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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000044225
Receipt No. R000050509
Scientific Title Evaluation of rapid diagnostic test for SARS-CoV-2 infection
Date of disclosure of the study information 2021/06/30
Last modified on 2021/05/17

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Basic information
Public title Evaluation of assay kit for detecting SARS-CoV-2 infection
Acronym Evaluation of assay kit for detecting SARS-CoV-2 infection
Scientific Title Evaluation of rapid diagnostic test for SARS-CoV-2 infection
Scientific Title:Acronym Evaluation of rapid diagnostic test for SARS-CoV-2 infection
Region
Japan

Condition
Condition Coronavirus disease 2019
Classification by specialty
Infectious disease Pediatrics Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of rapid diagnostic test for SARS-CoV-2 infection
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Sensitivity, specificity and detection limit of rapid diagnostic test for SARS-CoV-2 infection
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Maneuver Other
Interventions/Control_1 Sample collection, assay with test kit
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 that visit the medical institution during this study, and include the following conditions:
1) Patients with suspected SARS-CoV-2 infection based on symptoms.
2) Patients who agree to participate in this study.
Key exclusion criteria 1) Patients who are difficult to obtain clinical samples from.
2) For any reason other than above, patients who were determined by doctor as being unfit to participate in this study.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Daisuke
Middle name
Last name Tamura
Organization Jichi Medical University Hospital
Division name Paediatrics
Zip code 239-0498
Address 3311-1 Yakushiji, Shimono-shi, Tochigi, 329-0498, Japan
TEL 0285-44-2111
Email dtamura@jichi.ac.jp

Public contact
Name of contact person
1st name Yuta
Middle name
Last name Maehara
Organization Sekisui Medical Co., Ltd.
Division name Research & Development
Zip code 103-0027
Address 1-3 Nihonbashi 2-chome, Chuo-ku Tokyo 103-0027, Japan
TEL 03-3272-0677
Homepage URL
Email yuta.maehara@sekisui.com

Sponsor
Institute Sekisui Medical Co., Ltd.
Institute
Department

Funding Source
Organization Sekisui Medical Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor NA
Name of secondary funder(s)

IRB Contact (For public release)
Organization -
Address -
Tel -
Email -

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 自治医科大学(栃木県)

Other administrative information
Date of disclosure of the study information
2021 Year 06 Month 30 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 Open public recruiting
Date of protocol fixation
2020 Year 12 Month 15 Day
Date of IRB
2021 Year 01 Month 31 Day
Anticipated trial start date
2021 Year 01 Month 31 Day
Last follow-up date
2022 Year 06 Month 30 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 05 Month 17 Day
Last modified on
2021 Year 05 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050509

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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