Tokyo, Jan. 31 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060523) titled 'Disease burden of COVID-19 under post-pandemic in Japanese population' on Jan. 31.
Study Type:
Observational
Primary Sponsor:
Institute - Takeda Pharmaceutical Company Limited
Condition:
Condition - COVID-19 and seasonal influenza
Classification by malignancy - Others
Genomic information - NO
Objective:
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
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 Size - 500000
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 01 Month 08 Day
Anticipated trial start date - 2026 Year 03 Month 31 Day
Last follow-up date - 2026 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069183
Disclaimer: Curated by HT Syndication.
