UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049727 |
|---|---|
| Receipt number | R000056642 |
| Scientific Title | Xocova tablets drug use-results survey |
| Date of disclosure of the study information | 2022/12/08 |
| Last modified on | 2025/08/04 18:45:55 |
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Basic information
Public title
Xocova tablets drug use-results survey
Acronym
Xocova tablets drug use-results survey
Scientific Title
Xocova tablets drug use-results survey
Scientific Title:Acronym
Xocova tablets drug use-results survey
Region
| Japan |
Condition
Condition
SARS-CoV-2 infection
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess safety and clinical outcome of Xocova tablets under clinical practice.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Safety
Incidence of adverse drug reactions
Key secondary outcomes
Clinical outcome
Time to resolution of COVID-19 symptoms in SARS-CoV-2 infected patients
The number and rate of hospitalization for COVID-19 or death from any cause through day 28
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
| 12 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
SARS-CoV-2 infected patient who has not been treated with Xocova tablets and provides an informed consent in written for data collection and analysis
Key exclusion criteria
NA
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | Masako |
| Middle name | |
| Last name | Kaneto |
Organization
Shionogi & Co., Ltd.
Division name
Pharmacovigilance Department
Zip code
541-0042
Address
3-13, Imabashi 3-Chome, Chuo-ku, Osaka 541-0042, Japan
TEL
+81-6-6209-6974
masako.kaneto@shionogi.co.jp
Public contact
Name of contact person
| 1st name | Satoru |
| Middle name | |
| Last name | Takashima |
Organization
Shionogi & Co., Ltd.
Division name
Pharmacovigilance Department
Zip code
541-0042
Address
3-13, Imabashi 3-Chome, Chuo-ku, Osaka 541-0042, Japan
TEL
+81-6-6209-6929
Homepage URL
satoru.takashima@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
NA
Address
NA
Tel
NA
NA
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
| 2022 | Year | 12 | Month | 08 | Day |
Related information
URL releasing protocol
https://doi.org/10.1016/j.jiac.2024.12.003
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1016/j.jiac.2024.12.003
Number of participants that the trial has enrolled
3760
Results
A total of 3760 and 3638 patients were included in the safety and effectiveness analysis sets, respectively. In the safety analysis set, the mean (SD) age was 43.6 (17.7) years, 48.5% were male, 97.5% had mild COVID-19, and 73.4% had a vaccination history. Of the 379 ADRs reported, 374 were not serious and 5 were serious. None of the ADRs resulted in sequelae or death. The median time to resolution of fever and all symptoms was 36.0 and 156.0 h, respectively.
Results date posted
| 2025 | Year | 06 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 12 | Month | 03 | Day |
Baseline Characteristics
n the safety analysis set, the mean (SD) age was 43.6 (17.7) years, 12.0% of patients were aged 65 years or older and 8.5 % were >70 years. Overall, there were 48.5 % of males, and 86.6 % of patients did not have a history of COVID-19 infection. A total of 73.4 % of patients had received the COVID-19 vaccine, with a large proportion (31.9 %) having received 3 doses, followed by 4 doses (21.2 %). The pre-treatment COVID-19 severity was mild, moderate I, asymptomatic, and moderate II in 97.5 %, 2.2 %, 0.3 %, and 0.1 % of patients, respectively. The mean (SD) time from the onset of symptoms to the start of ensitrelvir administration was 31.4 (43.6) h, with 91.8 % receiving treatment in <72 h of symptom onset. The ensitrelvir treatment period was 5 days in 97.4 % of patients and 6 days or longer in 1 patient. A total of 939 (25.0 %) patients had any HR factor, of whom 48.1 % were aged 65 years or older, 37.5 % had hypertension, and 26.9 % had dyslipidemia. None of the patients had a late pregnancy or HIV infection. Comorbidities occurred in 22.2 % of patients. Hepatic dysfunction and renal impairment were noted in 0.3 % and 0.4 % of patients, respectively. A total of 87.5 % of patients were taking concomitant medications, with anti-inflammatory drugs and analgesics being used for symptomatic treatment. The demographic and clinical characteristics of patients in the effectiveness analysis set were generally similar to those of patients in the safety analysis set.
Participant flow
A total of 4155 patients participated in the study, and 4125 case report forms were collected. After excluding 365 patients (major reasons [duplicate]: not administered ensitrelvir [n = 321], safety not assessed [n = 291]), 3760 patients were included in the safety analysis set. An additional 122 patients were excluded from the safety analysis set (unapproved dosage/administration [n = 111], asymptomatic cases [n = 10], and contraindications [n = 3]), and 3638 patients comprised the effectiveness analysis set.
Adverse events
In the safety analysis set, 379 ADRs were reported (serious n = 5, not serious n = 374). A total of 348 ADRs occurred within 5 days of initiating ensitrelvir, with most ADRs occurring on the second day of ensitrelvir administration (n = 138). A pregnancy test was positive in 1 patient after ensitrelvir administration; however, no ADRs were reported during the observation period. The most common ADR was diarrhoea (n = 91), followed by nausea (n = 43) and headache (n = 42). A total of 2/15 (13.3 %) patients with renal impairment and 269/3745 (7.2 %) patients without renal impairment experienced a non-serious ADR, there were no serious ADRs. There were no ADRs (serious/non-serious) in patients with hepatic dysfunction; there were 271/3750 (7.2 %) ADRs in patients without hepatic dysfunction, all of which were non-serious. The outcomes of ADRs were as follows: recovered (including remission; n = 344), not recovered (n = 10), and unknown (n = 25). None of the ADRs resulted in sequelae or death. The time to recovery or remission of ADRs was the highest in patients who displayed symptoms from 4 to 5 days (n = 91), followed by those who displayed symptoms from day 2 (n = 84) and day 3 (n = 80). Two ADRs (rash and hypokalaemia) persisted for 29 days or longer. The 5 serious ADRs in 3 patients were generalized oedema (patient 1), headache, nausea, cold sweat (patient 2), and vomiting (patient 3), and the events resolved within 3-5 days. Patient 1 did not require any treatment, patient 2 was treated with acetated Ringer's solution (Solacet F), amino acids, sugar, electrolytes, vitamin B1 (BFLUID), and metoclopramide; and patient 3 was hospitalized and received intravenous treatment.
Outcome measures
The median time to resolution of fever, all symptoms, systemic symptoms, respiratory symptoms, and gastrointestinal symptoms was 36.0 156.0, 60.0, and 132.0, and 48.0 h, respectively. Fourteen patients (0.4 %) were hospitalized for COVID-19 exacerbation (n = 10) or for other reasons (n = 6), with 2 patients being hospitalized for multiple reasons. There were 2 (0.1 %) deaths, none of which were attributed to COVID-19 or ensitrelvir administration.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 11 | Month | 22 | Day |
Date of IRB
| 2045 | Year | 12 | Month | 31 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 08 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a survey of actual ensitrelvir usage, so "ethics committee approval" are not required.
Management information
Registered date
| 2022 | Year | 12 | Month | 08 | 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=R000056642
