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 | 2024/01/10 18:43:24 |
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
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
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
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
Japan |
COVID-19
Infectious disease |
Others
NO
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.
Efficacy
Others
Others
Not applicable
Hospitalization incidence (Days 2-28) with the date of diagnosis of COVID-19 as Day 1
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
Observational
18 | years-old | <= |
Not applicable |
Male and Female
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
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
180000
1st name | Yoshitake |
Middle name | |
Last name | Kitanishi |
Shionogi & Co., Ltd.
Data Science Department
541-0047
4F, Midosuji MTR Building, 6-3, Awajimachi 3-chome, Chuo-ku, Osaka-shi, Osaka
06-6202-2161
yoshitake.kitanishi@shionogi.co.jp
1st name | Shogo |
Middle name | |
Last name | Miyazawa |
Shionogi & Co., Ltd.
Data Science Department
541-0047
4F, Midosuji MTR Building, 6-3, Awajimachi 3-chome, Chuo-ku, Osaka-shi, Osaka
090-3056-6073
shogo.miyazawa@shionogi.co.jp
Shionogi & Co., Ltd.
Shionogi & Co., Ltd.
Profit organization
N/A : Not applicable due to database research
N/A : Not applicable due to database research
-
-
NO
2023 | Year | 12 | Month | 25 | Day |
Unpublished
Preinitiation
2023 | Year | 12 | Month | 22 | Day |
2023 | Year | 12 | Month | 22 | Day |
2025 | Year | 07 | Month | 31 | Day |
N/A:Not applicable due to database research
2023 | Year | 12 | Month | 25 | Day |
2024 | Year | 01 | Month | 10 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060735
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |