Last updated: 07/04/2025 03:30:32
Study to monitor the occurrence of viral variants in patients with compromised immune systems being treated for COVID-19LUNAR
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:
Proportion of participants eligible for sequence analysis with amino acids (AA) change from baseline in the epitope of sotrovimab binding
Timeframe: Baseline (Day 0) and up to Day 28 ([plus-minus] ± 2 days)
Proportion of participants eligible for sequence analysis that have any AA, change from baseline in the spike protein
Timeframe: Baseline (Day 0) and up to Day 28 (± 2 days)
Secondary outcomes:
Proportion of participants eligible for sequence analysis with variants of concern (VOC) and variants under investigation (VUI) on the earliest possible sample including baseline
Timeframe: Baseline (Day 0) and up to Day 28 (± 2 days)
Proportion of participants with undetectable virus by reverse transcriptase polymerase chain reaction (RT-PCR)
Timeframe: Baseline (Day 0) and up to Day 28 (± 2 days)
Proportion of participants with all cause hospital admissions and COVID-19 related hospital admissions
Timeframe: Up to Day 28 (± 2 days)
Proportion of participants on new or increased oxygen support, including those requiring mechanical ventilation or extracorporeal membrane oxygenation (ECMO)
Timeframe: Up to Day 28 (± 2 days)
Proportion of participants with all cause intensive care unit (ICU) admission
Timeframe: Up to Day 28 (± 2 days)
Proportion of participants with all cause deaths and COVID-19 related deaths
Timeframe: Up to Day 28 (± 2 days)
Number of participants with AA changes in SARS-CoV-2 spike protein is >5% in samples compared to baseline following sotrovimab administration
Timeframe: Baseline (Day 0) and up to Day 28 (± 2 days)
Number of participants with AA changes in the consensus sequence (>50%) of SARS-CoV-2 spike protein samples from baseline following sotrovimab administration
Timeframe: Baseline (Day 0) and up to Day 28 (± 2 days)
Interventions:
Enrollment:
217
Primary completion date:
2023-17-07
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Judith Breuer, Myriam Drysdale, Jill Walker, Jennifer Han, Alicia Aylott, Melissa K Van Dyke, Helen J Birch, Elizabeth McKie, William Jordan, Kim Gemzoe, Iain A Gillespie, Claire Bethune, Charlotte A Williams, Jonathan Underwood, Anna L Goodman, Michael Brown, Julianne R Brown, Rachel Williams, Luz Marina Martin Bernal, Laura Buggiotti, Effrossyni Gkrania-Klotsas, Clara Green, Ewan Hunter, Charles Miller, Andrew Skingsley, David M Lowe. Monitoring the emergence of resistance with sotrovimab in immunocompromised patients with COVID-19: LUNAR study. The Journal of infection. 2025-May-19;91(1): 106510. doi:10.1016/j.jinf.2025.106510 https://www.sciencedirect.com/science/article/pii/S0163445325001045
PMID: 40398499
DOI: 10.1016/j.jinf.2025.106510
Medical condition
COVID-19
Product
sotrovimab
Collaborators
Not applicable
Study date(s)
July 2022 to July 2023
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- 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
- Participants who require hospitalization (related or not to COVID-19) at baseline
- Participants who initiated sotrovimab therapy in inpatient settings
Inclusion and exclusion 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
Trial location(s)
Location
GSK Investigational Site
NEWCASTLE UPON TYNE, United Kingdom, NE1 4LP
Status
Study Complete
Showing 1 - 6 of 8 Results
Study documents
Study report synopsis
Available language(s): English
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2023-17-07
Actual study completion date
2023-19-07
Plain language summaries
Summary of results in plain language
Available language(s): English
To view plain language summaries on trialsummaries.com click here.
Additional information about the trial
Additional information
Not applicable
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