UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056047 |
|---|---|
| Receipt number | R000064019 |
| Scientific Title | Exploratory Assessment of Therapeutic Drug Utilization in Hospitalized Patients with COVID-19: An Observational Study |
| Date of disclosure of the study information | 2024/11/05 |
| Last modified on | 2025/05/09 18:23:21 |
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Basic information
Public title
A Study Investigating the Actual Use of Therapeutics in Patients Hospitalized with COVID-19
Acronym
Investigation of Therapeutic Use in COVID-19 Hospitalized Patients
Scientific Title
Exploratory Assessment of Therapeutic Drug Utilization in Hospitalized Patients with COVID-19: An Observational Study
Scientific Title:Acronym
Evaluation of Therapeutic Use in COVID-19 Hospitalized Patients
Region
| Japan |
Condition
Condition
COVID-19
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the patient background, clinical outcomes, and virological outcomes of hospitalized COVID-19 patients treated with Ensitrelvir Fumarate (hereafter, Ensitrelvir) or Remdesivir.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Survival at Day 28
Time to Discharge
SARS-CoV2 antigen titer
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
Patients meeting all of the following criteria will be included in this study:
1) Hospitalized patients treated with Ensitrelvir or Remdesivir between November 2022 and August 2024
2) Patients for whom all of the following essential data are available:
Start and end dates of treatment
Positive SARS-CoV-2 test result
COVID-19 outcomes
Key exclusion criteria
Patients who meet any of the following criteria are excluded from the study.
1) Patients who were treated "offlabel"
2) Patients who refuse to participate in this study
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Masaya |
| Middle name | |
| Last name | Yamato |
Organization
Rinku General Medical Center
Division name
General Internal Medicine/ Infectious Diseases, Department Infectious Disease Center
Zip code
598-8577
Address
2-23 Rinku Orikita, Izumisano, Osaka, Japan
TEL
072-469-3111
m-yamato@rgmc.izumisano.osaka.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Kinoshita |
Organization
Shionogi & Co., Ltd.
Division name
Medical Affairs
Zip code
541-0045
Address
1-8, Dosho-machi 3-chome, Chuo-ku, Osaka, Japan
TEL
06-6202-2161
Homepage URL
masahiro.kinoshita@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
Rinku General Medical Center Institutional Review Board
Address
2-23 Rinku Oraikita, Izumisano, Osaka
Tel
072-469-3111
rinri@rgmc.izumisano.osaka.jp
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 | 11 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s40121-025-01156-9
Number of participants that the trial has enrolled
539
Results
Ensitrelvir, a novel oral protease inhibitor for SARS-CoV-2, has been available in Japan since November 2022. A single-center study at Rinku General Medical Center compared outcomes of hospitalized COVID-19 patients treated with ensitrelvir (n=156) or remdesivir (n=337). Ensitrelvir showed lower 28-day mortality (1.9% vs. 5.9%), shorter time to discharge, and similar viral clearance. These results suggest its potential as an effective treatment, even in elderly or immunocompromised patients.
Results date posted
| 2025 | Year | 05 | Month | 09 | Day |
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
Completed
Date of protocol fixation
| 2024 | Year | 08 | Month | 03 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 20 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 06 | Day |
Last follow-up date
| 2024 | Year | 11 | Month | 06 | Day |
Date of closure to data entry
| 2024 | Year | 11 | Month | 20 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Exploratory Observational Study
We plan to aggregate exploratory data using existing information from a single facility.
Management information
Registered date
| 2024 | Year | 11 | Month | 05 | Day |
Last modified on
| 2025 | Year | 05 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064019
