UMIN-CTR Clinical Trial

Basic information
Public title	Antibody acquisition and maintenance in childlen with COVID-19: Prospective observational study
Acronym	Pediatric COVID-19 Antibody Study
Scientific Title	Antibody acquisition and maintenance in childlen with COVID-19: Prospective observational study
Scientific Title:Acronym	Pediatric COVID-19 Antibody Study
Region	Japan

Condition
Condition	SARS-CoV-2 infection (COVID-19)
Classification by specialty	Infectious disease Pediatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the NP antibody titers at 14 (10 - 18) at 26 (20 - 32) and 52 (46 - 58) weeks after the date of the first positive PCR or other test for COVID-19.
Basic objectives2	Others
Basic objectives -Others	To evaluate the correlation between neutralizing activity and NP antibody titers by presence of symptoms, severity of disease, the distribution of neutralizing activity, NP and SP antibodies, and the correlation between neutralizing activity and SP antibody titers at 14 (10 - 18) and 26 (20 - 32) and 52 (46 - 58) weeks after the date of the first PCR or other positive results.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	NP antibody titers at 14 (10 - 18) and 26 (20 - 32) and 52 (46 - 58) weeks after the date of the first positive PCR or other test for COVID-19 infection
Key secondary outcomes	(1) Correlation between neutralizing activity and NP antibody titers at 14, 26 and 52 weeks after the first positive PCR. (2) Correlation between neutralizing activity and NP antibody titer by severity of disease. (3) Distribution of NP antibodies (quantitative and qualitative), SP antibodies (quantitative), neutralizing activity, cytokine, inflammatory markers (FABP, CRP and so on) and autoantibody by sex and age group. (4) Correlation between neutralizing activity and SP antibody titers. (5) Association of baseline background factors, treatment status and severity of disease with neutralizing activity values. (6) Association of baseline background factors, treatment status, and severity of disease with NP antibody titers. (7)Six types of antibody titer and neutralizing activity against human coronavirus. (8)Cytokines, inflammatory markers and autoantibody. (9)Neutralization activity value and antibody titer against SARS-CoV-2 and correlation of virus antibody titer and neutralizing activity against 6 human coronaviruses .

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	16 years-old >
Gender	Male and Female
Key inclusion criteria	Patients who meet all of the following criteria are eligible. (1) Patients who are under 16 years old at the time of registration. (2) Patients residing in Japan. (3) Patients with previous COVID-19 infection confirmed by the PCR or Lamp testing of pharyngeal swab, nasopharyngeal swab, or saliva. (4) Patients who have given their written informed consent to participate in this study.
Key exclusion criteria	Patients who meet the following criteria are excluded. (1) Patients with mental illness or other conditions that might affect their ability to consent (2) Patients who are deemed by the researcher to be unsuitable to participate in the research.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Takeharu Middle name Last name Yamanaka
Organization	Yokohama City University, School of Medicine
Division name	Department of Biostatistics
Zip code	236-0004
Address	3-9, Fukuura, Kanazawa-ku, Yokohama City
TEL	045-787-2572
Email	yamanaka@yokohama-cu.ac.jp

Public contact
Name of contact person	1st name Kenichi Middle name Last name Nishimura
Organization	Yokohama City University Hospital
Division name	Department of Pediatrics
Zip code	236-0004
Address	3-9, Fukuura, Kanazawa-ku, Yokohama City
TEL	045-787-2800
Homepage URL
Email	k_nsm@yokohama-cu.ac.jp

Sponsor
Institute	Yokohama City University
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
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
Address	3-9, Fukuura, Kanazawa-ku, Yokohama City
Tel	045-370-7627
Email	rinri@yokohama-cu.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 10 Month 01 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	No longer recruiting
Date of protocol fixation	2020 Year 09 Month 11 Day
Date of IRB	2020 Year 10 Month 22 Day
Anticipated trial start date	2020 Year 10 Month 23 Day
Last follow-up date	2022 Year 03 Month 12 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Prospective observational study Anticipated trial closure date: 2021/3/12

Management information
Registered date	2020 Year 09 Month 12 Day
Last modified on	2021 Year 03 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047674

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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