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COMPLETED
NCT05305651
PHASE4

Study to Monitor the Occurrence of Viral Variants in Patients With Compromised Immune Systems Being Treated for COVID-19

Sponsor: GlaxoSmithKline

View on ClinicalTrials.gov

Summary

Sotrovimab binds to a conserved epitope on the severe acute respiratory syndrome coronavirus (SARS-CoV) and SARS-CoV-2 spike protein outside the receptor-binding motif and has been shown to reduce the risk of hospitalization and/or death when administered as early treatment in non-hospitalized patients that are at risk for progression to severe disease. Immunocompromised (IC) patients are prioritized to receive early treatment for COVID-19 as they are at high risk of disease progression, and because of their potential for prolonged viral shedding and the resulting increased risk of emergent viral mutations and potential onward community transmission. This genomic surveillance study will aim to describe changes in the SARS-CoV-2 spike protein observed in IC participants receiving sotrovimab as standard of clinical care in sentinel sites at a national level to assess potential emergence of viral variants.

Official title: Prospective Cohort Study to Monitor the Emergence of SARS-CoV-2 Spike Viral Variants in Immunocompromised Non-hospitalized Patients Exposed to Sotrovimab in Great Britain: LUNAR Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

217

Start Date

2022-07-01

Completion Date

2023-07-19

Last Updated

2026-10-06

Healthy Volunteers

No

Conditions

Interventions

DRUG

Sotrovimab

Sotrovimab dose and administration per standard of clinical care

Locations (8)

GSK Investigational Site

Birmingham, United Kingdom

GSK Investigational Site

Cambridge, United Kingdom

GSK Investigational Site

Cardiff, United Kingdom

GSK Investigational Site

London, United Kingdom

GSK Investigational Site

London, United Kingdom

GSK Investigational Site

Middlesbrough, United Kingdom

GSK Investigational Site

Newcastle upon Tyne, United Kingdom

GSK Investigational Site

Plymouth, United Kingdom