UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040744 |
|---|---|
| Receipt number | R000046508 |
| Scientific Title | Clinical study to evaluate the efficiency of specific antibody against SARS-CoV-2 |
| Date of disclosure of the study information | 2020/06/16 |
| Last modified on | 2022/05/19 17:57:42 |
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Basic information
Public title
Clinical study to evaluate the efficiency of specific antibody against SARS-CoV-2 for the purpose of its social implementation
Acronym
Clinical study to evaluate the efficiency of specific antibody against SARS-CoV-2
Scientific Title
Clinical study to evaluate the efficiency of specific antibody against SARS-CoV-2
Scientific Title:Acronym
Clinical study to evaluate the efficiency of specific antibody against SARS-CoV-2
Region
| Japan |
Condition
Condition
Patients who are scheduled to be hospitalization to Yokohama City University Hospital and Yokohama City university medical center
Classification by specialty
| Medicine in general | Gastroenterology | Hepato-biliary-pancreatic medicine |
| Cardiology | Pneumology | Endocrinology and Metabolism |
| Hematology and clinical oncology | Nephrology | Neurology |
| Clinical immunology | Psychosomatic Internal Medicine | Infectious disease |
| Geriatrics | Surgery in general | Gastrointestinal surgery |
| Hepato-biliary-pancreatic surgery | Vascular surgery | Chest surgery |
| Endocrine surgery | Breast surgery | Obstetrics and Gynecology |
| Ophthalmology | Dermatology | Psychiatry |
| Oto-rhino-laryngology | Orthopedics | Urology |
| Oral surgery | Neurosurgery | Cardiovascular surgery |
| Plastic surgery | Emergency medicine | Intensive care medicine |
| Rehabilitation medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We examine how many patients without any clinical symptoms related to SARS-CoV-2 have NP antibody. In addition, we will examine the relationship between NP antibody and neutralizing activity in patients with subclinical infections by conducting antibody tests over time.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fixed-point and time-course prevalence of NP antibody in patients without any clinical symptoms related to SARS-CoV-2
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
We examine how many patients who never be diagnosed as COVID-19 have NP antibody. In addition, we will examine the relationship between NP antibody and neutralizing activity in patients with subclinical infections by conducting antibody tests over time.
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
| 6 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Patients scheduled to be admitted to Yokohama City University Hospital or Yokohama City University Medical Center
(2) Patients over 6 years old
(3) Patients living in Japan
(4) Patients who can collect nasopharyngeal swab and collect blood. If the PCR test using saliva sample can be performed within the insurance medical care, it is allowed
(5) Patients who have obtained sufficient explanation about the research content and agreed to the document in writing, or when the participant himself/herself does not have the responsibility for consent, the relatives with whom he/she lives become a delegate and obtain consent.
Key exclusion criteria
(1) Patients who are already hospitalized
(2) Patients suspected to be infected with COVID-19 such as common cold symptoms, upper respiratory tract symptoms, 37.5 degrees or more
(3) Patients who are thought to have an effect on consent ability, such as mental illness
(4) Patients with a new coronavirus infection in the past
(5) Other patients who the investigator determined to be unsuitable for study participation
Target sample size
5000
Research contact person
Name of lead principal investigator
| 1st name | tomoyuki |
| Middle name | |
| Last name | miyazaki |
Organization
Yokohama city university hospital
Division name
Dept. Anesthesiology
Zip code
236-0004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama
TEL
045-787-2800
johney@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Mie |
| Middle name | |
| Last name | Tsuchiya |
Organization
Yokohama city university hospital
Division name
Clinical trial support center
Zip code
236-0004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama
TEL
045-787-2800
Homepage URL
johney@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama city university
Institute
Department
Personal name
Funding Source
Organization
AMED
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yokohama city university hispital ethic comittee
Address
3-9 Fukuura, Kanazawa-ku, Yokohama
Tel
045-370-7627
none
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 | 06 | Month | 16 | 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
3244
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
Completed
Date of protocol fixation
| 2020 | Year | 06 | Month | 11 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 11 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 22 | Day |
Last follow-up date
| 2020 | Year | 10 | 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
| 2020 | Year | 06 | Month | 12 | Day |
Last modified on
| 2022 | Year | 05 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046508
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
