UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044177 |
|---|---|
| Receipt number | 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 | 2022/11/11 09:54:14 |
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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
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
kyamamoto@hosp.ncgm.go.jp
Sponsor or person
Institute
National Center for Global Health and Medicine
Institute
Department
Personal name
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
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
https://doi.org/10.1016/j.jiac.2022.09.001
Publication of results
Unpublished
Result
URL related to results and publications
https://doi.org/10.1016/j.jiac.2022.09.001
Number of participants that the trial has enrolled
128
Results
https://doi.org/10.1016/j.jiac.2022.09.001
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
https://doi.org/10.1016/j.jiac.2022.09.001
Adverse events
None
Outcome measures
https://doi.org/10.1016/j.jiac.2022.09.001
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2022 | Year | 09 | Month | 08 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 05 | Month | 11 | Day |
Last modified on
| 2022 | Year | 11 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050450
