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