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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000041769
Receipt No. R000047674
Scientific Title Antibody acquisition and maintenance in childlen with COVID-19: Prospective observational study
Date of disclosure of the study information 2020/10/01
Last modified on 2020/10/27

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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 (10 - 18) and 26 (20 - 32) and 52 (46 - 58) weeks after the first positive test for COVID-19 infection, including 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), and neutralizing activity at 14 (10 - 18) and 26 (20 - 32) and 52 (46 - 58) weeks after the first positive PCR or other test for COVID-19 infection by sex and age group.
(4) Correlation between neutralizing activity and SP antibody titers at 14 (10 - 18) and 26 (20 - 32) and 52 (46 - 58) weeks after the first positive test for COVID-19 infection, including PCR
(5) Association of baseline background factors, treatment status and severity of disease with neutralizing activity values at 14 (10 - 18) and 26 (20 - 32) and 52 (46 - 58) weeks after the first positive PCR or other test.
(6) Association of baseline background factors, treatment status, and severity of disease with NP antibody titers at 14 (10 - 18) and 26 (20 - 32) and 52 (46 - 58) weeks after the first positive PCR or other test for COVID-19 infection.

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 50

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 Open public 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 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Prospective observational study

Management information
Registered date
2020 Year 09 Month 12 Day
Last modified on
2020 Year 10 Month 27 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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