UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053217 |
|---|---|
| Receipt number | R000060735 |
| Scientific Title | Cohort study comparing severe incidence in COVID-19 patients at high risk of severe illness between ensitrelvir administration and administration/non-administration of anti-SARS-CoV-2 drugs using large-scale health insurance association data in Japan |
| Date of disclosure of the study information | 2023/12/25 |
| Last modified on | 2025/06/30 18:17:18 |
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Basic information
Public title
Cohort study comparing severe incidence in COVID-19 patients at high risk of severe illness between ensitrelvir administration and administration/non-administration of anti-SARS-CoV-2 drugs using large-scale health insurance association data in Japan
Acronym
Cohort study comparing severe incidence in COVID-19 patients at high risk of severe illness between ensitrelvir administration and administration/non-administration of anti-SARS-CoV-2 drugs using large-scale health insurance association data in Japan
Scientific Title
Cohort study comparing severe incidence in COVID-19 patients at high risk of severe illness between ensitrelvir administration and administration/non-administration of anti-SARS-CoV-2 drugs using large-scale health insurance association data in Japan
Scientific Title:Acronym
Cohort study comparing severe incidence in COVID-19 patients at high risk of severe illness between ensitrelvir administration and administration/non-administration of anti-SARS-CoV-2 drugs using large-scale health insurance association data in Japan
Region
| Japan |
Condition
Condition
COVID-19
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the efficacy of ensitrelvir in reducing the severe incidence in COVID-19 patients at high risk of severe illness using the insurance claims database as a control for Molnupiravir, Nirmatrelvir or No antiviral treatment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Hospitalization incidence (Days 2-28) with the date of diagnosis of COVID-19 as Day 1
Key secondary outcomes
Each of the following incidence from Day 2 to Day 28
･Use of ventilator
･ICU
･Oxygen inhalation
･Respiratory rate monitoring
Each of the following incidence up to the next month of Day 1
･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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients whose Day 1 was during the inclusion period (November 22, 2022-July 31, 2023)
2. Patients who were diagnosed with the COVID-19 as outpatients (Day 1)
3. Patients who were recorded as outpatients (Day 1)
4. Patients who had an observation period for the past 6 months from Day 1
5. Patients who had an observation period up to the next month of Day 1
6. Patients who had high risk factors for severe COVID-19 development
Key exclusion criteria
1. Patients under 18 years old
2. Patients who were hospitalized on Day 1
3. Patients who were prescribed two or more therapeutic drugs on Day 1
Target sample size
180000
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
06-6202-2161
yoshitake.kitanishi@shionogi.co.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
N/A : Not applicable due to database research
Address
N/A : Not applicable due to database research
Tel
-
-
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 | 12 | Month | 25 | Day |
Related information
URL releasing protocol
https://doi.org/10.1007/s40121-024-01010-4
Publication of results
Unpublished
Result
URL related to results and publications
https://doi.org/10.1007/s40121-024-01010-4
Number of participants that the trial has enrolled
167310
Results
The risk ratio for all-cause hospitalization between the ensitrelvir group (n = 167,385) and the no antiviral treatment group (n = 167,310) after IPTW adjustment was 0.629 [95% confidence interval (CI) 0.420, 0.943]. The risk difference was -0.291 [95% CI -0.494, -0.088]. The incidence of both respiratory and heart rate monitoring and oxygen therapy was lower in the ensitrelvir group. Ventilator use, intensive care admission, and all-cause death were difficult to assess because of the limited events.
Results date posted
| 2025 | Year | 06 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 06 | Month | 28 | Day |
Baseline Characteristics
From November 2022 to July 2023, during the Omicron dominant period, 167,310 eligible patients were identified in the JMDC claims database. Of those patients, 5177 (3.1%) were treated with ensitrelvir and 162,133 (96.9%) received no antiviral treatment.
In the high-risk for severe COVID-19 population, characteristics of patients were generally similar between those who received ensitrelvir and no antiviral treatment. After IPTW adjustment, the SMDs between the ensitrelvir and no antiviral treatment groups were <0.1 for all characteristics, indicating that the baseline characteristics were well-balanced after adjustment.
Participant flow
Of the 17,025,432 people registered in the JMDC, 1,054,369 people who were diagnosed with COVID-19 between November 22, 2022 and July 31, 2023 were identified, and 167,310 outpatients (excluding those under 18 years of age) with high-risk factors for severe COVID-19 who were not hospitalized on Day 1 were analyzed in this study.
Adverse events
Not evaluated in this study
Outcome measures
the incidence of all-cause hospitalization
Plan to share IPD
No plan
IPD sharing Plan description
No plan
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 12 | Month | 22 | Day |
Date of IRB
| 2045 | Year | 12 | Month | 31 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 22 | Day |
Last follow-up date
| 2025 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
No ethics committee required as the study uses an anonymized database
Management information
Registered date
| 2023 | Year | 12 | Month | 25 | Day |
Last modified on
| 2025 | Year | 06 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060735
