UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041262 |
|---|---|
| Receipt number | R000047120 |
| Scientific Title | Observational study of SARS-CoV-2 antibody test positive rate. |
| Date of disclosure of the study information | 2020/08/01 |
| Last modified on | 2022/08/02 11:02:17 |
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Basic information
Public title
Observational study of SARS-CoV-2 antibody test positive rate.
Acronym
Observational study of SARS-CoV-2 antibody test positive rate.
Scientific Title
Observational study of SARS-CoV-2 antibody test positive rate.
Scientific Title:Acronym
Observational study of SARS-CoV-2 antibody test positive rate.
Region
| Japan |
Condition
Condition
SARS-CoV-2
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Conduct a SARS-CoV-2 antibody test and calculate the test positive rate.
Examine the influence of volunteers' factors on the test positive rate
Basic objectives2
Others
Basic objectives -Others
Epidemiological
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
SARS-CoV-2 antibody test positive rate.
Key secondary outcomes
Factors that influence on test positive rate
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
1, A subject, willing to take SARS-CoV-2 antibody test, gives written consent to the study.
Key exclusion criteria
1, A subject whose blood is difficult to collect.
2, A subject who the investigators think is not appropriate to the study.
Target sample size
4000
Research contact person
Name of lead principal investigator
| 1st name | Shin |
| Middle name | |
| Last name | Irie |
Organization
SOUSEIKAI
Division name
CEO
Zip code
813-0017
Address
3-5-1 Kashiiteriha, Higashi-ku, Fukuoka
TEL
0926623551
junko-manabe@lta-med.com
Public contact
Name of contact person
| 1st name | Tatsuya |
| Middle name | |
| Last name | Yoshihara |
Organization
SOUSEIKAI Fukuoka Mirai Hospital
Division name
Clinical Research Center
Zip code
813-0017
Address
3-5-1 Kashiiteriha, Higashi-ku, Fukuoka
TEL
0926623608
Homepage URL
tatsuya-yoshihara@lta-med.com
Sponsor or person
Institute
SOUSEIKAI
Institute
Department
Personal name
Funding Source
Organization
SOUSEIKAI
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hakata Clinic Institutional Review Board
Address
6-18 Tenyamachi, Hakata-ku, Fukuoka, Fukuoka
Tel
0922837701
miyako-koga@lta-med.com
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 | 08 | Month | 01 | Day |
Related information
URL releasing protocol
IJERPH | Free Full-Text | SARS-CoV-2 Seroprevalence among Healthcare Workers in General Hospitals an
Publication of results
Unpublished
Result
URL related to results and publications
IJERPH | Free Full-Text | SARS-CoV-2 Seroprevalence among Healthcare Workers in General Hospitals an
Number of participants that the trial has enrolled
2160
Results
IgG antibody positive rate was 1.2% in both Aug and Oct 2020, but excluding one facility where a nosocomial infection occurred in Apr, IgG antibody positive rate was 0.8% in both months. 21 of the 22 patients (95.5%) who were positive for IgG antibodies in Aug were also positive for IgG antibodies in Oct. Of the 28 patients who tested positive for IgG antibody at least once, 17 (60.7%) had symptoms suggestive of COVID-19 after Feb. 10 of 14 (71.4%) with a previous diagnosis of COVID-19 were IgG positive.
Results date posted
| 2022 | Year | 08 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A total of 2160 SOUSEIKAI workers who was working in August and October 2020 was tested untibody test.
Participant flow
Oral and written explanations were given and written informed consent was obtained prior to testing
Adverse events
Not analyzed.
Outcome measures
immunoglobulin (Ig)M and IgG antibodies
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 07 | Month | 21 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 31 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 10 | Month | 22 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Conduct a SARS-CoV-2 antibody test mainly on staff within organisation.
Management information
Registered date
| 2020 | Year | 07 | Month | 30 | Day |
Last modified on
| 2022 | Year | 08 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047120
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
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