UMIN-CTR Clinical Trial

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 Obsterics 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
Email	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
Email	johney@yokohama-cu.ac.jp

Sponsor
Institute	Yokohama city university
Institute
Department

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
Email	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	2021 Year 09 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046508