Unique ID issued by UMIN | UMIN000051482 |
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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 | 2023/12/11 15:44:33 |
Ensitrelvir Fumaric Acid in Hospitalized Patients with COVID-19 Retrospective Chart Review -Tomita Hospital-
Ensitrelvir Fumaric Acid in Hospitalized Patients with COVID-19 Retrospective Chart Review -Tomita Hospital-
Ensitrelvir Fumaric Acid in Hospitalized Patients with SARS-CoV-2 Retrospective Chart Review -Tomita Hospital-
Ensitrelvir Fumaric Acid in Hospitalized Patients with SARS-CoV-2 Retrospective Chart Review -Tomita Hospital-
Japan |
COVID-19
Infectious disease |
Others
NO
To evaluate the background of hospitalized patients with SARS-CoV-2 infection who received ensitrelvir fumaric acid, the virologic and clinical outcomes, and safety.
Safety,Efficacy
Exploratory
Not applicable
Clinical symptoms, oxygen saturation, and food amount at each time point from the start to Day 10 of ensitrelvir administration.
Outcomes of SARS-CoV-2 infection up to 10 days after the end of administration
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
(4)Outcomes of SARS-CoV-2 infection
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
10
1st name | Takafumi |
Middle name | |
Last name | Tomita |
Tomita Hospital
Director
649-6253
2, Kisendai Iwade-shi, Wakayama-ken
0736-62-1522
white-heaven@leto.eonet.ne.jp
1st name | Kentarou |
Middle name | |
Last name | Shibata |
Shionogi & Co., Ltd.
Medical Affairs
100-0005
7F, Tekko Building, 8-2, Marunouchi 1-chome, Chiyoda-ku, Tokyo
03-5219-7310
kentarou.shibata@shionogi.co.jp
Shionogi & Co., Ltd.
Shionogi & Co., Ltd.
Profit organization
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 | 30 | Day |
Unpublished
No longer recruiting
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 | 29 | Day |
2023 | Year | 12 | Month | 11 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058732
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