UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040333 |
|---|---|
| Receipt number | R000046025 |
| Scientific Title | Fact-finding survey on subclinical infection of SARS-CoV-2 in Kanagawa Prefecture |
| Date of disclosure of the study information | 2020/05/08 |
| Last modified on | 2022/11/08 10:48:46 |
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Basic information
Public title
Fact-finding survey on subclinical infection of SARS-CoV-2 in Kanagawa Prefecture
Acronym
Fact-finding survey on subclinical infection of SARS-CoV-2 in Kanagawa Prefecture
Scientific Title
Fact-finding survey on subclinical infection of SARS-CoV-2 in Kanagawa Prefecture
Scientific Title:Acronym
Fact-finding survey on subclinical infection of SARS-CoV-2 in Kanagawa Prefecture
Region
| Japan |
Condition
Condition
COVID-19
Classification by specialty
| Medicine in general | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the actual condition of clinical sites and analyze the subclinical infection of SARS-CoV-2, the frequency of anamnesis of infection, and the relation to backgrounds in Kanagawa.
Basic objectives2
Others
Basic objectives -Others
epidemiologic study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
SARS-CoV-2 positivity rate in IgG antibody tests
Key secondary outcomes
Rates of SARS-CoV-2-positive patients in IgG antibody tests for different elements of patient backgrounds
SARS-CoV-2 positivity rate in IgG antibody tests (2,4 and 6 month after being found to be positive)
Clinical symptoms (2,4,6 and 12 month after being found to be positive)
SARS-CoV-2 positivity rate in IgG antibody tests in the doctor/nurse group (in 2021)
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) Patients who regularly visit medical institutions belonging to the Kanagawa Physicians Association or physicians and nurses employed at those institutions
2) All ages eligible
3) Those who are living in Japan and can participate in continuous follow-ups
4) Those who consent to participate in the study (in the case of minors, consent should be obtained from their legal guardian)
Key exclusion criteria
1) Those who have tested positive for SARS-CoV-2
2) Those who had cold-like symptoms such as a fever within the past 21 days
3) Those who had cold-like symptoms and/or a fever of 37.5 degrees or more for at least four days in 2020
4) Those who had extreme fatigue and/or dyspnea in 2020
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | Ikuro |
| Middle name | |
| Last name | Matsuba |
Organization
Kanagawa Physicians Association
Division name
Scientific Committee
Zip code
231-0037
Address
1-3 Fujimichou, Nakaku, Yokohama, Kanagawa
TEL
045-241-7000
ikuro@matsuba-web.com
Public contact
Name of contact person
| 1st name | Ikuro |
| Middle name | |
| Last name | Matsuba |
Organization
Kanagawa Physicians Association
Division name
Scientific Committee
Zip code
231-0037
Address
1-3 Fujimichou, Nakaku, Yokohama, Kanagawa
TEL
045-241-7000
Homepage URL
ikuro@matsuba-web.com
Sponsor or person
Institute
Kanagawa Physicians Association
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Kanagawa Physicians Association Ethical Review Special Committee
Address
1-3 Fujimichou, Nakaku, Yokohama, Kanagawa
Tel
045-241-7000
info@kanagawa.med.or.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 | 05 | Month | 08 | Day |
Related information
URL releasing protocol
https://www.jiac-j.com/article/S1341-321X(20)30325-1/fulltext
Publication of results
Published
Result
URL related to results and publications
https://www.jiac-j.com/article/S1341-321X(20)30325-1/fulltext
Number of participants that the trial has enrolled
1603
Results
The 39 in 1603 subjects (2.4%) were found to be IgG antibody-positive: 29 in the patient group (2.9%), 10 in the doctor/nurse group (2.0%), and 0 in the control group. After adjustment for age, sex, and the antibody prevalence in the control group, antibody prevalence was 2.7% in the patient group and 2.1% in the doctor/nurse group.
Intern Med. 2022 Jan 15;61(2):159-165. doi: 10.2169/internalmedicine.8019-21.
Intern Med. 2022 Oct 15;61(20):3053-3062. doi: 10.2169/internalmedicine.
Results date posted
| 2021 | Year | 11 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 09 | Month | 06 | Day |
Baseline Characteristics
The 39 in 1603 subjects (2.4%) were found to be IgG antibody-positive: 29 in the patient group (2.9%), 10 in the doctor/nurse group (2.0%), and 0 in the control group.
Participant flow
We then obtained consent from 33 of the 39 subjects who tested positive and performed follow-up for 12 months. Results Follow-up for up to 12 months showed that a long-term response of the anti-N IgG antibody could be detected in 6 of the 33 participants (18.2%).
Adverse events
nothing
Outcome measures
After adjustment for age, sex, and the antibody prevalence in the control group, antibody prevalence was 2.7% in the patient group and 2.1% in the doctor/nurse group.
We then obtained consent from 33 of the 39 subjects who tested positive and performed follow-up for 12 months. Results Follow-up for up to 12 months showed that a long-term response of the anti-N IgG antibody could be detected in 6 of the 33 participants (18.2%).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 04 | Month | 18 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 27 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 19 | Day |
Last follow-up date
| 2021 | Year | 07 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Obtain consent from the subject and then conduct an antibody test using serum followed by a survey.
Management information
Registered date
| 2020 | Year | 05 | Month | 08 | Day |
Last modified on
| 2022 | Year | 11 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046025
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| Registered date | File name |
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