Ensitrelvir Fumaric Acid in Patients with SARS-CoV-2 - Retrospective Chart Review -

Ensitrelvir Fumaric Acid in Patients with SARS-CoV-2 - Retrospective Chart Review - - Ensitrelvir Fumaric Acid in Patients with SARS-CoV-2 - Retrospective Chart Review -

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000051300

Enrollment

Registered

2023-06-09

Start date

2023-04-21

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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 -Start date and end date of ensitrelvir administration -SARS-CoV-2 positive test result -Viral test results at the start and end of ensitrelvir administration -Outcomes of SARS-CoV-2 infection

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Viral antigen or PCR results (quantitative or qualitative results) at each time point from the start of administration to 10 days after the end of administration	—

Secondary

Measure	Time frame
Outcomes of SARS-CoV-2 infection up to 10 days after end of administration	—

Countries

Japan

Contacts

Public ContactMasahiro Kinoshita

Shionogi & Co., Ltd. Medical Affairs

masahiro.kinoshita@shionogi.co.jp06-6202-2161

Outcome results