UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048027 |
|---|---|
| Receipt number | R000054675 |
| Scientific Title | SARS-CoV-2 Antigen Rapid Test (nasopharyngeal swab) INCP-502 Performance Evaluation Study |
| Date of disclosure of the study information | 2022/06/10 |
| Last modified on | 2023/01/12 13:40:22 |
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Basic information
Public title
Clinical Study Report of
SARS-CoV-2 Antigen Rapid Test
(nasopharyngeal swab)
INCP-502
Performance Evaluation Study
Acronym
SARS-CoV-2 Antigen Rapid Test
(nasopharyngeal swab)
INCP-502
Performance Evaluation Study
Scientific Title
SARS-CoV-2 Antigen Rapid Test
(nasopharyngeal swab)
INCP-502
Performance Evaluation Study
Scientific Title:Acronym
SARS-CoV-2 Antigen Rapid Test
(nasopharyngeal swab)
INCP-502
Performance Evaluation Study
Region
| Japan |
Condition
Condition
COVID-19
Classification by specialty
| Medicine in general | Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate SARS Coronavirus Antigen Kit, AllTest SARS-CoV-2 Antigen Rapid Test using local clinical specimens (nasopharyngeal swab).
Basic objectives2
Others
Basic objectives -Others
Performance evaluation study
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Comparison with approved antigen quantitation test.
2. To evaluate the results of a correlational study based on comparisons with an approved quantitative test for antigens using nasal swabs (Espline SARS-CoV-2, Fujirebio).
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
| 1 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The subjects must fulfill the following inclusion criteria:
A:Inclusion Criteria for Subjects
1.Subjects with suspected respiratory tract infection (SARS-CoV-2 infection) symptoms including fever, throat pain, dyspnea and ranging from minor to serious symptoms.
B:Inclusion Criteria for Samples
1.Remaining samples that can be used to confirm definite diagnosis.
2.Uncontaminated samples.
Key exclusion criteria
The presence of any of the following excludes a subject from study enrollment:
1.Overdue and deteriorated samples that were not collected, processed or stored as required.
2.Samples of patients with repeated enrolment (only valid samples of the first enrolment of the patient are retained).
3.Other samples that can be proved not to be operated according to the requirements of the scheme.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Moriyama |
Organization
Medical corporation Aiyukai Kanazawabunko Hospital
Division name
Director
Zip code
236-0042
Address
2-6-22 Kamariyahigashi, Kanazawa-ku, Yokohama-shi, Kanagawa,Japan
TEL
045-785-3311
y-oikawa@apoplus.co.jp
Public contact
Name of contact person
| 1st name | Yoshinobu |
| Middle name | |
| Last name | Oikawa |
Organization
APO PLUS STATION CO., LTD.
Division name
CRO Business Div.
Zip code
103-0027
Address
2-14-1 Nihonbashi, Chuo-ku, Tokyo,Japan
TEL
0363868800
Homepage URL
y-oikawa@apoplus.co.jp
Sponsor or person
Institute
Hangzhou AllTest Biotech Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
Hangzhou AllTest Biotech Co., Ltd
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical corporation Aiyukai Kanazawabunko Hospital
Address
2-6-22 Kamariyahigashi, Kanazawa-ku, Yokohama-shi, Kanagawa,Japan
Tel
045-785-3311
y-oikawa@apoplus.co.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 | 06 | Month | 10 | 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 | 04 | Month | 22 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 09 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
a
Management information
Registered date
| 2022 | Year | 06 | Month | 10 | Day |
Last modified on
| 2023 | Year | 01 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054675
