Unique ID issued by UMIN | UMIN000041769 |
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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 |
Antibody acquisition and maintenance in childlen with COVID-19: Prospective observational study
Pediatric COVID-19 Antibody Study
Antibody acquisition and maintenance in childlen with COVID-19: Prospective observational study
Pediatric COVID-19 Antibody Study
Japan |
SARS-CoV-2 infection (COVID-19)
Infectious disease | Pediatrics |
Others
NO
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.
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.
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
(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 .
Observational
Not applicable |
16 | years-old | > |
Male and Female
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.
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.
100
1st name | Shuichi |
Middle name | |
Last name | Ito |
Yokohama City University Hospital
Department of Pediatrics
236-0004
3-9, Fukuura, Kanazawa-ku, Yokohama City
045-787-2800
itoshu@yokohama-cu.ac.jp
1st name | Kenichi |
Middle name | |
Last name | Nishimura |
Yokohama City University Hospital
Department of Pediatrics
236-0004
3-9, Fukuura, Kanazawa-ku, Yokohama City
045-787-2800
k_nsm@yokohama-cu.ac.jp
Yokohama City University
Japan Agency for Medical Research and Development
Government offices of other countries
Yokohama City University
3-9, Fukuura, Kanazawa-ku, Yokohama City
045-370-7627
rinri@yokohama-cu.ac.jp
NO
2020 | Year | 10 | Month | 01 | Day |
None
Unpublished
None
73
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)
2023 | Year | 09 | Month | 21 | Day |
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.
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.
None
(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)
No longer recruiting
2020 | Year | 09 | Month | 11 | Day |
2020 | Year | 10 | Month | 22 | Day |
2020 | Year | 10 | Month | 23 | Day |
2022 | Year | 09 | Month | 10 | Day |
Prospective observational study
Anticipated trial closure date: 2021/9/10
2020 | Year | 09 | Month | 12 | Day |
2023 | Year | 09 | Month | 21 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047674
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