UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040679 |
|---|---|
| Receipt number | R000046429 |
| Scientific Title | prospective cohort study of COVID-19/SARS-nCoV2 antibody for both medical doctors and dentists in Gunma Prefectural Cancer Center. |
| Date of disclosure of the study information | 2020/06/09 |
| Last modified on | 2022/12/08 13:29:20 |
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Basic information
Public title
prospective cohort study of COVID-19 antibody for medical stuff in hospital
Acronym
COVID-19 antibody study for medical stuff in GCC
Scientific Title
prospective cohort study of COVID-19/SARS-nCoV2 antibody for both medical doctors and dentists in Gunma Prefectural Cancer Center.
Scientific Title:Acronym
Prospective SARS-nCov2 antibody study in GCC
Region
| Japan |
Condition
Condition
COVID-19/SARS-nCoV2
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
evaluation of influence for medical care related with changes of antibodies of SARS-nCoV2 in both physician and dentists in single medical facility.
Basic objectives2
Others
Basic objectives -Others
evaluation of influence events for medical care other than changes of antibodies of SARS-nCoV2 in both physician and dentists in single medical facility.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
evaluation of changes of antibodies of SARS-nCoV2 in medical stuff.
Key secondary outcomes
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
physician and dentists in GCC
Key exclusion criteria
other than physician and dentists in GCC
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Araki |
Organization
Gunma prefectural cancer center
Division name
medical oncology
Zip code
373-8550
Address
617-1, Takabayashi-cho, Ohta
TEL
0276380771
kaz-araki@gunma-cc.jp
Public contact
Name of contact person
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Araki |
Organization
Gunma prefectural cancer center
Division name
medical oncology
Zip code
373-8550
Address
617-1, Takabayashi-cho, Ohta
TEL
0276380771
Homepage URL
kaz-araki@gunma-cc.jp
Sponsor or person
Institute
Gunma prefectural cancer center
Institute
Department
Personal name
Funding Source
Organization
Gunma prefectural cancer center
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
Gunma prefectural cancer center
Address
617-1, Takabayashi-cho, Ohta
Tel
0276380771
kaz-araki@gunma-cc.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 | 06 | Month | 09 | Day |
Related information
URL releasing protocol
https://www.mdpi.com/2571-841X/5/4/48
Publication of results
Published
Result
URL related to results and publications
https://www.mdpi.com/2571-841X/5/4/48
Number of participants that the trial has enrolled
10
Results
None of them experienced an allergic-like
reaction after the second vaccination, and the short-term immune response to the second vaccination
was similar in both groups.
Results date posted
| 2022 | Year | 12 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
10 HCW
Participant flow
6 initial participants, then additional participants
Adverse events
acute allergic like reaction
Outcome measures
SARS-CoV-2 anti-spike immunoglobulin G (IgG) r
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 05 | Month | 08 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 05 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 08 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 07 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
observational study
Management information
Registered date
| 2020 | Year | 06 | Month | 07 | Day |
Last modified on
| 2022 | Year | 12 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046429
