UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059051 |
|---|---|
| Receipt number | R000067545 |
| Scientific Title | A Database Study Investigating Household Transmission Dynamics of COVID-19 and Influenza |
| Date of disclosure of the study information | 2025/09/30 |
| Last modified on | 2025/09/10 18:48:16 |
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Basic information
Public title
A Database Study Investigating Household Transmission Dynamics of COVID-19 and Influenza
Acronym
A Database Study Investigating Household Transmission Dynamics of COVID-19 and Influenza
Scientific Title
A Database Study Investigating Household Transmission Dynamics of COVID-19 and Influenza
Scientific Title:Acronym
A Database Study Investigating Household Transmission Dynamics of COVID-19 and Influenza
Region
| Japan |
Condition
Condition
SARS-CoV-2 infection, Influenza virus infection
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Using a health insurance claims database, this study aims to elucidate the household transmission patterns of COVID-19 and influenza both viral infectious diseases-by analyzing households with confirmed cases
Basic objectives2
Others
Basic objectives -Others
Viral transmission
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Event of Household Transmission Between Day 2 and Day 8 Following the Diagnosis Date (Day 1) of COVID-19 or Influenza
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
Households in which the index patient had a diagnosis date (Day 1) for COVID-19 or influenza during the inclusion period (November 30, 2021 to August 17, 2023).
Key exclusion criteria
(1) Households in which only the index patient was present during the same month as Day 1
(2) Households in which the index patient was hospitalized on Day 1
(3) Households with two or more index patients
Target sample size
1200000
Research contact person
Name of lead principal investigator
| 1st name | Kosaku |
| Middle name | |
| Last name | Komiya |
Organization
Oita university
Division name
Respiratory Medicine and Infectious Diseases
Zip code
879-5593
Address
1-1 Hasamamachi Idaigaoka, Yufu-shi, Oita
TEL
097-586-5804
komiyakh1@oita-u.ac.jp
Public contact
Name of contact person
| 1st name | Shogo |
| Middle name | |
| Last name | Miyazawa |
Organization
Shionogi & Co., Ltd.
Division name
Data Science Department
Zip code
541-0047
Address
4F, Midosuji MTR Building, 6-3, Awajimachi 3-chome, Chuo-ku, Osaka-shi, Osaka
TEL
090-3056-6073
Homepage URL
shogo.miyazawa@shionogi.co.jp
Sponsor or person
Institute
Shionogi & Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Shionogi & Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
NA
Address
NA
Tel
0000000000
XX@XX
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
| 2025 | Year | 09 | Month | 30 | 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
| 2024 | Year | 09 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2045 | Year | 12 | Month | 31 | Day |
Last follow-up date
| 2045 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Database study
Management information
Registered date
| 2025 | Year | 09 | Month | 10 | Day |
Last modified on
| 2025 | Year | 09 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067545
