UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041402 |
|---|---|
| Receipt number | R000047146 |
| Scientific Title | Investigation for clinical utility of diagnostic reagents for COVID-19 |
| Date of disclosure of the study information | 2020/09/01 |
| Last modified on | 2020/08/13 04:51:59 |
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Basic information
Public title
Investigation for clinical utility of diagnostic reagents for COVID-19
Acronym
Investigation for clinical utility of diagnostic reagents for COVID-19
Scientific Title
Investigation for clinical utility of diagnostic reagents for COVID-19
Scientific Title:Acronym
Investigation for clinical utility of diagnostic reagents for COVID-19
Region
| Japan |
Condition
Condition
COVID-19
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the diagnostic accuracy of antigen testing compared to PCR testing
Basic objectives2
Others
Basic objectives -Others
None
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Positive and concordance rates of antigen testing compared to PCR testing
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients or health care providers who present to us as a high exposure or a suspected case of COVID-19
Key exclusion criteria
None
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Fumio |
| Middle name | |
| Last name | Otsuka |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of General Medicine
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama
TEL
086-235-7342
fumiotsu@okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Hideharu |
| Middle name | Hagiya |
| Last name | Hagiya |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of General Medicine
Zip code
2-5-1 Shikata-cho, Kita-ku, Okayama
Address
2-5-1 Shikata-cho, Kita-ku, Okayama
TEL
086-235-7342
Homepage URL
hagiya@okayama-u.ac.jp
Sponsor or person
Institute
Department of General Medicine, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
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
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee
Address
2-5-1 Shikata-cho, Kita-ku, Okayama
Tel
086-235-6938
mae6605@adm.okayama-u.ac.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
| 2020 | Year | 09 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2020 | Year | 08 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None to report
Management information
Registered date
| 2020 | Year | 08 | Month | 13 | Day |
Last modified on
| 2020 | Year | 08 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047146
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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