UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049723 |
|---|---|
| Receipt number | R000056582 |
| Scientific Title | Clinical Performance Study of "COVID-19 Ag Rapid Saliva Test Device" |
| Date of disclosure of the study information | 2022/12/19 |
| Last modified on | 2023/06/08 11:48:11 |
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Basic information
Public title
Clinical Performance Verification Study of "COVID-19 Ag Rapid Saliva Test Device" for Diagnostic Aid of SARS-CoV-2 Infection
Acronym
Clinical Performance Study of "COVID-19 Ag Rapid Saliva Test Device"
Scientific Title
Clinical Performance Study of "COVID-19 Ag Rapid Saliva Test Device"
Scientific Title:Acronym
Clinical Performance Study of "COVID-19 Ag Rapid Saliva Test Device"
Region
| Japan |
Condition
Condition
COVID-19
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the clinical performance of the product (In vitro diagnostic reagent) by the comparison study with real-time RT-PCR recommended by National Institute of Infectious Disease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Positive percent agreement, Negative percent agreement and Overall percent agreement are all not lower than 90 percent.
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with symptoms include fever (37.5 degrees C or higher) or sore throat and cough who are suspected of having the COVID-19, or may be infected.
Key exclusion criteria
Patients with symptoms for more than ten days.
Patients with an invalid test result.
Patients who could not collect saliva needed for testing.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Yasunari |
| Middle name | |
| Last name | Sakamoto |
Organization
Tokyo Heart Center
Division name
Cardiovascular internal medicine
Zip code
141-0001
Address
5-4-12, Kitashinagawa, Shinagawa-ku, Tokyo, Japan
TEL
03-5789-8100
ysakamoto@tokyoheart.or.jp
Public contact
Name of contact person
| 1st name | Kenji |
| Middle name | |
| Last name | Kobayashi |
Organization
Tokyo Heart Center
Division name
Pharmaceutical Dep. / Medical Technology Dep.
Zip code
141-0001
Address
5-4-12, Kitashinagawa, Shinagawa-ku, Tokyo, Japan
TEL
03-5789-8100
Homepage URL
pkobayashi@tokyoheart.or.jp
Sponsor or person
Institute
BIC GROUP Ltd.
Institute
Department
Personal name
Funding Source
Organization
BIC GROUP Ltd.
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
Tokyo Heart Center Ethical Review Board
Address
5-4-12, Kitashinagawa, Shinagawa-ku, Tokyo, Japan
Tel
03-5789-8100
pkobayashi@tokyoheart.or.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
CR2022-01
Org. issuing International ID_1
Tokyo Heart Center Ethical Review Board
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 | 12 | Month | 19 | 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
Terminated
Date of protocol fixation
| 2022 | Year | 10 | Month | 28 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 07 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 12 | Day |
Last follow-up date
| 2023 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
age, sex, symptoms, date of onset
Management information
Registered date
| 2022 | Year | 12 | Month | 08 | Day |
Last modified on
| 2023 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056582
