UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042599 |
|---|---|
| Receipt number | R000048622 |
| Scientific Title | Evaluation of SARS-CoV-2 Serum Antibody Titer in Pediatric Health Workers |
| Date of disclosure of the study information | 2020/12/01 |
| Last modified on | 2020/11/30 17:50:37 |
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Basic information
Public title
Evaluation of SARS-CoV-2 Serum Antibody Titer in Pediatric Health Workers
Acronym
Evaluation of SARS-CoV-2 Serum Antibody Titer in Pediatric Health Workers
Scientific Title
Evaluation of SARS-CoV-2 Serum Antibody Titer in Pediatric Health Workers
Scientific Title:Acronym
Evaluation of SARS-CoV-2 Serum Antibody Titer in Pediatric Health Workers
Region
| Japan |
Condition
Condition
COVID-19
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigate the risk of COVID-19 among pediatric health care workers and its relationship to subclinical infection and national epidemiology.
Basic objectives2
Others
Basic objectives -Others
Evaluate SARS-CoV-2 serum antibody titers in pediatric health care workers, symptoms during the observation period, and contact and morbidity with COVID-19 patients.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of COVID-19 among pediatric health care workers during the study period
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
Blood examinations will be performed 3 times.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Members of the Department of Pediatrics, St. Marianna University School of Medicine, who fully understand and consent to this research project will be eligible for the study.
Key exclusion criteria
If consent cannot be obtained, the person will not be considered eligible.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yukitsugu |
| Middle name | |
| Last name | Nakamura |
Organization
St. Marianna University School of Medicine
Division name
Department of Pediatrics
Zip code
216-8511
Address
2-16-1 Sugao, Miyamae-ku Kawasaki, Kanagawa
TEL
044-977-8111
y2nakamura@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Yukitsugu |
| Middle name | |
| Last name | Nakamura |
Organization
St. Marianna University School of Medicine
Division name
Department of Pediatrics
Zip code
216-851
Address
2-16-1 Sugao, Miyamae-ku Kawasaki, Kanagawa
TEL
044-977-8111
Homepage URL
y2nakamura@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
St. Marianna University School of Medicine
Address
2-16-1 Sugao, Miyamae-ku Kawasaki, Kanagawa
Tel
044-977-8111
y2nakamura@marianna-u.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 | 12 | 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
Preinitiation
Date of protocol fixation
| 2020 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 11 | Month | 30 | Day |
Last modified on
| 2020 | Year | 11 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048622
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
