![]() |
UMIN-CTR Clinical Trial |
|
![]() |
![]() |
![]() |
![]() |
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 |
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 |
|
Condition | |||
Condition | SARS-CoV-2 infection (COVID-19) | ||
Classification by specialty |
|
||
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 |
|
|||
Age-upper limit |
|
|||
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 |
|
||||||
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 | ||||||
yamanaka@yokohama-cu.ac.jp |
Public contact | |||||||
Name of contact person |
|
||||||
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 | |
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 |
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 |
|
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 |
|
||||||
Date of IRB |
|
||||||
Anticipated trial start date |
|
||||||
Last follow-up date |
|
||||||
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 |
|
||||||
Last modified on |
|
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 |