Phase 4
N=217
Study to Monitor the Occurrence of Viral Variants in Patients With Compromised Immune Systems Being Treated for COVID-19
COVID-19
Bottom Line
View on ClinicalTrials.gov: NCT05305651 ↗Enrolled (actual)
217
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcome: Primary: Number of Participants With Treatment Emergent Amino Acid Substitutions Greater Than (>) 5 Percent (%) and >50% Allelic Frequency in the Sotrovimab Epitope at Day 7 — 38; 12 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Sotrovimab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Jul 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment Emergent Amino Acid Substitutions Greater Than (>) 5 Percent (%) and >50% Allelic Frequency in the Sotrovimab Epitope at Day 7 |
38; 12 | — |
| PRIMARY Number of Participants With Treatment Emergent Amino Acid Substitutions >5% and >50% Allelic Frequency in the Sotrovimab Epitope at Day 14 |
18; 11 | — |
| PRIMARY Number of Participants With Treatment Emergent Amino Acid Substitutions >5% and >50% Allelic Frequency in the Sotrovimab Epitope at Day 28 |
11; 11 | — |
| PRIMARY Number of Participants With Treatment Emergent Amino Acid Substitutions >5% and >50% Allelic Frequency in the Spike Protein at Day 7 |
88; 19 | — |
| PRIMARY Number of Participants With Treatment Emergent Amino Acid Substitutions >5% and >50% Allelic Frequency in the Spike Protein at Day 14 |
37; 17 | — |
| PRIMARY Number of Participants With Treatment Emergent Amino Acid Substitutions >5% and >50% Allelic Frequency in the Spike Protein at Day 28 |
20; 13 | — |
| SECONDARY Number of Participants With Variants of Concern (VOC) or Variants Under Investigation (VUI) |
208 | — |
| SECONDARY Number of Participants With Undetectable Virus by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) |
50; 129; 162 | — |
| SECONDARY Number of Participants With All Cause Hospital Stay |
7 | — |
| SECONDARY Number of Participants With COVID-19 Related Hospital Stay |
— | — |
| SECONDARY 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) |
1; 1; 0; 0 | — |
| SECONDARY Number of Participants With All Cause Intensive Care Unit (ICU) Hospital Stay |
— | — |
| SECONDARY Number of Participants With COVID-19 Related ICU Hospital Stay |
— | — |
| SECONDARY Number of Participants Who Died Due to Any Cause Through Day 28 |
1 | — |
| SECONDARY Number of Participants Who Died Due to COVID-19 Through Day 28 |
— | — |
| SECONDARY Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5% |
1; 1; 1; 1; 1; 1 | — |
| SECONDARY Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >50% |
1; 1; 3; 1; 2; 1 | — |
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
Data sourced from ClinicalTrials.gov (NCT05305651). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.