CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 217 enrolled
Drug / intervention
Sotrovimabdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05305651
NCT05305651Phase 4Completed

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

GlaxoSmithKline·interventional·Posted Mar 31, 2022·Updated Oct 15, 2024

In Brief

A Phase 4 clinical trial evaluating Sotrovimab for COVID-19. Completed, enrolled 217 participants across 8 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCOVID-19
CountriesUnited Kingdom
Collaborators--

Timeline

Phase 4CompletedFinished
2023202420252026
First PostedMar 31, 2022
Enrollment StartJul 1, 2022
Primary CompletionJul 17, 2023
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 4.3 years ago

Interventions

Sotrovimabdrug

Sotrovimab dose and administration per standard of clinical care