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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000044177
Receipt No. R000050450
Scientific Title A study of nasal sampling for SARS-COV-2 and influenza antigen testing
Date of disclosure of the study information 2021/05/11
Last modified on 2021/05/11

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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
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 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
2023 Year 02 Month 28 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 11 Day
Last modified on
2021 Year 05 Month 11 Day


Link to view the page
URL(English) https://upload.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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