UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054128 |
|---|---|
| Receipt number | R000061810 |
| Scientific Title | Ensitrelvir Fumaric Acid in Health care workers with SARS-CoV-2 Retrospective Chart Review - Tokyo Rinkai Hospital - |
| Date of disclosure of the study information | 2024/04/12 |
| Last modified on | 2025/04/10 12:02:42 |
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Basic information
Public title
Ensitrelvir Fumaric Acid in Health care workers with SARS-CoV-2 Retrospective Chart Review - Tokyo Rinkai Hospital -
Acronym
Ensitrelvir Fumaric Acid in Health care workers with SARS-CoV-2 Retrospective Chart Review - Tokyo Rinkai Hospital -
Scientific Title
Ensitrelvir Fumaric Acid in Health care workers with SARS-CoV-2 Retrospective Chart Review - Tokyo Rinkai Hospital -
Scientific Title:Acronym
Ensitrelvir Fumaric Acid in Health care workers with SARS-CoV-2 Retrospective Chart Review - Tokyo Rinkai 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 time to return to work for healthcare workers infected with SARS-CoV-2 who received ensitrelvir and those who did not receive antivirals.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Average number of days from onset of symptoms to return to work.
Key secondary outcomes
Virus residual rate proportion (antigen quantitative test >100 pg / ml) on the planned date of return to work for the re-examination.
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
Healthcare workers at Tokyo Rinkai Hospital who meet all of the following criteria are eligible for this study.
1)Healthcare workers who tested positive for SARS-CoV-2 at Tokyo Rinkai Hospital from Jun 2023 to Sep 2023
2)Healthcare workers who received ensitrevir according to the package insert or who did not receive anti-SARS-CoV-2 drugs.
3)Healthcare workers who can obtain all the following required data
If ensitrevir was administered, the start and end date of ensitrevir.
SARS-CoV-2 positive test result
Quantitative antigen test results on the scheduled day of return to work
Number of days from date of onset of COVID-19 to return to work
Key exclusion criteria
Healthcare workers at Tokyo Rinkai Hospital who meet any of the following criteria will be excluded from the study.
1)Healthcare workers who were not treated according to the package insert
2)Healthcare workers who received anti-SARS-CoV-2 drugs other than ensitrevir
3)Healthcare workers who refused to participate in this study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Katsuta |
Organization
Tokyo Rinkai Hospital
Division name
Pharmacy
Zip code
134-0086
Address
1-4-2 Rinkaicho, Edogawa-ku, Tokyo-to
TEL
03-5605-8811
katsuta-m@tokyorinkai.jp
Public contact
Name of contact person
| 1st name | Yasuko |
| Middle name | |
| Last name | Ariwa |
Organization
SHIONOGI & Co., Ltd.
Division name
Medical Affair
Zip code
541-0045
Address
1-8, Dosho-machi 3-chome, Chuo-ku, Osaka 541-0045, Japan
TEL
06-6202-2161
Homepage URL
yasuko.ariwa@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
Japan
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Rinkai Hospital
Address
1-4-2 Rinkaicho, Edogawa-ku, Tokyo-to
Tel
03-5605-8811
soumu@tokyorinkai.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 | 04 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/pii/S1341321X25000662#appsec1
Number of participants that the trial has enrolled
102
Results
The study enrolled 60 in the ensitrelvir(ETV) group and 42 in the non-antiviral(NA) group. The mean number of days to return-to-work was 6.9 days in the ETV group and 7.7days in the NA group. On the first scheduled date of return-to-work, 56.7% in the ETV group and 33.3% in the NA group had recovered, with the antigen test negativity in 76.7% and 52.4%, respectively.ETV treatment for healthcare workers COVID-19 to be associated with early symptom amelioration, and shorter time to return-to-work.
Results date posted
| 2025 | Year | 04 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
This study included data from electronic medical records of all healthcare workers who tested SARS-CoV-2 positive at Tokyo Rinkai Hospital through in-hospital loop-mediated isothermal amplification (LoopampEXIA; EIKEN CHEMICAL, Tokyo, Japan) or self-testing using an antigen kit between June 1 and September 30, 2023.
Participant flow
Adverse events
No side effects were observed in the ensitrelvir group.
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 01 | Month | 24 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 14 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 12 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2024 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2024 | Year | 08 | Month | 01 | Day |
Date analysis concluded
| 2024 | Year | 12 | Month | 31 | Day |
Other
Other related information
None
Management information
Registered date
| 2024 | Year | 04 | Month | 12 | Day |
Last modified on
| 2025 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061810
