UMIN-CTR Clinical Trial

Basic information
Public title	A study of nasal sampling for SARS-COV-2 and influenza antigen testing
Acronym	A study of nasal sampling for SARS-COV-2 and influenza antigen testing
Scientific Title	A study of nasal sampling for SARS-COV-2 and influenza antigen testing
Scientific Title:Acronym	A study of nasal sampling for SARS-COV-2 and influenza antigen testing
Region	Japan

Condition
Condition	Patients with suspected COVID-19 or influenza
Classification by specialty	Medicine in general Infectious disease
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	SARS-CoV-2 antigen and influenza antigen testing of the nasal cavity will be examined for concordance with antigen testing in nasopharyngeal examination.
Basic objectives2	Others
Basic objectives -Others	Usefulness of specimen collection methods
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Evaluate the concordance between nasal Flu and nasopharyngeal antigen testing for SARS-CoV-2.
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	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Device,equipment Maneuver
Interventions/Control_1	Antigen and nucleic acid detection test for SARS-CoV-2 and influenza in nasal vestibule and nasopharyngeal swabs
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	(1) Patients who have received sufficient explanation of the purpose, methods, and significance of this study, and who can freely and voluntarily obtain written consent from themselves or their legal representative (legal guardian, legal representative). (2) Patients who are 20 years of age or older at the time of consent. (3) Patients suspected of being infected with a new coronavirus or influenza within 9 days of onset.
Key exclusion criteria	(1) Patients who have anatomical problems that make it difficult to collect nasopharyngeal swabs (2) Patients who are otherwise judged by the investigator to be ineligible for this study.
Target sample size	160

Research contact person
Name of lead principal investigator	1st name Kei Middle name Last name Yamamoto
Organization	National Center for Global Health and Medicine
Division name	Disease Control and Prevention Center
Zip code	1628655
Address	1-21-1 Toyama, Shinjuku-ku, Tokyo
TEL	03-3202-7181
Email	kyamamoto@hosp.ncgm.go.jp

Public contact
Name of contact person	1st name Kei Middle name Last name Yamamoto
Organization	National Center for Global Health and Medicine
Division name	Disease Control and Prevention Center
Zip code	1628655
Address	1-21-1 Toyama, Shinjuku-ku, Tokyo
TEL	03-3202-7181
Homepage URL
Email	kyamamoto@hosp.ncgm.go.jp

Sponsor
Institute	National Center for Global Health and Medicine
Institute
Department

Funding Source
Organization	Fujirebio, Inc.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	National Center for Global Health and Medicine
Address	1-21-1 Toyama, Shinjuku-ku, Tokyo
Tel	03-3202-7181
Email	kenkyu-shinsa@hosp.ncgm.go.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 05 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	128
Results
Results date posted	2022 Year 05 Month 12 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Symptomatic patient with suspected COVID-19
Participant flow
Adverse events	None
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2020 Year 11 Month 22 Day
Date of IRB	2020 Year 12 Month 11 Day
Anticipated trial start date	2021 Year 01 Month 21 Day
Last follow-up date	2021 Year 08 Month 24 Day
Date of closure to data entry	2021 Year 08 Month 26 Day
Date trial data considered complete	2021 Year 10 Month 20 Day
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 05 Month 11 Day
Last modified on	2022 Year 05 Month 12 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050450

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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