Prospective cohort study to monitor the emergence of SARSCoV-2 spike viral variants in immunocompromised nonhospitalised patients exposed to sotrovimab in Great Britain: LUNAR study (218407)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/49384
• EU PAS number:
  EUPAS46386
• Study ID:
  49384
• Official title and acronym:
  Prospective cohort study to monitor the emergence of SARSCoV-2 spike viral variants in immunocompromised nonhospitalised patients exposed to sotrovimab in Great Britain: LUNAR study (218407)
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  The LUNAR study is genomic surveillance study that aims to describe changes in the SARS-CoV-2 spike protein observed in immunocompromised patients receiving sotrovimab as clinical standard of care in sentinel sites at a national level to assess the potential emergence of viral variants
• Study status:
  Finalised

Research institution and networks

Institutions

GlaxoSmithKline (GSK)

Study timelines

Date when funding contract was signed

Planned: 08/12/2021

Actual: 08/12/2021

Study start date

Planned: 01/07/2022

Actual: 01/07/2022

Date of final study report

Planned: 27/02/2024

Actual: 27/02/2024

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

GlaxoSmithKline

Study protocol

Initial protocol

gsk-218407-protocol-orig-redact.pdf

Regulatory

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