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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 4

Conditions: COVID-19

Treatments: Drug: Sotrovimab

Study type: Interventional

Funder types: Industry

Identifiers

NCT05305651

218407

Details and patient eligibility

About

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.

Enrollment: 217 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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217 participants in 1 patient group

Participants receiving Sotrovimab

Experimental group

Description:

Immunocompromised non-hospitalized participants will receive sotrovimab as standard of clinical care for COVID-19 in sentinel sites

Treatment:

Drug: Sotrovimab