UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040386 |
|---|---|
| Receipt number | R000046087 |
| Scientific Title | Evaluation of COVID-19 antigen test in COVID-19 suspected cases |
| Date of disclosure of the study information | 2020/07/01 |
| Last modified on | 2025/05/17 10:49:30 |
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Basic information
Public title
Evaluation of COVID-19 antigen test in COVID-19 suspected cases
Acronym
Evaluation of COVID-19 antigen test in COVID-19 suspected cases
Scientific Title
Evaluation of COVID-19 antigen test in COVID-19 suspected cases
Scientific Title:Acronym
Evaluation of COVID-19 antigen test in COVID-19 suspected cases
Region
| Japan |
Condition
Condition
COVID-19
Classification by specialty
| Medicine in general | Pneumology | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the results of COVID-19 antibody test between the patients who were positive for SARS-CoV-2 and those negative for SARS-CoV-2 in genetic test.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sensitivity, specificity, PPV, and NPV of COVID-19 antibody test in comparison with genetic test
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
1)COVID-19 suspected patient, 2)Patient who was performed genetic test, 3)Patient who was obtained blood sample
Key exclusion criteria
A patient who the attending doctor considered that a patient is not appropriate for the study.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Katsunori |
| Middle name | |
| Last name | Yanagihara |
Organization
Nagasaki University Hospital
Division name
Department of Laboratory Medicine
Zip code
852-8501
Address
1-7-1 Sakamoto, Nagasaki city
TEL
095-819-7574
k-yanagi@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Norihito |
| Middle name | |
| Last name | Kaku |
Organization
Nagasaki University Hospital
Division name
Department of Laboratory Medicine
Zip code
852-8501
Address
1-7-1 Sakamoto, Nagasaki city
TEL
095-819-7574
Homepage URL
kaku-ngs@umin.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
Nagasaki University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagasaki University Hospital
Address
Sakamoto 1-7-1, Nagasaki City
Tel
095-819-7229
gaibushikin@ml.nagasaki-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 | 07 | Month | 01 | Day |
Related information
URL releasing protocol
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0257452
Publication of results
Published
Result
URL related to results and publications
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0257452
Number of participants that the trial has enrolled
178
Results
The sensitivity, specificity, PPV, and NPV of ECLIA-detected total antibodies were 0.783, 1.000, 1.000, and 0.848, respectively. ELISA titers were significantly lower in LFA- and ECLIA-negative samples. In follow-up PCR-negative patients, total-antibody positivity was 72.4%.
Results date posted
| 2025 | Year | 05 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participants in this study were individuals who had tested positive for SARS-CoV-2 by genetic testing. After excluding those with negative initial test results and those who were hospitalized at the time of blood sample collection, asymptomatic or mildly symptomatic individuals were included in the final analysis. In addition, pre-pandemic blood samples collected at Nagasaki University Hospital were used as negative controls.
Participant flow
Blood samples were stored at -80 until antibody testing. Initially, ECLIA antibody tests were conducted accoording to the manufacturer's instructions. To investigate the causes of false-negative results, IgM and igG antibyody titeres against SARS-CoV-2 spike and nucleocapsid proteins were further measured using ELISA. Follow-up RT-PCR testing was conducted concurrently to assesss viral status.
Adverse events
None
Outcome measures
The main outcome measures were the sensitivity, specificity, positive predictive value, and negative predictive value of detecting anti-SARS-CoV-2 antibodies.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 05 | Month | 13 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 19 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2020 | Year | 05 | Month | 13 | Day |
Last modified on
| 2025 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046087
