientific Title Impact of nanopore platform on rapid diagnosis of COVID-19 in patients with respiratory tract infections
Date of disclosure of the study information 2020/12/11
Last modified on 2020/12/11

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Basic information
Public title Impact of nanopore platform on rapid diagnosis of COVID-19 in patients with respiratory tract infections
Acronym Impact of nanopore platform on rapid diagnosis of COVID-19 in patients with respiratory tract infections
Scientific Title Impact of nanopore platform on rapid diagnosis of COVID-19 in patients with respiratory tract infections
Scientific Title:Acronym Impact of nanopore platform on rapid diagnosis of COVID-19 in patients with respiratory tract infections
Region
Japan

Condition
Condition Patients with suspected COVID-19 or diagnosed as COVID-19
Classification by specialty
Infectious disease Emergency medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To determine whether the nanopore testing performed directly with saliva can distinguish COVID-19 from other pathogens.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Diagnostic accuracy of the nanopore testing for COVID-19 in patients with suspected COVID-19
Key secondary outcomes

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 Patients with suspected COVID-19 or diagnosed as COVID-19
Key exclusion criteria Not applicable
Target sample size 500

Research contact person
Name of lead principal investigator
1st name Tomoya
Middle name
Last name Hirose
Organization Osaka University Graduate School of Medicine
Division name Department of Traumatology and Acute Critical Medicine
Zip code 565-0871
Address 2-15 Yamada-oka, Suita, Japan
TEL 06-6879-5111
Email htomoya1979@hp-emerg.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name Jumpei
Middle name
Last name Yoshimura
Organization Osaka University Graduate School of Medicine
Division name Department of Traumatology and Acute Critical Medicine
Zip code 565-0871
Address 2-15 Yamada-oka, Suita, Japan
TEL 06-6879-5111
Homepage URL
Email jumpei.y0210@gmail.com

Sponsor
Institute Department of Traumatology and Acute Critical Medicine, Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization Department of Traumatology and Acute Critical Medicine, Osaka University Graduate School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Osaka General Medical Center
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ethical Review Board of Osaka University Hospital
Address 2-2 Yamada-oka, Suita, Japan
Tel 06-6210-8296
Email rinri@hp-crc.med.osaka-u.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 大阪大学医学部附属病院 高度救命救急センター
大阪急性期・総合医療センター 救急診療科

Other administrative information
Date of disclosure of the study information
2020 Year 12 Month 11 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 Enrolling by invitation
Date of protocol fixation
2020 Year 11 Month 27 Day
Date of IRB
2020 Year 12 Month 10 Day
Anticipated trial start date
2020 Year 12 Month 14 Day
Last follow-up date
2022 Year 12 Month 31 Day
Date of closure to data entry
2022 Year 12 Month 31 Day
Date trial data considered complete
2022 Year 12 Month 31 Day
Date analysis concluded
2022 Year 12 Month 31 Day

Other
Other related information Not applicable

Management information
Registered date
2020 Year 12 Month 11 Day
Last modified on
2020 Year 12 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048652

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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