XEVUDY General Drug Use Investigation (SARS-CoV-2 Infection) - COVID-19 (217893)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/103975
• EU PAS number:
  EUPAS103974
• Study ID:
  103975
• Official title and acronym:
  XEVUDY General Drug Use Investigation (SARS-CoV-2 Infection) - COVID-19 (217893)
• DARWIN EU® study:
  No
• Study countries:
  Japan
• Study 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.
• Study status:
  Finalised

Research institutions and networks

Institutions

GlaxoSmithKline (GSK)

SHOWA University Hospital Tokyo, Japan

Study timelines

Date when funding contract was signed

Actual: 09/06/2020

Study start date

Planned: 28/02/2022

Actual: 07/02/2022

Date of final study report

Planned: 31/12/2024

Actual: 06/11/2023

Sources of funding

Other

Pharmaceutical company and other private sector 

More details on funding

GlaxoSmithKline (GSK), Vir Biotechnology (VIR)

Study protocol

Initial protocol

Sotrovimab_PMS_Protocol_in_Japan_Anonymized

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Non-EU RMP only