UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041769 |
|---|---|
| Receipt number | 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 | 2023/09/21 11:13:40 |
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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, 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 | Shuichi |
| Middle name | |
| Last name | Ito |
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
itoshu@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
k_nsm@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
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
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
None
Publication of results
Unpublished
Result
URL related to results and publications
None
Number of participants that the trial has enrolled
73
Results
Positivity for NP-IgG was 91% (n=45), 81% (n=53), and 53% (n=36) at 14, 26, and 52 weeks, respectively.
Positivity for SP-IgG was 96% (n=45), 96% (n=53), and 92% (n=36) at 14, 26, and 52 weeks, respectively.
NP-IgG and NT50 at 14 weeks were positively correlated (Spearman's correlation coefficient =0.47).
There was no significant association between NT50 titer and age, gender, or severity of disease at 52 weeks.
Translated with www.DeepL.com/Translator (free version)
Results date posted
| 2023 | Year | 09 | Month | 21 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The median age at diagnosis was 4 (IQR 1-7) years, and 55.6% were boys.
The severity of disease was asymptomatic, mild, moderate, and severe in 21%, 74%, 6%, and 0%, respectively.
Participant flow
Patients diagnosed with COVID-19 by PCR or other tests and requiring hospitalization will be enrolled after written consent is obtained using the consent explanation document.
Blood samples will be collected 14, 26, and 52 weeks after the date of the first positive PCR or other test.
Adverse events
None
Outcome measures
(1) Background information
Presence of symptoms, date of onset, date of diagnosis, date of admission, sex, date of birth, height and weight at diagnosis, race, BCG vaccination history, route of infection, perinatal history, presence of underlying disease, treatment for underlying disease, SpO2 at diagnosis, blood laboratory values (white blood cell count, lymphocyte fraction, CRP, LDH(U/L), ferritin, D-dimer ), presence/absence, frequency, and date of vaccination with novel coronavirus vaccine, and recurrent COVID-19
(2) Information on COVID-19 disease status during the course of the disease
Presence or absence of symptoms (fever, cough, nasal discharge, sore throat, abnormal taste, olfaction, vomiting, diarrhea, skin symptoms), presence or absence of abnormal shadows confirmed by Xp or CT, diagnosis of Kawasaki disease, presence or absence of redness at BCG vaccination site
(3) Drugs administered for COVID-19
Presence or absence and details
(4) Outcome
Date of confirmation of negative PCR or other tests, date of resolution of fever, improvement of imaging findings, duration of oxygen administration, presence or absence of non-invasive ventilation or high-flow oxygen therapy, presence or absence of invasive mechanical ventilation by intubation, presence or absence of ECMO, duration of hospitalization
(5) Central measurement tests (specimens)
Neutralizing activity value and NP antibody titer (qualitative and quantitative) and SP antibody titer (quantitative)
Translated with www.DeepL.com/Translator (free version)
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 | 09 | Month | 10 | 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: 2021/9/10
Management information
Registered date
| 2020 | Year | 09 | Month | 12 | Day |
Last modified on
| 2023 | Year | 09 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047674
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