UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060523 |
|---|---|
| Receipt number | R000069183 |
| Scientific Title | Disease burden of COVID-19 under post-pandemic in Japanese population |
| Date of disclosure of the study information | 2026/01/31 |
| Last modified on | 2026/01/27 13:58:23 |
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Basic information
Public title
Disease burden of COVID-19 under post-pandemic in Japanese population
Acronym
Disease burden of COVID-19 under post-pandemic in Japanese population
Scientific Title
Disease burden of COVID-19 under post-pandemic in Japanese population
Scientific Title:Acronym
Disease burden of COVID-19 under post-pandemic in Japanese population
Region
| Japan |
Condition
Condition
COVID-19 and seasonal influenza
Classification by specialty
| Infectious disease | Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to quantitatively examine the disease burden of COVID-19 after its transition to a Category 5 infectious disease by using an insurance claims database and comparing it with seasonal influenza.
Basic objectives2
Others
Basic objectives -Others
Primary objective: To compare the proportion of the patients who admitted to hospital within 28 days after COVID-19 diagnosis and that after seasonal influenza diagnosis.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Hospitalization
Key secondary outcomes
Death
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
[COVID-19]
[1]. Having confirmed diagnosis of COVID-19 defined by a coding system of international Statistical Classification of Diseases and Related Health Problems 10th Revision (ICD-10 code) [U071, U072, B342] at least one from June 2023 to April 2025. Diagnosis without suspicion flag will be targeted.
[2]. Having specific SARS-CoV-2 detection test defined by the billing code or procedure code for the COVID-19 in the same month or the previous month as the diagnosis of COVID-19 detected at criteria [1].
[Seasonal influenza]
[1]. Having diagnosis of seasonal influenza defined by ICD-10 code [J09, J10, J11] at least one after June 2023 to April 2025. Diagnosis without suspicion flag will be targeted.
[2]. Having specific detection test defined by the billing code or procedure code for the seasonal influenza in the same month or the previous month as the diagnosis of seasonal influenza detected at criteria [1].
Key exclusion criteria
Patients with either COVID-19 or seasonal influenza must not meet any of the following criteria.
[1]. Available baseline period obtained by the ledger information is less than three months.
[2]. The index date of COVID-19 and seasonal influenza are identified in the same month.
[3]. For COVID-19 patients, the patients have confirmed COVID-19 diagnosis exists during the baseline period.
[4]. For seasonal influenza patients, the patients have confirmed seasonal influenza diagnosis exists during the baseline period.
Target sample size
500000
Research contact person
Name of lead principal investigator
| 1st name | Takayori |
| Middle name | |
| Last name | Ono |
Organization
Takeda Pharmaceutical Company Limited
Division name
Japan Medial Office
Zip code
103-8668
Address
1-1, Nihonbashi-Honcho 2-Chome, Chuo-ku, Tokyo
TEL
03-3278-2111
takayori.ono@takeda.com
Public contact
Name of contact person
| 1st name | Kiyoto |
| Middle name | |
| Last name | Naito |
Organization
Takeda Pharmaceutical Company Limited
Division name
Japan Medial Office
Zip code
103-8668
Address
1-1, Nihonbashi-Honcho 2-Chome, Chuo-ku, Tokyo
TEL
03-3278-2111
Homepage URL
kiyoto.naito@takeda.com
Sponsor or person
Institute
Takeda Pharmaceutical Company Limited
Institute
Department
Personal name
Funding Source
Organization
Takeda Pharmaceutical Company Limited
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
N/A
Address
N/A
Tel
N/A
N/A
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
| 2026 | Year | 01 | Month | 31 | 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
| 2026 | Year | 01 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 03 | Month | 31 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design: Cohort study using Japanese claim database
Data period: March 2023 - August 2025
Objectives other than primary objective:
Secondary objective: To compare the proportion of patients who died within 28 days after COVID-19 diagnosis and that after seasonal influenza diagnosis.
Exploratory objective To compare the proportion of patients who used intensive healthcare resources (ECMO, mechanical ventilation, ICU) within 28 days after COVID-19 diagnosis and that after seasonal influenza diagnosis.
Exploratory objective To compare the change in direct medical costs before/after the respective index diagnoses between patients with COVID-19 diagnosis and that before/after seasonal influenza.
Exploratory objective To compare the change in direct medical costs before/after the respective index diagnoses between patients with COVID-19 diagnosis and that before/after seasonal influenza, stratified by the patients' characteristics.
Exploratory objective [4]: To compare the change in frequency of outpatient visits before/after the COVID-19 diagnosis and that before/after the seasonal influenza diagnosis.
Management information
Registered date
| 2026 | Year | 01 | Month | 30 | Day |
Last modified on
| 2026 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069183
