Unique ID issued by UMIN | UMIN000051461 |
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Receipt number | R000058699 |
Scientific Title | Ensitrelvir Fumaric Acid in Patients with SARS-CoV-2 Retrospective Chart Review - Toyohira Park Internal Medicine Clinic - |
Date of disclosure of the study information | 2023/06/28 |
Last modified on | 2023/12/11 14:45:52 |
Ensitrelvir Fumaric Acid in Patients with COVID-19 Retrospective Chart Review - Toyohira Park Internal Medicine Clinic -
Ensitrelvir Fumaric Acid in Patients with COVID-19 Retrospective Chart Review - Toyohira Park Internal Medicine Clinic -
Ensitrelvir Fumaric Acid in Patients with SARS-CoV-2 Retrospective Chart Review - Toyohira Park Internal Medicine Clinic -
Ensitrelvir Fumaric Acid in Patients with SARS-CoV-2 Retrospective Chart Review - Toyohira Park Internal Medicine Clinic -
Japan |
COVID-19
Infectious disease |
Others
NO
To evaluate the background of patients with SARS-CoV-2 infection who received ensitrelvir fumaric acid, and clinical outcomes and safety.
Safety,Efficacy
Exploratory
Not applicable
Clinical symptoms at each time point from the start to Day 6 of ensitrelvir administration
Not applicable
Observational
Not applicable |
Not applicable |
Male and Female
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
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
45
1st name | Akiko |
Middle name | |
Last name | Fujimoto |
Toyohira Park Internal Medicine Clinic
Director
062-0904
3-5, Toyohira 4-jyo 11-chome, Toyohira-ku, Sapporo-shi, Hokkaido
011-811-1518
akiko-fujimoto@hokkaido.med.or.jp
1st name | Kentarou |
Middle name | |
Last name | Shibata |
Shionogi & Co., Ltd.
Medical Affairs
100-0005
8-2, Marunouchi 1-chome, Chiyoda-ku, Tokyo
03-5219-7306
kentarou.shibata@shionogi.co.jp
Shionogi & Co., Ltd.
Shionogi & Co., Ltd.
Profit organization
Japan
Non-Profit Organization MINS Institutional Review Board
20-9-401,Mita 5-chome, Minato-ku, Tokyo
03-6416-1868
npo-mins@j-irb.com
NO
2023 | Year | 06 | Month | 28 | Day |
Published
http://hokuryukan-ns.co.jp/cms/wp-content/uploads/2023/10/BIO202311_Clinical_outcomes_after_administ
47
All 47 patients enrolled in the study were mildly ill, and 9 patients had risk factors for severe disease. All patients, regardless of risk factors for severe disease, showed rapid improvement of fever and clinical symptoms, and no patient developed severe disease. The only side effects were mild diarrhea and soft stool.
2023 | Year | 12 | Month | 11 | Day |
2023 | Year | 10 | Month | 23 | Day |
Approximately 55% were male, and the average age was 42.4 years.
Of the 49 collected cases, 47 were included in the analysis.
Diarrhea (4 patients) or loose stools (3 patients, with overlap in 1 patient) were observed in 6 patients, but both were mild.
-Clinical symptoms at each time point from the start to Day 6 of ensitrelvir administration
-Incidence of rates of ADRs
Completed
2023 | Year | 05 | Month | 08 | Day |
2023 | Year | 06 | Month | 22 | Day |
2023 | Year | 07 | Month | 01 | Day |
2023 | Year | 07 | Month | 31 | Day |
None
2023 | Year | 06 | Month | 27 | Day |
2023 | Year | 12 | Month | 11 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058699
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