Last updated: 06/18/2025 10:30:31
XEVUDY® General Drug Use Investigation in Japan
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: XEVUDY General Drug Use Investigation (SARS-CoV-2 Infection)
Trial description: This study aims to collect and assess information about safety and effectiveness of XEVUDY in participants with severe acute respiratory syndrome coronavirus 2 (SARS- CoV-2) infection who have risk factors for progression to severe SARS-CoV-2 infection and do not require oxygen administration (OA) in daily clinical practice. XEVUDY is a registered trademark of GlaxoSmithKline group of companies.
Primary purpose:
Treatment
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Number of participants with adverse drug reactions
Timeframe: Up to Day 29
Secondary outcomes:
Percentage of participants assessed as responders
Timeframe: Up to Day 29
Number of participants with clinically significant changes in vital signs and clinical symptoms
Timeframe: Up to Day 29
Interventions:
Not applicable
Enrollment:
630
Primary completion date:
2023-30-10
Observational study model:
Cohort
Time perspective:
Prospective
Clinical publications:
Evaluation of the Safety and Efficacy of Sotrovimab in Patients With SARS-CoV-2 Infection in Japan: Final Report of the General Use Results Survey. Jpn J Infect Dis. 2024;(e24008) doi:10.11150/kansenshogakuzasshi.e24008 https://www.jstage.jst.go.jp/article/kansenshogakuzasshi/advpub/0/advpub_e24008/_article/-char/ja/
DOI: 10.11150/kansenshogakuzasshi.e24008
Medical condition
COVID-19
Product
sotrovimab
Collaborators
Not applicable
Study date(s)
February 2022 to October 2023
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
Not applicable
Accepts healthy volunteers
No
- Participants who have risk factors for progression to severe SARS-CoV-2 infection and do not require OA for SARS-CoV-2 infection at the beginning of XEVUDY administration and receive XEVUDY for the first time will be included in the study.
- This study is conducted under Japanese regulation and only participants who are administered XEVUDY in Japan can be enrolled in this study.
- No data available
Inclusion and exclusion criteria
Inclusion criteria:
- Participants who have risk factors for progression to severe SARS-CoV-2 infection and do not require OA for SARS-CoV-2 infection at the beginning of XEVUDY administration and receive XEVUDY for the first time will be included in the study.
- This study is conducted under Japanese regulation and only participants who are administered XEVUDY in Japan can be enrolled in this study.
Exclusion criteria:
- No data available
Trial location(s)
Study documents
Study report synopsis
Available language(s): English
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
2023-30-10
Actual study completion date
2023-30-10
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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