UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050806 |
|---|---|
| Receipt number | R000057893 |
| Scientific Title | Comparison of incidence of severe outcomes between COVID-19 and influenza in outpatients without risk factors using health insurance claims database |
| Date of disclosure of the study information | 2023/04/17 |
| Last modified on | 2024/04/17 18:09:01 |
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Basic information
Public title
Comparison of incidence of severe outcomes between COVID-19 and influenza in outpatients without risk factors using health insurance claims database
Acronym
Comparison of incidence of severe outcomes between COVID-19 and influenza in outpatients without risk factors using health insurance claims database
Scientific Title
Comparison of incidence of severe outcomes between COVID-19 and influenza in outpatients without risk factors using health insurance claims database
Scientific Title:Acronym
Comparison of incidence of severe outcomes between COVID-19 and influenza in outpatients without risk factors using health insurance claims database
Region
| Japan |
Condition
Condition
SARS-CoV-2 infection and Influenza virus infection
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the frequency of severe events after contracting novel coronavirus disease (COVID-19) and seasonal influenza in a population without risk factors for severe disease
Basic objectives2
Others
Basic objectives -Others
Epidemiology
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Hospitalization within 4 weeks after consultation, oxygen inhalation,
respiratory rate monitoring, ventilator, ICU admission, presence or absence of death within the next month
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
[COVID-19 patient]
Patients diagnosed between January 2020 and July 2022
[Influenza patient]
Patients diagnosed between October 2017 and September 2019
[Common to COVID-19 and influenza patients]
It has information on the date of onset (Day1). Day 1 is defined as the minimum start date of medical care in the minimum month of the diagnosis of the disease.
1, The diagnosis record that identifies Day 1 is an outpatient receipt
2, Outpatient treatment or drug prescription on Day 1
3, Observation start date is 6 or more than 6 months before the month including Day 1
4, Observation end date is a month after the month including Day1
Key exclusion criteria
Hospitalized on Day1
Risk factors for aggravation (age, malignant tumor, chronic respiratory disease, chronic kidney disease, diabetes, hypertensive disease, dyslipidemia, cardiovascular disease, cerebrovascular disease) disease, morbid obesity, immunosuppressive status, AIDS/HIV)
Target sample size
570000
Research contact person
Name of lead principal investigator
| 1st name | Yoshitake |
| Middle name | |
| Last name | Kitanishi |
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
06-6209-1103
yoshitake.kitanishi@shionogi.co.jp
Public contact
Name of contact person
| 1st name | Satoki |
| Middle name | |
| Last name | Fujita |
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
06-6209-1103
Homepage URL
satoki.fujita@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
XXXX@XXXX
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
| 2023 | Year | 04 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1016/j.jcvp.2023.100175
Number of participants that the trial has enrolled
1670991
Results
Adjusted odds ratios from diagnosis for each severe events (hospitalization, respiratory and heart rate monitoring, oxygen therapy, ventilator use, intensive care unit admission within 28 days, and death within the following month) were significantly higher for patients with COVID-19 than with FLU.
Results date posted
| 2024 | Year | 04 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 12 | Month | 26 | Day |
Baseline Characteristics
Patients with an ICD-10 code of U071 or U072 were for COVID-19 between January 2020 and August 2022. Patients with an ICD-10 code of J09, J10, or J11 were for seasonal influenza between October 2017 and September 2019.
Participant flow
See Figure 1 in the manuscript
https://doi.org/10.1016/j.jcvp.2023.100175
Adverse events
Not collected
Outcome measures
Hospitalization, respiratory and heart rate monitoring, oxygen therapy, ventilator use, ICU admission within 4 weeks from diagnosis, presence or absence of death within the following month
Plan to share IPD
NA
IPD sharing Plan description
NA
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 04 | Month | 10 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 20 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 10 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
NA
Management information
Registered date
| 2023 | Year | 04 | Month | 10 | Day |
Last modified on
| 2024 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057893
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