Back to resultsStudy to Monitor the Occurrence of Viral Variants in Patients With Compromised Immune Systems Being Treated for COVID-19 (LUNAR)
Primary Purpose
COVID-19
Status
Recruiting
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Sotrovimab
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19 focused on measuring SARS CoV-2, LUNAR, Coronavirus disease 2019 (COVID-19), Pandemic, Sotrovimab, Monoclonal antibody, Immunocompromised (IC)
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
Sites / Locations
- GSK Investigational SiteRecruiting
- GSK Investigational SiteRecruiting
- GSK Investigational SiteRecruiting
- GSK Investigational SiteRecruiting
- GSK Investigational SiteRecruiting
- GSK Investigational SiteRecruiting
- GSK Investigational SiteRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Cohort receiving Sotrovimab
Arm Description
Immunocompromised non-hospitalized participants will receive sotrovimab as standard of clinical care for COVID-19 in sentinel sites
Outcomes
Primary Outcome Measures
Proportion of participants eligible for sequence analysis with amino acids (AA) change from baseline in the epitope of sotrovimab binding
Proportion of participants eligible for sequence analysis that have any AA, change from baseline in the spike protein
Secondary Outcome Measures
Proportion of participants eligible for sequence analysis with variants of concern (VOC) and variants under investigation (VUI) on the earliest possible sample including baseline
Proportion of participants with undetectable virus by reverse transcriptase polymerase chain reaction (RT-PCR)
Proportion of participants with all cause hospital admissions and COVID-19 related hospital admissions
Proportion of participants on new or increased oxygen support, including those requiring mechanical ventilation or extracorporeal membrane oxygenation (ECMO)
Proportion of participants with all cause intensive care unit (ICU) admission
Proportion of participants with all cause deaths and COVID-19 related deaths
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05305651
Brief Title
Study to Monitor the Occurrence of Viral Variants in Patients With Compromised Immune Systems Being Treated for COVID-19
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
July 20, 2023 (Anticipated)
Study Completion Date
November 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
SARS CoV-2, LUNAR, Coronavirus disease 2019 (COVID-19), Pandemic, Sotrovimab, Monoclonal antibody, Immunocompromised (IC)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cohort receiving Sotrovimab
Arm Type
Other
Arm Description
Immunocompromised non-hospitalized participants will receive sotrovimab as standard of clinical care for COVID-19 in sentinel sites
Intervention Type
Drug
Intervention Name(s)
Sotrovimab
Intervention Description
Sotrovimab dose and administration per standard of clinical care
Primary Outcome Measure Information:
Title
Proportion of participants eligible for sequence analysis with amino acids (AA) change from baseline in the epitope of sotrovimab binding
Time Frame
Baseline (Day 0) and up to Day 28 ([plus-minus] ± 2 days)
Title
Proportion of participants eligible for sequence analysis that have any AA, change from baseline in the spike protein
Time Frame
Baseline (Day 0) and up to Day 28 (± 2 days)
Secondary Outcome Measure Information:
Title
Proportion of participants eligible for sequence analysis with variants of concern (VOC) and variants under investigation (VUI) on the earliest possible sample including baseline
Time Frame
Baseline (Day 0) and up to Day 28 (± 2 days)
Title
Proportion of participants with undetectable virus by reverse transcriptase polymerase chain reaction (RT-PCR)
Time Frame
Baseline (Day 0) and up to Day 28 (± 2 days)
Title
Proportion of participants with all cause hospital admissions and COVID-19 related hospital admissions
Time Frame
Up to Day 28 (± 2 days)
Title
Proportion of participants on new or increased oxygen support, including those requiring mechanical ventilation or extracorporeal membrane oxygenation (ECMO)
Time Frame
Up to Day 28 (± 2 days)
Title
Proportion of participants with all cause intensive care unit (ICU) admission
Time Frame
Up to Day 28 (± 2 days)
Title
Proportion of participants with all cause deaths and COVID-19 related deaths
Time Frame
Up to Day 28 (± 2 days)
Title
Number of participants with AA changes in SARS-CoV-2 spike protein is >5% in samples compared to baseline following sotrovimab administration
Description
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
Time Frame
Baseline (Day 0) and up to Day 28 (± 2 days)
Title
Number of participants with AA changes in the consensus sequence (>50%) of SARS-CoV-2 spike protein samples from baseline following sotrovimab administration
Description
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
Time Frame
Baseline (Day 0) and up to Day 28 (± 2 days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name or Official Title & Degree
EU GSK Clinical Trials Call Center
Phone
+44 (0) 20 89904466
Email
GSKClinicalSupportHD@gsk.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Effrossyni Gkrania-Klotsas
Facility Name
GSK Investigational Site
City
Cardiff
ZIP/Postal Code
CF14 4XW
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Jon Underwood
Facility Name
GSK Investigational Site
City
London
ZIP/Postal Code
NW1 2BU
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Michael Brown
Facility Name
GSK Investigational Site
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Anna Goodman
Facility Name
GSK Investigational Site
City
Middlesbrough
ZIP/Postal Code
TS4 3BW
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
David R Chadwick
Facility Name
GSK Investigational Site
City
Newcastle upon Tyne
ZIP/Postal Code
NE1 4LP
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Ewan Hunter
Facility Name
GSK Investigational Site
City
Plymouth
ZIP/Postal Code
PL6 5FP
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Claire Bethune
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD for this study will be made available via the Clinical Study Data Request site.
IPD Sharing Time Frame
IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data of the study.
IPD Sharing Access Criteria
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
IPD Sharing URL
http://clinicalstudydatarequest.com
Citations:
PubMed Identifier
35780162
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.
Results Reference
background
Learn more about this trial
Study to Monitor the Occurrence of Viral Variants in Patients With Compromised Immune Systems Being Treated for COVID-19
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