UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053278 |
|---|---|
| Receipt number | R000060810 |
| Scientific Title | Retrospective observational study comparing comparing post-COVID conditions incidence in COVID-19 patients between ensitrelvir administration and administration/non-administration of anti-SARS-CoV-2 drugs using large-scale health insurance association data in Japan (3-month follow-up) |
| Date of disclosure of the study information | 2024/01/09 |
| Last modified on | 2024/01/10 18:39:09 |
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Basic information
Public title
Retrospective observational study comparing comparing post-COVID conditions incidence in COVID-19 patients between ensitrelvir administration and administration/non-administration of anti-SARS-CoV-2 drugs using large-scale health insurance association data in Japan (3-month follow-up)
Acronym
Retrospective observational study comparing comparing post-COVID conditions incidence in COVID-19 patients between ensitrelvir administration and administration/non-administration of anti-SARS-CoV-2 drugs using large-scale health insurance association data in Japan (3-month follow-up)
Scientific Title
Retrospective observational study comparing comparing post-COVID conditions incidence in COVID-19 patients between ensitrelvir administration and administration/non-administration of anti-SARS-CoV-2 drugs using large-scale health insurance association data in Japan (3-month follow-up)
Scientific Title:Acronym
Retrospective observational study comparing comparing post-COVID conditions incidence in COVID-19 patients between ensitrelvir administration and administration/non-administration of anti-SARS-CoV-2 drugs using large-scale health insurance association data in Japan (3-month follow-up)
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 post-COVID conditions incidence in COVID-19 patients with molnupiravir, nirmatrelvir or no antiviral as a control using the insurance claims database
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Post-COVID conditions incidence from 2 to 3 months after the month of diagnosis of COVID-19
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients whose index month (IM) of COVID-19 diagnosis is during the enrollment period (2022/11 to 2023/05).
2. Patients with observable period of 6 months before IM
3. Patients with observable period up to 3 months after IM
Key exclusion criteria
1. Patients under 18 years of age at the time of IM
2. Patients with dispending days of multiple anti-SARS-CoV-2 drugs in IM
3. Patients with a COVID-19 diagnosis within 3 months prior to IM
4. Patients who have been diagnosed with the same event as the post-COVID condition within 6 months before IM
5. Patients at risk of severe COVID-19
Target sample size
300000
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 | Takuji |
| Middle name | |
| Last name | Komeda |
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
070-7812-6558
Homepage URL
takuji.komeda@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
Japan
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
| 2024 | Year | 01 | Month | 09 | 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
| 2024 | Year | 01 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 01 | Month | 05 | 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
None
Management information
Registered date
| 2024 | Year | 01 | Month | 05 | Day |
Last modified on
| 2024 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060810
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| Registered date | File name |
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