NCT05305651

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 217 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• COVID-19

Interventions

Type	Name	Description
DRUG	Sotrovimab	Sotrovimab dose and administration per standard of clinical care

Timeline

• Start date: 2022-07-01
• Primary completion: 2023-07-17
• Completion: 2023-07-17
• First posted: 2022-03-31
• Last updated: 2024-10-15
• Results posted: 2024-10-15

Locations

8 sites across 1 country: United Kingdom