UMIN-CTR Clinical Trial

Public title

Ensitrelvir Fumaric Acid in Patients with COVID-19 Retrospective Chart Review - Kimoto Internal Medicine Clinic -

Acronym

Ensitrelvir Fumaric Acid in Patients with COVID-19 Retrospective Chart Review - Kimoto Internal Medicine Clinic -

Scientific Title

Ensitrelvir Fumaric Acid in Patients with SARS-CoV-2 Retrospective Chart Review - Kimoto Internal Medicine Clinic -

Scientific Title:Acronym

Ensitrelvir Fumaric Acid in Patients with SARS-CoV-2 Retrospective Chart Review - Kimoto Internal Medicine Clinic -

Region

Japan

Condition

COVID-19

Classification by specialty

Infectious disease

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate the background of patients with SARS-CoV-2 infection who received ensitrelvir fumaric acid, and clinical outcomes and safety.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Clinical symptoms at each time point from the start to Day 7 of ensitrelvir administration

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

30

Name of lead principal investigator

1st name	Hirokazu
Middle name
Last name	Sakamoto

Organization

Kimoto Internal Medicine Clinic

Division name

Director

Zip code

590-0400

Address

1-15, Wada 1-chome, Kumatori-cho, Sennan-gun, Osaka

TEL

072-453-3306

Email

hirobooboo42@yahoo.co.jp

Name of contact person

1st name	Yasuko
Middle name
Last name	Ariwa

Organization

Shionogi & Co., Ltd.

Division name

Medical Affairs

Zip code

541-0045

Address

1-8, Dosho-machi 3-chome, Chuo-ku, Osaka 541-0045, Japan

TEL

06-6202-2161

Homepage URL

Email

yasuko.ariwa@shionogi.co.jp

Institute

Shionogi & Co., Ltd.

Institute

Department

Personal name

Organization

Shionogi & Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Non-Profit Organization MINS Institutional Review Board

Address

20-9-401,Mita 5-chome, Minato-ku, Tokyo

Tel

03-6416-1868

Email

npo-mins@j-irb.com

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2023

Year

06

Month

28

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

32

Results

The study enrolled 32 people, and the main COVID-19 symptoms included sore throat in 22 patients and fever in 21 patients. No sore throat was observed 7 days after the start of administration. Fever and cough decreased to 8 and 3 patients on the second day, and no fever was confirmed on the seventh day.
Two patients reported nausea as a side effect of ensitrevir, but both were mild.

Results date posted

2023

Year

12

Month

11

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

The study enrolled 32 people aged 12 to 64, all of whom tested positive for SARS-CoV-2 and had mild COVID-19 severity. Patients with risk factors for severe illness listed in administrative communications from the Japanese authorities as of January 2023 were not included.

Participant flow

Adverse events

Nausea was reported by 2 patients as a side effect of ensitrevir, but both were mild.

Outcome measures

Clinical symptoms at each time point from the start to Day 7 of ensitrelvir administration

Plan to share IPD

IPD sharing Plan description

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 related information

None

Registered date

2023

Year

06

Month

27

Day

Last modified on

2023

Year

12

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058702