UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051482 |
|---|---|
| Receipt number | R000058732 |
| Scientific Title | Ensitrelvir Fumaric Acid in Hospitalized Patients with SARS-CoV-2 Retrospective Chart Review -Tomita Hospital- |
| Date of disclosure of the study information | 2023/06/30 |
| Last modified on | 2025/08/04 18:47:01 |
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Basic information
Public title
Ensitrelvir Fumaric Acid in Hospitalized Patients with COVID-19 Retrospective Chart Review -Tomita Hospital-
Acronym
Ensitrelvir Fumaric Acid in Hospitalized Patients with COVID-19 Retrospective Chart Review -Tomita Hospital-
Scientific Title
Ensitrelvir Fumaric Acid in Hospitalized Patients with SARS-CoV-2 Retrospective Chart Review -Tomita Hospital-
Scientific Title:Acronym
Ensitrelvir Fumaric Acid in Hospitalized Patients with SARS-CoV-2 Retrospective Chart Review -Tomita Hospital-
Region
| Japan |
Condition
Condition
COVID-19
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the background of hospitalized patients with SARS-CoV-2 infection who received ensitrelvir fumaric acid, the virologic and clinical outcomes, and safety.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Clinical symptoms, oxygen saturation, and food amount at each time point from the start to Day 10 of ensitrelvir administration.
Key secondary outcomes
Outcomes of SARS-CoV-2 infection up to 10 days after the 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
(1)Start date and end date of ensitrelvir administration
(2)SARS-CoV-2 positive test result
(3)Clinical symptoms after starting administration of ensitrelvir
(4)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
10
Research contact person
Name of lead principal investigator
| 1st name | Takafumi |
| Middle name | |
| Last name | Tomita |
Organization
Tomita Hospital
Division name
Director
Zip code
649-6253
Address
2, Kisendai Iwade-shi, Wakayama-ken
TEL
0736-62-1522
white-heaven@leto.eonet.ne.jp
Public contact
Name of contact person
| 1st name | Kentarou |
| Middle name | |
| Last name | Shibata |
Organization
Shionogi & Co., Ltd.
Division name
Medical Affairs
Zip code
100-0005
Address
7F, Tekko Building, 8-2, Marunouchi 1-chome, Chiyoda-ku, Tokyo
TEL
03-5219-7310
Homepage URL
kentarou.shibata@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
Non-Profit Organization MINS Institutional Review Board
Address
20-9-401,Mita 5-chome, Minato-ku, Tokyo
Tel
03-6416-1868
npo-mins@j-irb.com
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 | 30 | Day |
Related information
URL releasing protocol
DOI: 10.1097/MD.0000000000039080
Publication of results
Unpublished
Result
URL related to results and publications
DOI: 10.1097/MD.0000000000039080
Number of participants that the trial has enrolled
9
Results
All patients were female, 80 years old or older, and the mean age was 90.2 years. All patients recovered without worsening of COVID-19, and none received oxygen or additional antiviral drugs during the observation period: no deaths were reported within 14 days. After receiving ensitrelvir for 5 days, all patients had resolution of fever. There was no significant decrease in food intake of patients due to COVID-19.
Results date posted
| 2024 | Year | 08 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 07 | Month | 26 | Day |
Baseline Characteristics
All patients were female and hospitalized. All patients were at least 80 years old, with 4 patients (44.4%) over 90 years of age. All patients received ensitrelvir within 2 days of COVID-19 onset. Only 1 patient was unvaccinated against COVID-19; the other 8 patients had each received 2 or more COVID-19 vaccines.
Participant flow
Between November 2022 and April 2023, 11 patients at Tomita Hospital received ensitrelvir to treat SARS-CoV-2 infection
Adverse events
5 among the 9 patients had cough, 2 had sputum and 1 had sweating. Sputum suctioning was performed in the 2 patients with sputum, both of which had recovered by the end of ensitrelvir treatment.
Outcome measures
Clinical symptoms, oxygen saturation and mortality were evaluated for 14 days, including the day of initiation of ensitrelvir treatment. The outcome of SARS-CoV-2 infection in each patient was assessed by investigators according to clinical symptoms, including body temperature. Given that all patients in the study were 80 years of age or older and required long-term nursing care, it was not feasible to collect subjective symptoms of COVID-19 by interviewing patients. Therefore, each patients general condition was assessed based on the amount of food eaten for breakfast, lunch, and dinner. The food intake was quantified using a 10-point scale for the proportion of each main dish and side dish eaten, with a maximum score of 60 points per day.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 05 | Month | 08 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 22 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2023 | 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
| 2023 | Year | 06 | Month | 29 | Day |
Last modified on
| 2025 | Year | 08 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058732
