UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049018 |
|---|---|
| Receipt number | R000055848 |
| Scientific Title | GLOBAL STUDY ON THE CLINICAL DETECTION PERFORMANCE AND USEFULNESS OF NOVEL CORONAVIRUS RAPID DIAGNOSIS KIT |
| Date of disclosure of the study information | 2022/09/27 |
| Last modified on | 2023/03/28 18:11:31 |
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Basic information
Public title
GLOBAL STUDY ON THE CLINICAL DETECTION PERFORMANCE AND USEFULNESS OF NOVEL CORONAVIRUS RAPID DIAGNOSIS KIT
Acronym
GLOBAL STUDY ON THE CLINICAL DETECTION PERFORMANCE AND USEFULNESS OF NOVEL CORONAVIRUS RAPID DIAGNOSIS KIT
Scientific Title
GLOBAL STUDY ON THE CLINICAL DETECTION PERFORMANCE AND USEFULNESS OF NOVEL CORONAVIRUS RAPID DIAGNOSIS KIT
Scientific Title:Acronym
GLOBAL STUDY ON THE CLINICAL DETECTION PERFORMANCE AND USEFULNESS OF NOVEL CORONAVIRUS RAPID DIAGNOSIS KIT
Region
| Asia(except Japan) |
Condition
Condition
SARS-CoV-2
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Primary objective: To verify the detection performance of the Rapid Antigen Test by comparing with RT-PCR test in determining SARS-CoV-2 virus
Basic objectives2
Others
Basic objectives -Others
Secondary objective: To verify the detection performance of the Rapid Antigen Test in specimens collected over time and in different types of specimen from SARS-CoV-2 positive patients.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary endpoint: The agreement rate between the test results of RT-PCR test and the Rapid Antigen Test.
Key secondary outcomes
Secondary endpoint: The agreement rate between the Rapid Antigen Test and RT-PCR test in specimens collected at different times after onset and the agreement rate of test results in two different types of specimen.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 7 | years-old | < |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) For compliance on the ethical aspects of the study, only individuals who willingly and voluntarily participate are selected. In addition, the wide range of age population is sufficient to address the objectives of the study.
(2) Based on the presumption that seven years old is the minimum age that can comprehend any explanation about the study
(3) The Rapid Antigen Test in this study is designed to detect SARS-CoV-2 virus which can be useful in the diagnosis of the infection
Key exclusion criteria
(1) Swab specimens is difficult to collect from individuals who use illegal drugs due to a possible nasal mucosal injury.
(2) Detection of virus may be difficult to collect if symptoms have elapsed 5 days from the onset
(3) Any incompatible factors may affect the study
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Norio |
| Middle name | |
| Last name | Ohmagari |
Organization
National Center for Global Health and Medicine
Division name
Disease Control and Prevention Center
Zip code
162-8655
Address
1-21-1, Toyama, Shinjuku-ku, Tokyo, Japan
TEL
03-6228-0445
nohmagari@hosp.ncgm.go.jp
Public contact
Name of contact person
| 1st name | Maria Ruriko |
| Middle name | |
| Last name | Umano |
Organization
National Center for Global Health and Medicine
Division name
Department of International Trials
Zip code
162-8655
Address
1-21-1, Toyama, Shinjuku-ku, Tokyo, Japan
TEL
03-6228-0445
Homepage URL
mumano@hosp.ncgm.go.jp
Sponsor or person
Institute
National Center for Global Health and Medicine
Institute
Department
Personal name
Funding Source
Organization
AMED
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
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, Japan
Tel
03-6228-0445
takobayashi@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
| 2022 | Year | 09 | Month | 27 | 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
655
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
Completed
Date of protocol fixation
| 2021 | Year | 11 | Month | 02 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 25 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 31 | Day |
Last follow-up date
| 2022 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 11 | Month | 30 | Day |
Date analysis concluded
| 2023 | Year | 01 | Month | 31 | Day |
Other
Other related information
N/A
Management information
Registered date
| 2022 | Year | 09 | Month | 26 | Day |
Last modified on
| 2023 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055848
