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

COVID-19 Clinical Trial

— LUNAR  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05305651
• Other study ID #: 218407
• Status: Recruiting
• Phase: Phase 4
• Start date: July 1, 2022
• Est. completion date: November 15, 2023

Study information

• Verified date: January 2023
• Source: GlaxoSmithKline
• Contact: US GSK Clinical Trials Call Center
• Phone: 877-379-3718
• Email: GSKClinicalSupportHD[@]gsk.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: November 15, 2023
• Est. primary completion date: July 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participants must be adult and of greater than or equal to (>=) 18 years of age or older at the time of consent

• Participants must be immunocompromised (IC) population eligible to receive sotrovimab

• A positive polymerase chain reaction (PCR) or antigen test for SARS-CoV-2 through clinical testing or routine screening undertaken as part of clinical management

• Prescribed treatment with sotrovimab as standard of clinical care

• Able to provide informed consent and willing to adhere to study-related procedures

Exclusion Criteria:

• Participants who require hospitalization (related or not to COVID-19) at baseline

• Participants who initiated sotrovimab therapy in inpatient settings

• Participants unable to perform nasal/oropharyngeal sample collection

• Blinded participants from other COVID-19 related trials

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• Sotrovimab
Sotrovimab dose and administration per standard of clinical care

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Case JB, Mackin S, Errico JM, Chong Z, Madden EA, Whitener B, Guarino B, Schmid MA, Rosenthal K, Ren K, Dang HV, Snell G, Jung A, Droit L, Handley SA, Halfmann PJ, Kawaoka Y, Crowe JE Jr, Fremont DH, Virgin HW, Loo YM, Esser MT, Purcell LA, Corti D, Diamond MS. Resilience of S309 and AZD7442 monoclonal antibody treatments against infection by SARS-CoV-2 Omicron lineage strains. Nat Commun. 2022 Jul 2;13(1):3824. doi: 10.1038/s41467-022-31615-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of participants eligible for sequence analysis with amino acids (AA) change from baseline in the epitope of sotrovimab binding		Baseline (Day 0) and up to Day 28 ([plus-minus] ± 2 days)
Primary	Proportion of participants eligible for sequence analysis that have any AA, change from baseline in the spike protein		Baseline (Day 0) and up to Day 28 (± 2 days)
Secondary	Proportion of participants eligible for sequence analysis with variants of concern (VOC) and variants under investigation (VUI) on the earliest possible sample including baseline		Baseline (Day 0) and up to Day 28 (± 2 days)
Secondary	Proportion of participants with undetectable virus by reverse transcriptase polymerase chain reaction (RT-PCR)		Baseline (Day 0) and up to Day 28 (± 2 days)
Secondary	Proportion of participants with all cause hospital admissions and COVID-19 related hospital admissions		Up to Day 28 (± 2 days)
Secondary	Proportion of participants on new or increased oxygen support, including those requiring mechanical ventilation or extracorporeal membrane oxygenation (ECMO)		Up to Day 28 (± 2 days)
Secondary	Proportion of participants with all cause intensive care unit (ICU) admission		Up to Day 28 (± 2 days)
Secondary	Proportion of participants with all cause deaths and COVID-19 related deaths		Up to Day 28 (± 2 days)
Secondary	Number of participants with AA changes in SARS-CoV-2 spike protein is >5% in samples compared to baseline following sotrovimab administration	For samples with viral load above the threshold for allelic frequency determination, AA changes in SARS-CoV-2 spike protein at greater than (>) 5 percentage (%) allelic frequency compared to baseline will be reported	Baseline (Day 0) and up to Day 28 (± 2 days)
Secondary	Number of participants with AA changes in the consensus sequence (>50%) of SARS-CoV-2 spike protein samples from baseline following sotrovimab administration	For samples with viral load below the threshold for low (5%) allelic frequency analysis, but above the threshold for consensus sequence generation, AA changes in the SARS-CoV-2 spike protein consensus sequence (> 50%) from baseline will be reported	Baseline (Day 0) and up to Day 28 (± 2 days)