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 type

• Study type:
  Clinical trial
• If ‘other’, further details on the scope of the study:
  Genomic Surveillance study

Study drug and medical condition

• Name of medicine:
  XEVUDY
• Study drug International non-proprietary name (INN) or common name:
  SOTROVIMAB
• Anatomical Therapeutic Chemical (ATC) code:
  (J06BD05) sotrovimab

  sotrovimab
• Medical condition to be studied:
  COVID-19

Population studied

• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Immunocompromised
• Estimated number of subjects:
  500

Study design details

• Main study objective:
  This genomic surveillance study will aim 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 potential emergence of viral variant.
• Outcomes:
  - Proportion of patients eligible for sequence analysis that have any amino acid change from Baseline in the epitope of sotrovimab binding in samples collected at Day 7, 14 and 28 (+/-2 days).; - Proportion of patients eligible for sequence analysis that have any amino acid change from Baseline in the spike protein in samples collected at Day 7, 14 and 28 (+/-2 days), 1. % pts with SARS CoV-2 variants (VOC/VUI), % pts with undetectable virus at Day(D) 7,14,28, 3.Clinical outcomes through D28, 4.AA changes in spike protein at D7,14,28 compared to BL for samples with viral load (VL) above threshold of sequencing assay, 5.AA changes in spike consensus sequences from BL in samples where VL is insufficient but sufficient to generate consensus level sequencing data.
• Data analysis plan:
  • Sequencing of Baseline (BL) & follow-up samples will be performed regularly. Following will be reported for patients (pts) eligible for sequencing analysis: Proportion of pts with amino acid (AA) change from BL in epitope of sotrovimab, Proportion of pts with AA change from BL in spike protein ; • For samples with viral load (VL) above threshold for allelic frequency determination, AA changes in SARS-CoV-2 spike protein at >5% allelic frequency compared to BL will be reported ; • For samples with VL below threshold for low (5%) allelic frequency analysis, but above threshold for consensus sequence generation, AA changes in SARS-CoV-2 spike protein consensus sequence from BL will be reported ; • For patients eligible for sequencing analysis, VOC, VUI & other lineages information as classified by UKHSA & WHO will be identified from sequencing data ; • Comorbidities, clinical outcomes, patients with undetectable virus & safety event data will be described & reported

Documents

Study report

CSR Anonymized 03 Jul 2024.pdf