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

January 23, 2023 updated by: GlaxoSmithKline

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

500

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Cambridge, United Kingdom, CB2 0QQ
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Effrossyni Gkrania-Klotsas
      • Cardiff, United Kingdom, CF14 4XW
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Jon Underwood
      • London, United Kingdom, SE1 7EH
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Anna Goodman
      • London, United Kingdom, NW1 2BU
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Michael Brown
      • Middlesbrough, United Kingdom, TS4 3BW
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • David R Chadwick
      • Newcastle upon Tyne, United Kingdom, NE1 4LP
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Ewan Hunter
      • Plymouth, United Kingdom, PL6 5FP
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Claire Bethune

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Cohort receiving Sotrovimab
Immunocompromised non-hospitalized participants will receive sotrovimab as standard of clinical care for COVID-19 in sentinel sites
Drug: Sotrovimab
Sotrovimab dose and administration per standard of clinical care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
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
Time Frame: Baseline (Day 0) and up to Day 28 (± 2 days)
Baseline (Day 0) and up to Day 28 (± 2 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Baseline (Day 0) and up to Day 28 (± 2 days)
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)
Baseline (Day 0) and up to Day 28 (± 2 days)
Proportion of participants with all cause hospital admissions and COVID-19 related hospital admissions
Time Frame: Up to Day 28 (± 2 days)
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)
Time Frame: Up to Day 28 (± 2 days)
Up to Day 28 (± 2 days)
Proportion of participants with all cause intensive care unit (ICU) admission
Time Frame: Up to Day 28 (± 2 days)
Up to Day 28 (± 2 days)
Proportion of participants with all cause deaths and COVID-19 related deaths
Time Frame: Up to Day 28 (± 2 days)
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
Time Frame: Baseline (Day 0) and up to Day 28 (± 2 days)
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)
Number of participants with AA changes in the consensus sequence (>50%) of SARS-CoV-2 spike protein samples from baseline following sotrovimab administration
Time Frame: Baseline (Day 0) and up to Day 28 (± 2 days)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2022

Primary Completion (Anticipated)

July 20, 2023

Study Completion (Anticipated)

November 15, 2023

Study Registration Dates

First Submitted

March 30, 2022

First Submitted That Met QC Criteria

March 30, 2022

First Posted (Actual)

March 31, 2022

Study Record Updates

Last Update Posted (Estimate)

January 24, 2023

Last Update Submitted That Met QC Criteria

January 23, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 218407

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD 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 Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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