UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044519 |
|---|---|
| Receipt number | R000050864 |
| Scientific Title | COVID-19 Antibody quantification and vaccination history and association with viral genotype (variant) |
| Date of disclosure of the study information | 2021/06/13 |
| Last modified on | 2022/12/14 19:05:46 |
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Basic information
Public title
COVID-19 Antibody quantification and vaccination history and association with viral genotype (variant)
Acronym
COVID-19 Antibody quantification and vaccination history and association with viral genotype (variant)
Scientific Title
COVID-19 Antibody quantification and vaccination history and association with viral genotype (variant)
Scientific Title:Acronym
COVID-19 Antibody quantification and vaccination history and association with viral genotype (variant)
Region
| Japan |
Condition
Condition
COVID-19
Classification by specialty
| Infectious disease | Laboratory medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to quantify antibodies to COVID-19 and vaccination history, and the relationship between vaccination history and viral genotype (variant)
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Subject's present illness, past history, life history
1. Basic information of research subjects: age, gender, diagnosis name, family history, medical history, drug treatment history, allergy history, fever, height, weight, body mass index, physical findings, symptoms
2. Presence or absence of symptoms at the time of vaccination,
3. Laboratory data
SARS-CoV-2 IgG antibody, IgM antibody, viral genome genotype
Leukocytes, CRP, AST, ALT, LD, ALP, gamma GT, IgG, IgE, IgA, IgM
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Vaccine |
Interventions/Control_1
Patients affected after vaccination with the new coronavirus will be observed for 1 year after vaccination.
Interventions/Control_2
Observe healthy subjects after vaccination with the new coronavirus vaccine for 1 year after vaccination.
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Those who have been or are planning to be vaccinated against the new coronavirus infection
2. Those who are 16 years of age or older at the time of obtaining the consent form
3. The target audience for Theme 1 and Theme 2 may be slack.
4. Basically, a person who has received sufficient explanation before participating in this research, and after sufficient understanding, obtained the voluntary written consent of the research subject. Alternatively, the outline of this test will be posted and announced.
Key exclusion criteria
1. Those who have requested refusal to participate in this research
2. In addition, those who the principal investigator deems inappropriate as research subjects
3. When this research is discontinued by the entire organization conducting the research
4. Those who have an urgent and obvious life threat to the research subject
Of the above (1) target patients, those who meet all of the (2) selection criteria and do not meet any of the (3) exclusion criteria are eligible.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Tomohiro |
| Middle name | |
| Last name | Nakayama |
Organization
Nihon University School of Medicine Itabashi Hospital
Division name
Laboratory Madicine
Zip code
173-8610
Address
Ooyaguchi-kamimachi 30-1
TEL
+81339728111
nakayama.tomohiro@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Hisamitsu |
| Middle name | |
| Last name | Ishihara |
Organization
Nihon University School of Medicine Itabashi Hospital
Division name
Internal Medicine
Zip code
173-8610
Address
Ooyaguchi-kamimachi 30-1
TEL
08017298076
Homepage URL
nakayama.tomohiro@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University School of Medicine Itabashi Hospital
Institute
Department
Personal name
Funding Source
Organization
Nihon University School of Medicine, Division of Laboratory Medicine, Department of Pathology and Microbiology
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nihon University School of Medicine Itabashi Hospital
Address
Ooyaguchi-kamimachi 30-1
Tel
03-3972-8111
nakayama.tomohiro@nihon-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
| 2021 | Year | 06 | Month | 13 | 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
2
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 | 06 | Month | 14 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 30 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 14 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2026 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2026 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 06 | Month | 13 | Day |
Last modified on
| 2022 | Year | 12 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050864
