UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048796 |
|---|---|
| Receipt number | R000055606 |
| Scientific Title | Evaluation of rapid diagnostic method for SARS-CoV-2/RS virus infection |
| Date of disclosure of the study information | 2022/09/01 |
| Last modified on | 2024/03/04 14:10:50 |
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Basic information
Public title
Performance evaluation test of rapid diagnostic kit for testing SARS-CoV-2/RS virus infection
Acronym
Evaluation of rapid diagnostic method for SARS-CoV-2/RS virus infection
Scientific Title
Evaluation of rapid diagnostic method for SARS-CoV-2/RS virus infection
Scientific Title:Acronym
Evaluation of rapid diagnostic method for SARS-CoV-2/RS virus infection
Region
| Japan |
Condition
Condition
COVID-19 infection, respiratory syncytial virus infection
Classification by specialty
| Infectious disease | Pediatrics | Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of rapid diagnostic method for SARS-CoV-2/RS virus infection
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sensitivity, specificity and limits of detection for rapid diagnostic methods for SARS-CoV-2 and respiratory syncytial virus infection
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver | Other |
Interventions/Control_1
Sample collection, assay with test kit
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 that visit the medical institution during this study, and include the following conditions:
1) Patients with symptoms suspected of COVID-19 infection or respiratory syncytial virus infection.
2) Patients who gave consent to this study.
Key exclusion criteria
1) Patients for whom sample collection is considered difficult.
2) Patients who gave consent to this study.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Tamura |
Organization
Jichi Medical University Hospital
Division name
Paediatrics
Zip code
329-0498
Address
3311-1 Yakushiji, Shimono-shi, Tochigi, 329-0498, Japan
TEL
0285-44-2111
dtamura@jichi.ac.jp
Public contact
Name of contact person
| 1st name | Yuta |
| Middle name | |
| Last name | Maehara |
Organization
Sekisui Medical Co., Ltd.
Division name
Research & Development
Zip code
103-0027
Address
1-3 Nihonbashi 2-chome, Chuo-ku Tokyo 103-0027, Japan
TEL
03-3272-0677
Homepage URL
yuta.maehara@sekisui.com
Sponsor or person
Institute
Sekisui Medical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Sekisui Medical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Eiju General Hospital , Zama Childrens Clinic, Ichikawa Childrens Clinic, Abe Childrens Clinic, Kobayashi International Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
-
Address
-
Tel
-
-
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 | 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
Main results already published
Date of protocol fixation
| 2021 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 13 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 13 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 08 | Month | 30 | Day |
Last modified on
| 2024 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055606
