Clinical trial NCT05305651: Study to Monitor the Occurrence of Viral Variants in Patients With Compromised Immune Systems Being Treated for COVID-19
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: COVID-19
Keywords: SARS CoV-2
LUNAR
Coronavirus disease 2019 (COVID-19)
Pandemic
Sotrovimab
Monoclonal antibody
Immunocompromised (IC)
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2022-03-31
Enrollment: 217
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This study is a prospective cohort study which will enroll IC non-hospitalized participants receiving sotrovimab treatment as per standard of clinical care for COVID-19 in sentinel sites.
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Treatment Emergent Amino Acid Substitutions Greater Than (>) 5 Percent (%) and >50% Allelic Frequency in the Sotrovimab Epitope at Day 7
timeFrame: At Day 7
measure: Number of Participants With Treatment Emergent Amino Acid Substitutions >5% and >50% Allelic Frequency in the Sotrovimab Epitope at Day 14
timeFrame: At Day 14
measure: Number of Participants With Treatment Emergent Amino Acid Substitutions >5% and >50% Allelic Frequency in the Sotrovimab Epitope at Day 28
timeFrame: At Day 28
measure: Number of Participants With Treatment Emergent Amino Acid Substitutions >5% and >50% Allelic Frequency in the Spike Protein at Day 7
timeFrame: At Day 7
measure: Number of Participants With Treatment Emergent Amino Acid Substitutions >5% and >50% Allelic Frequency in the Spike Protein at Day 14
timeFrame: At Day 14
measure: Number of Participants With Treatment Emergent Amino Acid Substitutions >5% and >50% Allelic Frequency in the Spike Protein at Day 28
timeFrame: At Day 28
Secondary outcomes:
measure: Number of Participants With Variants of Concern (VOC) or Variants Under Investigation (VUI)
timeFrame: Up to Day 28
measure: Number of Participants With Undetectable Virus by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)
timeFrame: At Day 7, Day 14, and Day 28
measure: Number of Participants With All Cause Hospital Stay
timeFrame: Up to Day 28
measure: Number of Participants With COVID-19 Related Hospital Stay
timeFrame: Up to Day 28
measure: Number of Participants Requiring New or Increased Oxygen Support (Supplemental Oxygen [Not High Flow]), Non-invasive Ventilation or High-flow, Invasive Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO)
timeFrame: Up to Day 28
measure: Number of Participants With All Cause Intensive Care Unit (ICU) Hospital Stay
timeFrame: Up to Day 28
measure: Number of Participants With COVID-19 Related ICU Hospital Stay
timeFrame: Up to Day 28
measure: Number of Participants Who Died Due to Any Cause Through Day 28
timeFrame: Up to Day 28
measure: Number of Participants Who Died Due to COVID-19 Through Day 28
timeFrame: Up to Day 28
measure: Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
timeFrame: At Day 7, Day 14 and Day 28
measure: Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >50%
timeFrame: At Day 7, Day 14 and Day 28
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: GSK Investigational Site
city: Cardiff
country: United Kingdom
facility: GSK Investigational Site
city: EdgbastonBirmingham
country: United Kingdom
facility: GSK Investigational Site
city: London
country: United Kingdom
facility: GSK Investigational Site
city: London
country: United Kingdom
facility: GSK Investigational Site
city: Middlesbrough
country: United Kingdom
facility: GSK Investigational Site
city: Newcastle upon Tyne
country: United Kingdom
facility: GSK Investigational Site
city: Plymouth
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.