UMIN-CTR Clinical Trial

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	https://www.ijidonline.com/article/S1201-9712(22)00517-3/fulltext
Publication of results	Published

Result
URL related to results and publications	https://www.ijidonline.com/article/S1201-9712(22)00517-3/fulltext
Number of participants that the trial has enrolled	16
Results	See https://www.ijidonline.com/article/S1201-9712(22)00517-3/fulltext
Results date posted	2022 Year 11 Month 16 Day
Results Delayed
Results Delay Reason	not applicable
Date of the first journal publication of results	2022 Year 11 Month 01 Day
Baseline Characteristics	See https://www.ijidonline.com/article/S1201-9712(22)00517-3/fulltext
Participant flow	See https://www.ijidonline.com/article/S1201-9712(22)00517-3/fulltext
Adverse events	not applicable
Outcome measures	See https://www.ijidonline.com/article/S1201-9712(22)00517-3/fulltext
Plan to share IPD	not applicable
IPD sharing Plan description	not applicable

Progress
Recruitment status	Completed
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	2022 Year 11 Month 16 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050509