UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051300 |
|---|---|
| Receipt number | R000058505 |
| Scientific Title | Ensitrelvir Fumaric Acid in Patients with SARS-CoV-2 - Retrospective Chart Review - |
| Date of disclosure of the study information | 2023/06/09 |
| Last modified on | 2024/03/12 21:53:00 |
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Basic information
Public title
Ensitrelvir Fumaric Acid in Patients with SARS-CoV-2 - Retrospective Chart Review -
Acronym
Ensitrelvir Fumaric Acid in Patients with SARS-CoV-2 - Retrospective Chart Review -
Scientific Title
Ensitrelvir Fumaric Acid in Patients with SARS-CoV-2 - Retrospective Chart Review -
Scientific Title:Acronym
Ensitrelvir Fumaric Acid in Patients with SARS-CoV-2 - Retrospective Chart Review -
Region
| Japan |
Condition
Condition
COVID-19
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will evaluate the background of patients with SARS-CoV-2 infection who received ensitrelvir fumaric acid (ensitrelvir), and the virologic and clinical outcomes and safety.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Viral antigen or PCR results (quantitative or qualitative results) at each time point from the start of administration to 10 days after the end of administration
Key secondary outcomes
Outcomes of SARS-CoV-2 infection up to 10 days after end of administration
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 who meet all of the following criteria are eligible for this study.
1) Patients who received ensitrelvir between November 2022 and April 2023
2) Patients who received ensitrelvir according to the package insert
3) Patients who have all the following required data
-Start date and end date of ensitrelvir administration
-SARS-CoV-2 positive test result
-Viral test results at the start and end of ensitrelvir administration
-Outcomes of SARS-CoV-2 infection
Key exclusion criteria
Patients who meet any of the following criteria are excluded from the study.
1) Patients who were treated "off-label"
2) Patients who refuse to participate in this study
Target sample size
52
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 Diseases Center
Zip code
598-8577
Address
2-23 Rinku Oraikita, Izumisano, Osaka
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
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
| 2023 | Year | 06 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/pii/S1341321X24000503?via%3Dihub
Number of participants that the trial has enrolled
51
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 02 | Month | 15 | Day |
Baseline Characteristics
At Rinku General Medical Center, between November 2022 and April 2023, total 52 patients received ensitrelvir for infections caused by SARS-CoV-2; 19 outpatients and 33 hospitalized patients. Because one inpatient used contraindicated drugs, 19 outpatients and 32 inpatients were evaluated in this study.
Average age of 19 outpatients was 41.0 years, of which 8 (42.1%) were male. All 19 cases (100%) had mild COVID-19. The main comorbid underlying diseases were dyslipidemia in 2 cases (10.5%) and hypertension in 2 cases (10.5%). Seven of the 19 patients (36.8%) had no follow-up data after initiation of ensitrevir.
The average age of the 32 hospitalized patients was 73.5 years, of which 18 (56.2%) were male. Twenty-one patients (65.6%) had mild COVID-19. All patients had underlying diseases, the most common of which were hypertension in 25 cases (78.1%) and chronic kidney disease in 8 cases (25.0%). Twenty-eight patients (87.5%) had received remdesivir treatment before receiving ensitrevir.
Participant flow
Adverse events
Outcome measures
[Outpatients]
Viral clearance was confirmed at the timing of final follow-up in 11 (91.7%) of the 12 patients. In addition, clinical improvement was observed in all 12 cases at follow-up visit. One of the 19 patients (5.3%) had a treatment-related adverse event (numbness symptoms).
[Hospitalized Patients]
Viral clearance was confirmed in 18 patients (56.3%) by end of ensitrevir treatment, and viral clearance was confirmed in 25 patients (78.1%) at the final follow-up. Clinical improvement was observed in all patients (100%) by end of ensitervir treatment. There were no ICU admissions or deaths due to COVID-19. In addition, no treatment-related adverse events were observed.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 04 | Month | 21 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 18 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 21 | Day |
Last follow-up date
| 2023 | Year | 05 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
| 2023 | Year | 10 | Month | 25 | Day |
Date analysis concluded
| 2023 | Year | 10 | Month | 25 | Day |
Other
Other related information
None
Management information
Registered date
| 2023 | Year | 06 | Month | 08 | Day |
Last modified on
| 2024 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058505
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| Registered date | File name |
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